Month: September 2020

MFR of Spiramycin Tablet

Posted on By ABHA

Spiramycin Tablet

PURPOSE:  This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

Master Copy: Manager Quality Assurance

Copy No. 1: Production Pharmacist

Copy No. 2: Manager Quality Control

Copy No. 3: Tablet Section

PRODUCT NAME: Spiramycin TabletBATCH SIZE: 100,000
PRODUCT REFERENCE CODE: NAUNIT SIZE: 10 x 10
GENERIC NAME: N.A.PACK SIZE: 25x 10 x 10
DOSAGE FORM: TABLETSTRENGTH: N.A.
DEPARTMENT:  TABLET DEPARTMENTEXPIRY DATE: AFTER 27 MONTHS   FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each film coated Tablet contains:

Spiramycin                                                      3                M.I.U

EQUIPMENTS TO BE USED:

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1Steam Jacketed Starch Paste Preparation Tank
2Sifter Machine
3Roto Cube Blender
4Rapid Mixer Granulator
5Multi Mill
6Fluidized Bed Drier
7Oscillating Granulator
8Sifter Machine
9Roto Cube Blender
10Tablet Compression Machine 20 Stations
11Dedusting Machine
12Colloid Mill
13Tablet Inspection Machine
14Rapid Coat Tablet Coating Machine
15Single Track Blister Packing Machine

RAW MATERIAL:-

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.AerosilI.P.0.0500.05 0 kg.
2.Spiramycin base–75.0006.6780.000 kg.
3.S.L.SI.P.0.2000.200 kg.
4.Isopropyl AlcoholI.P16.5016.500 kg.
5.Instacoat whiteI.P2.1002.100 kgs.
6.M.C.C.PI.P.4.0004.000 kg.
7.Magnesium StearateI.P.0.5000.500 kg.
8.Methylene chlorideI.P.28.50028.500 kg.
9.StarchI.P8.0008.000 kg.
10.StarchI.P0.5000.500 kgs
11.StarchI.P0.4000.400 kgs
12.TalcumI.P.0.6000.600 kgs
13.Croscarmellose SodiumI.P1.0001.000 kg
14.M.P.B.SI.P0.2000.200 kg
15.P.P.B.SI.P0.0500.050 kg
16.S.S.GI.P0.5000.500 kg

PACKING MATERIAL:-

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1.ADHESIVE TAPE ROLL BROWN1.0001.000 KGS
2.SPIRAMAC-1000 ALUMINIUM FOIL (FRONT)22.00022.000 KGS
3CELLO TAPE1.0001.000 NOS
4UNIT CARTON

(SPIRAMAC-1000 MG TABS)

10000.0002.00010002.00 NOS
5CORRUGATED BOXES S-5540.00040.000 NOS
6.OUTER CARTON (10X10) (SPIRAMAC-1000 MG TABS)10002.000  1002.00 NOS
7.SPIRAMAC-500/1000 MG TABS INSERTS100002.00010002.00 NOS
8.SPIRAMAC-1000 ALUMINIUM FOIL (BACK)22.00022.000 KGS

MANUFACTURING SPECIFICATION:

Moisture content of powder should be less than 2.0 %.

Average weight of each Tablet is 955 milligrams.

Weight Variation Limit for average weight of 20 tablets is +0 %.

Friability limit for 10 Tablets is not more than 1.0 %.

Hardness of the Tablets varies between 4 – 6 kg/cm2.

Disintegration time for each Tablet is not more than 30 minutes.

Mix the batch, compress and de-dust the tablets and also perform the primary packing of Tablets at temperature not more than 25˚ C.

Perform the coating of the tablets at temperature not more than 25˚ C and humidity not more than 40%.

Yield:

Theoretical Yield is 100,000 Tablets.

Expected Practical Yield is 100,000 + 2% Tablets.

Packing Details:

Use Aluminium strip foil for strip packing.

Strip Pack the inspected tablets by using Strip Packing Machine as per its SOP.

Put 10 strips each containing 10 tablets in each inner carton.

Seal each outer carton from both ends with cello tape.

Pack 25 outer cartons in specified corrugated box to give a pack size of 25 x10X 10 tablets.

Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.

Manufacturing Process:

Preparation of Starch Paste: Prepare the starch paste in the manner given below using Steam Jacketed Starch Paste Preparation Tank by operating it as per its SOP. Dissolve 0.200 kg & 0.050 kg of P.P.B.S in 01 litre of water.

Add 0.500 kg of Starch in 1 Ltr purified water and stir continuously to make smooth slurry.

Take 10 Ltrs of boiling water add the solution of starch slurry with constant stirring to get a uniform paste.

Sifting: Fit Stainless Steel Sieve #40 on the Sifter-I as per its SOP. Sift all the ingredients through it and collect separately in Stainless Steel Containers.

Blending: Blend the following ingredients using Roto Cube Blender by operating it as per its SOP for 60 minutes and collect in Stainless Steel Container.

Spiramycin

M.C.C.P

Starch

Wet Granulation: Mix the above blended ingredients with the Starch paste using Rapid Mixer Granulator by operating it as per its SOP. Add starch paste in such a manner by following the procedure given below so as to achieve proper wetting.

Mix the blended powder and starch paste together in Rapid Mixer Granulator

Drying: Dry the granules in Fluidized Bed Drier by operating it as per its SOP at temperature 600 – 700 C for 30 minutes. Cool the granules to room temperature

Sifting: Fit Stainless Steel Sieve # 20 on the Sifter-II as per its SOP. Sift all the ingredients through it and collect in Stainless Steel Container. Break the oversized granules left over the mesh in Oscillating Granulator by operating it as per its SOP and resift them.

Check the total weight of dried granules. Determine the loss on drying and percentage yield of dried granules.

Lubrication: Add the following lubricating agents & granules to the Roto Cube Blender and operate it as per SOP  for 15 minutes. Collect the blended powder in Stainless Steel Container.

S.L.S

Aerosil

Starch

Magnesium Stearate

Talcum

Croscarmellose sodium0

Send the granules for bulk testing to Quality Control Department for assay of Active Ingredients.

Compression: Shift all the granules for compression to Tablet Compression Machine 27 Stations by operating it as per its SOP and collect the compressed tablets in Stainless Steel Container.                                                                                                                                                                                                                                                   Inspection: Transfer all the tablets to tablet inspection machine and sort out the defected tablet by operating it as per its SOP and collect the selected tablets in Stainless Steel Container.

Coating of the tablet: Dissolve 2.10 kgs of Instacoat White in 16.50 kgs of Isopropyl Alcohol. Then add 28.50 kgs of Methylene chloride to this solution. Collide this solution by Colloidal Mill as per SOP Now start coating of the tablets by using Rapid Cota Tablet Coating Machine by operating it as per its SOP and collect the coated tablets in Stainless Steel Container.

Tablet Inspection: Transfer all coated tablets to tablet inspection machine and sort out the defected tablet by operating it as per its SOP and collect the selected tablets in Stainless Steel Container.

 Blister Packing: Shift the inspected tablets to strip section and Strip packs them using Strip Packing Machine by operating it as per its SOP.

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by  Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

Humidity and temperature should be maintained during the compression of thermo labile products.

Sample of dried granules should be sent to Quality Control Department for the determination of Moisture content.

The total weight of blended powder should be checked in the presence of  Manufacturing Chemist and record the same in Batch Manufacturing Record.

Bulk sample should be sent for analysis to Quality Control Department before starting compression of tablets.

Weight Variation:  Intermittently weight variation of compressed tablets should be checked at 30 minutes interval by the  Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.

Out-of-limit tablets should be checked by Weight Variation Method as given below:

Take the average weight of 20 tablets on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP.

AVERAGE WEIGHT OF TABLETS
                 (in mg)		  MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
80mg or less                               10
More than 80mg and less than 250mg                                7.5
250mg or more                                 5

Take the weight of individual tablets and check if all the tablets are lying with in the limits.

Select the tablets only if no more than two tablets are out of percentage limit and if no tablet differs by more than two times the percentage limit, otherwise reject the tablets.

Adjust the desired weight of the tablets in the Compression Machine by moving weight adjustment cam clockwise or anticlockwise accordingly as per the MFR of Compression Machine.

Re-check the weight of tablets for further adjustment, if any.

Thickness of Tablets: Thickness of the tablets should be determined by means of the vernier caliper. The thickness of the tablet should be checked whenever weight adjustments are made.

Hardness of the tablets: The equipment used is the ‘Monsanto’ type hardness tester. Hardness of the compressed tablets should be checked at regular interval to determine the need for pressure adjustments on the tableting machine.

Hardness of tablets varies between: 4-6 Kg/cm2.

Friability: ‘Roche Friabilator’ is used for measuring the Friability. The instrument is designed to evaluate the ability of the tablet to withstand abrasion in packaging, handling and shipping.

Adjust the instrument to 25 RPM before adding the tablets.

Weigh 20 Tablets on calibrated balance. Transfer the tablets in the plastic chamber. Close the drum tightly.

Switch on the apparatus. Operate the Friabilator for 100 revolutions.

De-dust and reweigh the tablets. Loss in weight indicates the ability of tablets to withstand the wear.

Take 10 tablets to check the friability, when the average weight of tablet is 1g or more than 1g.

Friability Limit  = Less than 1.0%

Disintegration Test: Disintegration is the time required for the group of tablets to disintegrate into the particles. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.

The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.

Place the tablets in each of 6 tubes along with a plastic disc over the tablets.

The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.

Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.

Switch on the apparatus to move the basket assembly containing the tablets up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.

When the tablets have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the tablets and record the same in Batch Manufacturing Record.

If one or two tablets fail to disintegrate, the test is to be repeated using 12 tablets.

Disintegration Time of uncoated tablets= Not more than 15 minutes

Disintegration Time of coated tablets= Not more than 30 minutes

Tablets taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.

Inspection, sorting of rejected tablets should be done as per SOP.

The strips and cartons should be checked thoroughly for proper batch coding.

Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.

Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

Tetracycline hydrochloride I.P. 250 mg

Tablets, MASTER FORMULAS

MFR of Folic Acid Tablet

Posted on By ABHA

MFR of Folic Acid Tablet

PURPOSE:  This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

Master Copy: Manager Quality Assurance

Copy No. 1: Production Pharmacist

Copy No. 2: Manager Quality Control

Copy No. 3:  Tablet Section

PRODUCT NAME: Folic Acid TabletBATCH SIZE:  2.0 LAC
PRODUCT REFERENCE CODE: NAUNIT SIZE:  10 x 30
GENERIC NAME: FOLIC ACID TABLET B.P.PACK SIZE:  64 x 10 x 30
DOSAGE FORM: TABLETSTRENGTH: N.A.
DEPARTMENT:  TABLET DEPARTMENTEXPIRY DATE: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each uncoated Tablet contains:

Folic Acid                                       B.P.               5 mg

EQUIPMENTS TO BE USED:

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1Steam Jacketed Starch Paste Preparation Tank
2Sifter Machine
3Roto Cube Blender
4Rapid Mixer Granulator
5Multi Mill
6Fluidized Bed Drier
7Oscillating Granulator
8Sifter Machine
9Roto Cube Blender
10Tablet Compression Machine 27 Stations
11Dedusting Machine
12Tablet Inspection Machine
13.Single Track Blister Machine

RAW MATERIAL: –

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.AEROSILB.P.0.1000.100 KG
2.DI CALCIUM PHOSPHATEB.P.12.00012.000 KG
3FOLIC ACIDB.P.1.0004%1.400 KG
4LACTOSEB.P.6.0006.000 KG
5MAGNESIUM STERATEB.P.0.4000.400 KG
6SODIUM BENZOATEB.P.0.2000.200 KG
7STARCHB.P.18.00018.00 KG
8STARCHB.P.2.0002.000 KG
9STARCHB.P.7.0007.000 KG
10TALCUMB.P.0.4000.400 KG

PACKING MATERIAL:-

S.NO.NAME OF THE MATERIAL Theoretical Quantity Req.For

Record

Total Quantity Used
1. YELLOW PVC18.00018.000 KG
2.ADHESIVE TAPE ROLL BROWN1.001.00 KGS
3.ALUMINIUM FOIL4.0004.000 KGS
4UNIT CARTON666.0002.00668.000 NOS
5CELLO TAPE1.0001.000 NOS
6CORRUGATED BOX N-0811.00011.000 NOS

MANUFACTURING SPECIFICATION:

Moisture content of powder should be less than 2.0 %.

Average weight of each Tablet is 220 milligrams.

Weight Variation Limit for average weight of 20 tablets is +5 %.

Friability limit for 20 Tablets is not more than 1.0 %.

Hardness of the Tablets varies between 2 – 3 kg/cm2.

Disintegration time for each Tablet is not more than 15 minutes.

Mix the batch, compress and de-dust the tablets and also perform the primary packing of Tablets at temperature not more than 25˚C.

Yield:

Theoretical Yield is 2.0 Lac Tablets.

Expected Practical Yield is 2.0 Lac + 2% Tablets.

Packing Details:

Use PVC clear 104 mm and Aluminium foil for blister packing.

Blister Pack the inspected and De-dusted tablets by using Single Track Blister Packing Machine as per its SOP.

Put 10 strips each containing 30 tablets in each carton.

Seal each carton from both ends with cello tape.

Pack 64 cartons in specified corrugated box to give a pack size of 64 x 10 x 30 tablets.

Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

Preparation of Starch Paste:

Prepare the starch paste in the manner given below using Steam Jacketed Starch Paste Preparation Tank by operating it as per its SOP.

Dissolve 0.200 kg of Sodium Benzoate in 1Ltr of purified water and stir continuously.

Add 2.0 kg of Starch in 2 Ltrs purified water and stir continuously to make smooth slurry.

To 16 Ltrs of boiling water add previously soaked gelatin and stir continuously to form thick solution.

To this add the solution of sodium benzoate and starch slurry with constant stirring to get a uniform paste.

Sifting: Fit Stainless Steel Sieve # 100 on the Sifter-I as per its SOP. Sift Folic Acid through it and collect in Stainless Steel Container.

Fit Stainless Steel Sieve # 20 on the Sifter-I as per its SOP. Sift rest of all the ingredients through it and collect separately in Stainless Steel Containers.

Blending: Blend the following ingredients using Roto Cube Blender by operating it as per its SOP for 15 minutes and collect in Stainless Steel Container.

Starch.

Dicalcium Phosphate.

Lactose

Wet Granulation: Mix the Above blended ingredients with the Starch paste using Rapid Mixer Granulator by operating it as per its SOP. Add starch paste in such a manner by following the procedure given below so as to achieve proper wetting.

Mix the blended powder and starch paste together in Rapid Mixer Granulator.

Wet Screening: Pass the wet dough through a Multi Mill by operating it as per its SOP to convert the moist mass into coarse, granular aggregates.

Drying: Dry the granules in Fluidized Bed Drier by operating it as per its SOP at temperature 600 – 700 C for 30 minutes. Cool the granules to room temperature.

Sifting: Fit Stainless Steel Sieve # 14 on the Sifter-II as per its SOP. Sift all the granules through it and collect in Stainless Steel Container. Break the oversized granules left over the mesh in Oscillating Granulator by operating it as per its SOP and resift them.

Check the total weight of dried granules. Determine the loss on drying and percentage yield of dried

Lubrication: Lubricate the sifted granules along the following ingredients through Roto Cube Blender by operating it as per its SOP for 30 minutes and collect in Stainless Steel Container.

Aerosil

Magnesium Stearate

Starch.

Talcum

Folic Acid

Send the granules for bulk testing to Quality Control Department for assay of Active Ingredients.

Compression: Shift all the granules for compression to Tablet Compression Machine 27 Stations by operating it as per its SOP and collect the compressed tablets in Stainless Steel Container.

Tablet Inspection: Transfer the all tablets to tablet inspection machine and sort out the defected tablet by operating it as per its SOP and collect the selected tablets in Stainless Steel Container.

Blister Packing: Shift the inspected tablets to blister section and blister pack them using Single Track Blister Packing Machine by operating it as per its SOP.

IN-PROCESS CONTROLS

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

Humidity and temperature should be maintained during the compression of thermo labile products.

Sample of dried granules should be sent to Quality Control Department for the determination of Moisture content.

The total weight of blended powder should be checked in the presence of  Manufacturing Chemist and record the same in Batch Manufacturing Record.

Bulk sample should be sent for analysis to Quality Control Department before starting compression of tablets.

Weight Variation:  Intermittently weight variation of compressed tablets should be checked at 30 minutes interval by the  Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.

Out-of-limit tablets should be checked by Weight Variation Method as given below:

Take the average weight of 20 tablets on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:

AVERAGE WEIGHT OF TABLETS
                 (in mg)		  MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
80mg or less                               10
More than 80mg and less than 250mg                                7.5
250mg or more                                 5

Take the weight of individual tablets and check if all the tablets are lying with in the limits.

Select the tablets only if no more than two tablets are out of percentage limit and if no tablet differs by more than two times the percentage limit, otherwise reject the tablets.

Adjust the desired weight of the tablets in the Compression Machine by moving weight adjustment cam clockwise or anticlockwise accordingly as per the MFR of Compression Machine.

Re-check the weight of tablets for further adjustment, if any.

Thickness of Tablets:  Thickness of the tablets should be determined by means of the vernier caliper. The thickness of the tablet should be checked whenever weight adjustments are made.

Hardness of the tablets: The equipment used is the ‘Monsanto’ type hardness tester. Hardness of the compressed tablets should be checked at regular interval to determine the need for pressure adjustments on the tableting machine.

Hardness of tablets varies between: 2-4 Kg/cm2.

Friability:

‘Roche Friabilator’ is used for measuring the Friability. The instrument is designed to evaluate the ability of the tablet to withstand abrasion in packaging, handling and shipping.

Adjust the instrument to 25 RPM before adding the tablets.

Weigh 20 Tablets on calibrated balance. Transfer the tablets in the plastic chamber. Close the drum tightly.

Switch on the apparatus. Operate the Friabilator for 100 revolutions.

De-dust and reweigh the tablets. Loss in weight indicates the ability of tablets to withstand the wear.

Take 10 tablets to check the friability, when the average weight of tablet is 1g or more than 1g.

Friability Limit  = Less than 1.0%

Disintegration Test: Disintegration is the time required for the group of tablets to disintegrate into the particles. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.

The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.

Place the tablets in each of 6 tubes along with a plastic disc over the tablets.

The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.

Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is at least 2.5cm below the surface of liquid when the basket is at highest position.

Switch on the apparatus to move the basket assembly containing the tablets up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.

When the tablets have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the tablets and record the same in Batch Manufacturing Record.

If one or two tablets fail to disintegrate, the test is to be repeated using 12 tablets.

Disintegration Time of uncoated tablets= Not more than 15 minutes

Disintegration Time of coated tablets= Not more than 30 minutes

Tablets taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross contamination.

Inspection, sorting of rejected tablets should be done as per SOP.

The strips and cartons should be checked thoroughly for proper batch coding.

Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.

Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

Pantoprazole Sodium Sesquihydrate

Tablets, MASTER FORMULAS

MFR of Propranolol Hydrochloride Tablet

Posted on By ABHA

MFR of Propranolol Hydrochloride Tablet

PURPOSE:  This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

Master Copy: Manager Quality Assurance

Copy No. 1: Production Pharmacist

Copy No. 2: Manager Quality Control

Copy No. 3:  Tablet Section

PRODUCT NAME: Propranolol Hydrochloride TabletBATCH SIZE:  5.0 LAC
PRODUCT REFERENCE CODE: NAUNIT SIZE:  2 x 50
GENERIC NAME: PROPRANOLOL HYDROCHLORIDE TABLETSPACK SIZE:  20 x 10 x 2 x 50
DOSAGE FORM: TABLETSTRENGTH: N.A.
DEPARTMENT:  TABLET DEPARTMENTEXPIRY DATE: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each uncoated Tablet contains:

Propranolol Hydrochloride            B.P.                      40 mg

EQUIPMENTS TO BE USED:

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

  CLEANING

AS PER SOP NO.

1Steam Jacketed Starch Paste Preparation Tank
2Sifter Machine
3Roto Cube Blender
4Rapid Mixer Granulator
5Multi Mill
6Fluidized Bed Drier
7Oscillating Granulator
8Sifter Machine
9Roto Cube Blender
10Tablet Compression Machine 27 Stations
11Dedusting Machine
12Tablet Inspection Machine
13.Triple Track Blister Machine

RAW MATERIAL:-

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.AEROSILB.P.0.198 KG0.198 KG
2.DI  BASIC CALCIUM PHOSPHATEB.P.20.000 KG20.000 KG

 

3.ERYTHROCIN COLORF.G10.000 Gm10.000 Gm
4.LACTOSEB.P.5.000 KG5.000 KG
5.MAGNESIUM STEARATEB.P.0.450 KG0.450 KG
6.PROPANOLOL HYDROCHLORIDEB.P.20.000 KG5.00021.000 KG
7.SODIUM BENZOATEB.P.0.500 KG0.500 KG
8.STARCHB.P.35.000 KG35.000 KG
9.STARCHB.P.3.000 KG3.000 KG
10.STARCHB.P.5.000 KG5.000 KG
11.TALCUMB.P.1.485 KG1.485 KG

PACKING MATERIAL: –

S.NO.NAME OF THE MATERIAL Theoretical Quantity Req.For

Record

Total Quantity Used
1.180 MM CLEAR PVC50.00050.000 KGS
2. ALUMINIUM FOIL (HYPER TABS)8.0008.000 KGS
3.UNIT CARTONS5000.0002.005002.000 NOS
4OUTER CARTONS500.0002.00502.000 NOS
5CORRUGATED BOXES T-1025.00025.000 NOS
6CELLO TAPE1.0001.000 NO
7ADHESIVE TAPE ROLL BROWN1.0001.000 NO

MANUFACTURING SPECIFICATION:

Moisture content of powder should be less than 2.0 %.

Average weight of each Tablet is 170 milligrams.

Weight Variation Limit for average weight of 20 tablets is +5 %.

Friability limit for 20 Tablets is not more than 1.0 %.

Hardness of the Tablets varies between 2 – 4 kg/cm2.

Disintegration time for each Tablet is not more than 15 minutes.

Mix the batch, compress and de-dust the tablets and also perform the primary packing of Tablets at temperature not more than 25˚ C.

Yield:

Theoretical Yield is 5.0 Lac Tablets.

Expected Practical Yield is 5.0 Lac + 2%Tablets.

Packing Details:

Use PVC 185 mm Clear and Aluminium foil for blister packing.

Blister Pack the inspected and De-dusted tablets by using Triple Track Blister Packing Machine as per its SOP.

Put 2 strips each containing 50 tablets in each inner carton.

Put such 10 inner cartons in one outer carton.

Seal each outer carton from both ends with cello tape.

Pack 20 outer cartons in specified corrugated box to give a pack size of 20 x 10 x 2 x 50 tablets.

Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label

MANUFACTURING PROCESS:

Preparation of Starch Paste:

Prepare the starch paste in the manner given below using Steam Jacketed Starch Paste Preparation Tank by operating it as per its SOP.

Add 3.0 kg of Starch in 2 Ltr pirified Water and make slurry stir continuously.

Dissolve 0.500 kg of Sodium Benzoate in 1Ltrs of purified water.

Dissolve 10g of Erythrocin colour in 25Ltrs of hot water separately.

To this add the solution of sodium benzoate and starch slurry with constant stirring to get a uniform paste.

Sifting: Fit the Stainless Steel Sieve  # 20 on the Sifter-I as per its SOP. Sift the all ingredients through it and collect separately in Stainless Steel Container.

Blending: Blend the following ingredients using Roto Cube Blender by operating it as per its SOP for 15 minutes and collect in Stainless Steel Container.

Starch

Lactose

Di Calcium Phosphate

Propranolol Hydrochloride

Wet Granulation: Mix the Ingredients blended above with the Starch paste using Rapid Mixer Granulator by operating it as per its SOP. Add starch paste to the blended powder in a manner to achieve proper wetting by following the procedure given below:

Divide the blended powder in two equal parts.

Divide the prepared starch paste in two equal parts.

Mix the one part of blended powder and starch paste together in Rapid Mixer Granulator.

Similarly mix rest of the parts in same manner.

Wet Screening: Pass the wet dough through a Multi Mill by operating it as per its SOP to convert the moist mass into coarse, granular aggregates.

Drying: Dry the granules in Fluidized Bed Drier by operating it as per its SOP at temperature 60˚ – 70˚ C for 30 minutes. Cool the granules to room temperature.

Sifting: Fit Stainless Steel Sieve # 14 on the Sifter-II as per its SOP. Sift all granules through it and collect in Stainless Steel Container. Break the oversized granules left over the mesh in Oscillating Granulator by operating it as per its SOP. and resift them.

Check the total weight of dried granules. Determine the loss on drying and percentage yield of dried granules.

Lubrication:  Lubricate the sifted granules along the following ingredients in a Roto Cube Blender by operating it as per its SOP.Mix all the ingredients for 15 minutes and collect in Stainless Steel Containers.

Aerosil

Magnesium Stearate

Starch

Talcum

Send the granules for bulk testing to Quality Control Department for assay of Active Ingredients.

Compression:

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by  Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

Humidity and temperature should be maintained during the compression of thermolabile products.

Sample of dried granules should be sent to Quality Control Department for the determination of Moisture content.

The total weight of blended powder should be checked in the presence of  Manufacturing Chemist and record the same in Batch Manufacturing Record.

Bulk sample should be sent for analysis to Quality Control Department before starting compression of tablets.

Weight Variation: Intermittently weight variation of compressed tablets should be checked at 30 minutes interval by the Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.

Out-of-limit tablets should be checked by Weight Variation Method as given below:

Take the average weight of 20 tablets on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:

AVERAGE WEIGHT OF TABLETS
                 (in mg)		  MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
80mg or less                               10
More than 80mg and less than 250mg                                7.5
250mg or more                                 5

Take the weight of individual tablets and check if all the tablets are lying with in the limits.

Select the tablets only if no more than two tablets are out of percentage limit and if no tablet differs by more than two times the percentage limit, otherwise reject the tablets.

Adjust the desired weight of the tablets in the Compression Machine by moving weight adjustment cam clockwise or anticlockwise accordingly as per the MFR of Compression Machine.

Re-check the weight of tablets for further adjustment, if any.

Thickness of Tablets:  Thickness of the tablets should be determined by means of the vernier caliper. The thickness of the tablet should be checked whenever weight adjustments are made.

Hardness of the tablets: The equipment used is the ‘Monsanto’ type hardness tester. Hardness of the compressed tablets should be checked at regular interval to determine the need for pressure adjustments on the tableting machine.

Hardness of tablets varies between: 2-4 Kg/cm2.

Friability: ‘Roche Friabilator’ is used for measuring the Friability. The instrument is designed to evaluate the ability of the tablet to withstand abrasion in packaging, handling and shipping.

Adjust the instrument to 25 RPM before adding the tablets.

Weigh 20 Tablets on calibrated balance. Transfer the tablets in the plastic chamber. Close the drum tightly.

Switch on the apparatus. Operate the Friabilator for 100 revolutions.

De-dust and reweigh the tablets. Loss in weight indicates the ability of tablets to withstand the wear.

Take 10 tablets to check the friability, when the average weight of tablet is 1g or more than 1g.

Friability Limit  = Less than 1.0%

Disintegration Test: Disintegration is the time required for the group of tablets to disintegrate into the particles. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.

The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.

Place the tablets in each of 6 tubes along with a plastic disc over the tablets.

The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.

Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is at least 2.5 cm below the surface of liquid when the basket is at highest position.

Switch on the apparatus to move the basket assembly containing the tablets up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.

When the tablets have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the tablets and record the same in Batch Manufacturing Record.

If one or two tablets fail to disintegrate, the test is to be repeated using 12 tablets.

Disintegration Time of uncoated tablets= Not more than 15 minutes

Disintegration Time of coated tablets= Not more than 30 minutes

Tablets taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.

Inspection, sorting of rejected tablets should be done as per SOP.

The strips and cartons should be checked thoroughly for proper batch coding.

Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.

Intimation should be sent to Quality Control Department for finished product sampling and testing.

After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.

Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

Tetracycline hydrochloride I.P. 250 mg

Tablets, MASTER FORMULAS

Nimesulide B.P.100 mg

Posted on By ABHA

Nimesulide B.P. 100 mg

PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE:  This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

  1. Master Copy : Manager Quality Assurance
  2. Copy No. 1 : Production Pharmacist
  3. Copy No . 2 : Manager Quality Control
  4. Copy No .  3 :  Non-β Lactam Capsule Section

PRODUCT NAME: Nimesulide B.P. 100 mg

BATCH SIZE:  3.0 LAC
PRODUCT REFERENCE CODE: UNIT SIZE:  20 ´ 10
GENERIC NAME: NIMESULIDE & DICLOFENAC SODIUM CAPSULESPACK SIZE:  60 ´ 20 ´ 10
DOSAGE FORM: CAPSULESTRENGTH: N.A.
DEPARTMENT:  NON β-LACTAM DEPARTMENTEXPIRY DATE:  AFTER 24 MONTHS   FROM THE DATE OF MANUFACTURING

    COMPOSITION:

Each Capsules contains:

Nimesulide                       B.P.    100 mg

    Diclofenac Sodium           I.P.       50 mg

  EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Tray Drier Machine
2 Sifter
3Roto Cube Blender
4Automatic Capsule Loading Machine
5Semiautomatic Capsule Filling  Machine
6Feeder, Sorter & Capsule Polishing Machine With A.D.U.
7Triple Track Blister Packing Machine

RAW MATERIALS:

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1AEROSILB.P.0.6000.600 KGS
2DI CALCIUM PHOSPHATEI.P.7.5007.500 KGS
3DICLOFENAC SODIUMI.P.15.00015.000 KGS
4EMPTY CAPSULES

GREY / YELLOW  (SIZE: 2)

–30000.00030000.000 NOS
5MAGNESIUM STEARATEI.P.2.4002.400 KGS
6NIMESULIDEB.P.30.00030.000 KGS
7STARCHI.P.19.80019.800 KGS
8TALCUMI.P.4.5004.500 KGS

Packing Material:

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1.78 MM CLEAR (PVC)42.00042.000 KGS
2ADHESIVE TAPE ROLL BROWN1.0001.000 NOS
3CELLO TAPE3.0003.000 NOS
4ALUMINIUM FOIL9.0009.000 KGS
5UNIT CARTON  (20 X 10)1500.0002.0001502.000 NOS
6CORRUGATED BOX S – 11 (K-13)25.00025.000 NOS

MANUFACTURING SPECIFICATION:

  1. Use number two size Gray/Yellow
  2. Moisture content of powder should be less than 2.0 %.
  3. Average fill of each capsule is 260 milligrams.
  4. Weight Variation Limit for average weight of 20 Capsules is +5 %
  5. Disintegration time for each Capsule is not more than 15 minutes.
  6. Average weight of twenty filled capsules is 6.4 grams.
  7. Mix the batch, Fill and Polish the Capsules and also perform the primary packing of Capsules at temperature not more than 270 C and Relative Humidity not more than 45 %.

      Yield:

  1. Theoretical Yield is 3.0 Lac capsules.
  2. Expected Practical Yield is 3.0 Lac ± 2% capsules.

      Packing Details:

  1. Blister Pack the filled and polished capsules by using Triple Track Blister Packing Machine as per its
  2. Put 20 strips each containing 10 capsules in carton.
  3. Seal the unit carton from both ends with cello tape.
  4. Pack the 60 unit cartons in specified corrugated boxes S-11 to give a pack size of 60 x 20 x 10 capsules.
  5. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label

MANUFACTURING PROCESS:

  1. Fit the mesh # 20 Stainless Steel Sieve on the Sifter as per its SOP  and place Stainless Steel Container below the discharge hopper.
  2. Sift the 0.600 kgs of Aerosil through 20 mesh Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.
  3. Sift the 7.5 kgs of Di-Calcium Phosphate through 20 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  4. Sift the 15.0 kgs of Diclofenac Sodium through 20 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  5. Sift the 2.4 kgs of Magnesium Stearate through 20 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  6. Sift the 4.5 kgs of Talcum through 20 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  7. Sift the 30.0 kgs of Nimesulide through 20 mesh Stainless Steel Sieve on the sifter and collect it in another stainless steel container.
  8. Transfer all the ingredients sifted to Roto Cube Blender. Mix 18 kgs of Calcium Sulphate granules to these ingredients and allow to blend together for 1 hour by operating, Roto cube Blender as per its SOP Weigh the whole batch. The weight of blended powder should be in range of 77.220 kg – 78.00 kg.
  9. Send the sample to Quality Control Department for bulk testing.
  10. Start filling of Empty Hard Gelatin capsules, 260 miligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP 
  11. Polish the filled capsules by using Feeder, Sorter & Capsule Polishing Machine With A.D.U. as per its SOP 
  12. Blister pack the filled and polished capsules by using Triple Track Blister Packing Machine as per its SOP 

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

  1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  2. All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
  3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  4. Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.
  • Relative Humidity –   Less than 45 %
  • Temperature –   25 0C ± 2 0C
  1. The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
  2. Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.
  3. Intermittently the Assistant Manufacturing Chemist should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
  4. Detect out of limit capsules by Weight Variation Method as follows:
  5. a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP
AVERAGE WEIGHT OF CAPSULES
(in mg)		MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
Less than 300 mg10
300 mg or More7.5

b) Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.

c) Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.

  • Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.
  • Inspection, sorting and polishing of filled capsules should be done as per SOP 
  • Disintegration of filled capsules should be done using Disintegration Testing Apparatus.
  • Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.
  • The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.
  • Place the capsules in each of 6 tubes along with a plastic disc over the capsules.
  •  The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the t
  • Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.
  • Switch on the apparatus to move the basket assembly containing the capsules up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.
  • When the capsules have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the capsules and record the same in Batch Manufacturing Record.
  • Disintegration Time of filled capsules = Not more than 15 minutes
  • The strips and cartons should be checked thoroughly for proper batch coding.
  • Assistant Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.
  • Intimation should be sent to Quality Control Department for finished product sampling and testing.
  • After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.
  • It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.
  • Filling or packaging of next product should not commence until the Quality Control Analyst has given the ‘Line Clearance’.
  • Other related Post:Glucosamine Sulphate 500mg
Capsules, MASTER FORMULAS

Ferrous Fumerate I.P. 300 mg

Posted on By ABHA

Ferrous Fumerate I.P. 300 mg

PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

  • Master Copy : Manager Quality Assurance
  • Copy No. 1 : Production Pharmacist
  • Copy No. 2 : Manager Quality Control
  • Copy No.  3 :    Non-β Lactam Capsule Section
    PRODUCT NAME:Ferrous Fumerate I.P. 300 mgBATCH SIZEz:  1.0 LAC
    PRODUCT REFERENCE CODE: UNIT SIZE:  10 ´ 30
    GENERIC NAME: N.A.PACK SIZE:  36 ´ 10 ´ 30
    DOSAGE FORM: CAPSULESTRENGTH: N.A.
    DEPARTMENT:  NON β-LACTAM DEPARTMENTEXPIRY DATE:  AFTER 18 MONTHS   FROM THE DATE OF MANUFACTURING

      COMPOSITION:

Each Capsule contains:

Ferrous Fumerate            I.P.   300 mg

Folic Acid                         I.P.     1.5 mg

Vitamin B12                    I.P.     10 mcg

Calcium Carbonate          I.P.    200 mg

EQUIPMENTS TO BE USED:

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Tray Drier Machine
2 Sifter
3Roto Cube Blender
4Automatic Capsule Loading Machine
5Semiautomatic Capsule Filling Machine
6Feeder, Sorter & Capsule Polishing Machine With A.D.U.
7A.D.U.
8Triple Track Blister Packing Machine

Raw materials:

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.AEROSILB.P.0.0800.080KGS
2CALCIUM CARBONATEI.P.20.00010.0022.000 KGS
3EMPTY CAPSULES

GREEN / GREEN (0)

–100000.000100000.000 NOS
4FOLIC ACIDI.P.0.15050.000.225 KGS
5FERROUS FUMERATEI.P.30.0005.0031.500 KGS
6MAGNESIUM STEARATEI.P.0.6000.600 KGS
7SPIRIT CHLOROFORMI.P.0.450 ML0.450 ML
8STARCHI.P.4.0004.000 KGS
9TALCUMI.P.1.6001.600 KGS
10VITAMIN B – 12I.P.1.000100.002.000 GMS

 Packing Material:

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1220 MM DARK GREEN (PVC)18.00018.000 KGS
2ADHESIVE TAPE ROLL BROWN1.0001.000 NOS
3CORRUGATED BOXEX   B – 159.2599.259 NOS
4ALUMINIUM FOIL  (3 TRACK)4.0004.000 KGS
5CELLO TAPE1.0001.000 NOS
6UNIT CARTON (10 X 30)333.3332.000335.333 NOS

MANUFACTURING SPECIFICATION:

  1. Use number zero size Green-Green Capsules.
  2. Moisture content of powder should be less than 2.0 %.
  3. Average fill of each capsule is 600 milligrams.
  4. Weight Variation Limit for average weight of 20 Capsules is +5 %
  5. Disintegration time for each Capsule is not more than 15 minutes.
  6. Average weight of twenty filled capsules is 13.9 grams.
  7. Mix the batch, Fill and Polish the Capsules and also perform the primary packing of Capsules at temperature not more than 270 C and Relative Humidity not more than 45 %.

Yield:

Theoretical Yield is 1.0 Lac capsules.

Expected Practical Yield is 1.0 Lac ± 2% capsules.

Packing Details:

  1. Blister Pack the filled and polished capsules by using Triple Track Blister Packing Machine as per its SOP 
  2. Put 10 strips each containing 30 capsules in carton.
  3. Seal the unit carton from both ends with cello tape.
  4. Pack the 36 unit cartons in specified corrugated box B-15 to give a pack size of 36 x 10 x 30 capsules.
  5. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS: 

  • Fit the mesh # 40 Stainless Steel Sieve on the Sifter as per its SOP  and place Stainless Steel Container below the discharge hopper.
  • Sift the 0.080 kgs of Aerosil through 40 mesh Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.
  • Sift the 22 kgs of Calcium Carbonate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  • Sift the 0.225 kgs of Folic Acid through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  • Sift the 31.5 kgs of Ferrous Fumerate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  • Sift the 0.600 kgs of Magnesium Stearate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  • Triturate and dissolve 2.0 Gms of Vitamin B12 in 450 ml of Spirit Chloroform in a stainless steel container.
  • Sift the 1.600 kgs of Talcum through 40 mesh Stainless Steel Sieve on the sifter and collect it in another stainless steel container.
  • To this add solution of vitamin B12 prepared in step no. 7 and mix it thoroughly with stainless steel spatula until uniform.
  • Dry it in the tray dryer at 60° C for 30 minutes.
  • Sieve it through 40 mesh and add to the Roto Cube Blender.
  • Transfer all the sifted ingredients to Roto Cube Blender. Mix 4.000 kgs of Calcium Sulphate granules to these ingredients and allow blending together for 1 hour by operating Roto Cube Blender as per its SOP Weigh the whole batch. The weight of blended powder should be in range of 59.41 kg – 60.0 kg.
  • Send the sample to Quality Control Department for bulk testing.
  • Start filling of Empty Hard Gelatin capsules, 600 miligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP
  • Polish the filled capsules by using Feeder, Sorter & Capsule Polishing Machine with A.D.U. as per it SOP

Blister pack the filled capsules by using Triple Track Blister Packing Machine as per its SOP

IN-PROCESS CONTROLS:

 The following in-process controls should be maintained during the processing:

  • Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  • All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
  • Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  • Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.
  • Relative Humidity –   Less than 45 %
  • Temperature –   25 0C ± 2 0C

The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.

Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.

  • Intermittently the Assistant Manufacturing Chemist should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
  • Detect out of limit capsules by Weight Variation Method as follows:
  • a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP
AVERAGE WEIGHT OF CAPSULES
(in mg)		MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
less than 300 mg10
300 mg or More7.5
  • b) Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.
  • c) Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.
  • Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.
  • Inspection, sorting and polishing of filled capsules should be done as per SOP 
  • Disintegration of filled capsules should be done using Disintegration Testing Apparatus.
  •  Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.
  • The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.
  •  Place the capsules in each of 6 tubes along with a plastic disc over the capsules.
  •  The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.

Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each

  • tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.
  •  Switch on the apparatus to move the basket assembly containing the capsules up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.
  • When the capsules have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the capsules and record the same in Batch Manufacturing Record.
Disintegration Time of filled capsules = Not more than 15 minutes
  • The strips and cartons should be checked thoroughly for proper batch coding.
  • Assistant Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.
  • Intimation should be sent to Quality Control Department for finished product sampling and testing.
  • After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.
  • It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.
  • Filling or packaging of next product should not commence until the Quality Control Analyst has given the ‘Line Clearance’.
  • Other relaed post:Lansoprazole 30 mg

 

Capsules, MASTER FORMULAS

Lansoprazole U.S.P.30 mg

Posted on By ABHA

Lansoprazole U.S.P. 30 mg

PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY:It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

  • Master Copy : Manager Quality Assurance
  • Copy No. 1 : Production Pharmacist
  • Copy No. 2 : Manager Quality Control

Copy No. 3 : Non-β Lactam Capsule Section

PRODUCT NAME: Lansoprazole U.S.P. 30 mgBATCH SIZE:  1.0 LACS
PRODUCT REFERENCE CODE: UNIT SIZE:  10 ´ 10
GENERIC NAME: LANSOPRAZOLE AND

DOMPERIDONE CAPS

PACK SIZE:  50 ´ 10 ´ 10
DOSAGE FORM: CAPSULESTRENGTH: N.A.
DEPARTMENT:  NON β-LACTAM DEPARTMENT

EXPIRY DATE:  AFTER 18 MONTHS   FROM THE DATE OF MANUFACTURING

           COMPOSITION:

           Each Capsule contains:

Lansoprazole                       U.S.P.          30 mg

(As enteric coated pallets)

Domperidone Maleate             B.P.

Equivalent to Domperidone                     10 mg

           (As enteric coated pallets)

 EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Sifter 
2Roto Cube Blender 
3Automatic Capsule Loading Machine 
4Semiautomatic Capsule Filling Machine 
5Feeder, Sorter & Capsule Polishing Machine With A.D.U. 
6Blister Packing Machine

RAW MATERIALS: 

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.EC SKY BLUE / SKY BLUE

(SIZE: 2)

–100000.000100000.00 NOS
2.LACTOSEB.P.2.2502.250 KGS
3.LANSOPRAZOLE PELLETS 15%U.S.P.21.00021.000 KGS
4.DOMPERIDONE PELLETS 40%B.P.2.7502.750 KGS

Packing Material

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1.ADHESIVE TAPE ROLL BROWN1.0001.000 NOS
2.CELLO TAPE4.0004.000 NOS
3.LANSOMAC CAPS (INSERTS)10000.00010000.000 NOS
4.UNIT CARTON (10 CAPS)

 

10000.0002.00010002.000 nos
5.OUTER CARTON (10 X10 CAPS)

 

            1000.0002.0001002.000 NOS
6.78 MM CLEAR PVC

 

22.00015.000 KGS
7.ALUMINIUM BLISTER FOIL22.0003.500 KGS
8.CORRUAGED BOX  N – 2042.00042.000 NOS

MANUFACTURING SPECIFICATION:

  1. Use number 2 size Sky Blue / Sky Blue Capsules.
  2. Moisture content of granules should be less than 2.0 %.
  3. Average fill of each capsule is 260 mg.
  4. Weight Variation Limit for average weight of 20 Capsules is +5 %
  5. Disintegration time for each Capsule is not more than 15 minutes.
  6. Average weight of twenty filled capsules is 6.440 grams.
  7. Since Omeprazole is photo sensitive, all primary operations such as Batch Mixing, Filling, sorting and strip packing of Omimac capsule should be carried out in darkness and direct exposure to light should be avoided.
  8. Temperature of primary area NMT 27° C and RH not more than 45%.

      Yield:

  1. Theoretical Yield is 1.0 Lac capsules.
  2. Expected Practical Yield is 1.0 Lac ± 2% capsules.

Packing Details:

  1. Blister Pack the filled and polished capsules by using Strip Packing Machine as per its SOP 
  2. Put single strip each containing 10 capsules into the unit carton.
  3. Put such 10 strips packed in unit carton each containing 10 capsules into the outer carton.
  4. Seal the outer carton from both ends with cello tape.
  5. Pack the 50 outer cartons in specified corrugated box N-20 to give a pack size of 50 x 10 x 10 capsules.
  6. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label

MANUFACTURING PROCESS:

 

  1. Transfer 21.000 kg of Lansoprazole pellets to Roto Cube Blender.
  2. Transfer 2.750 kg of Domperidone 2.250 kg of prepared Lactose granules to Roto Cube Blender and blend for 15 minutes by operating Roto Cube Blender as per SOP No. SOP/NB/003/MO/II.
  3. Weigh the whole batch. The weight of whole batch should be in range of 25.740 kg – 26.0 kg.
  4. Send the sample to Quality Control Department for bulk testing.
  5. Start filling of Empty Hard Gelatin capsules, 260 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP
  6. Sort the filled capsules by using Feeder, Sorter unit of Feeder, Sorter & Capsule Polishing Machine with A.D.U. as per its SOP
  7. Blister pack the filled capsules by using Strip Packing Machine as per its SOP 

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

  1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  2. All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
  3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  4. Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.
  • Relative Humidity –   Less than 45 %
  • Temperature –   25 0C ± 2 0C
  1. The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
  2. Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.
  3. Intermittently the Assistant Manufacturing Chemist should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
  4. Detect out of limit capsules by Weight Variation Method as follows:
  5. a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:

 

AVERAGE WEIGHT OF CAPSULES
(in mg)		MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
Less than 300 mg10
300 mg or More7.5
  • Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.
  • c) Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.
  • Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.
  • Inspection, sorting and polishing of filled capsules should be done as per SOP NO. SOP/NB/007/PG/II.
  • Disintegration of filled capsules should be done using Disintegration Testing Apparatus.
  • i) Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.
  • ii) The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.
  • iii) Place the capsules in each of 6 tubes along with a plastic disc over the capsules.
  • iv) The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.
  • v) Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.
  • vi) Switch on the apparatus to move the basket assembly containing the capsules up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.
  • vii) When the capsules have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the capsules and record the same in Batch Manufacturing Record.
  • Disintegration Time of filled capsules = Not more than 15 minutes
  • The strips and cartons should be checked thoroughly for proper batch coding.
  • Assistant Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.
  • Intimation should be sent to Quality Control Department for finished product sampling and testing.
  • After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach
  • the same in the Batch Manufacturing Record.
  • It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.
  • Filling or packaging of next product should not commence until the Quality Control Analyst has given the ‘Line Clearance’.
  • Other related Post:NORFLOXACIN & LOPERAMIDE CAPSULE
Capsules, MASTER FORMULAS

Vitamin with Ginseng 200 mg Capsules

Posted on By ABHA

Ginseng Powder 200 mg

PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

  • Master Copy : Manager Quality Assurance
  • Copy No. 1 : Production Pharmacist
  • Copy No. 2 : Manager Quality Control
  • Copy No. 3 : Non-β Lactam Capsule Section
PRODUCT NAME:Vitamin with Ginseng 200 mg CapsulesBATCH SIZE:  1.0 LAC
PRODUCT REFERENCE CODE: NAUNIT SIZE: 5 X 10
GENERIC NAME: N.A.PACK SIZE:  80 ´ 5 ´ 10
DOSAGE FORM: CAPSULESTRENGTH: N.A.
DEPARTMENT:  NON β-LACTAM DEPARTMENTEXPIRY DATE:  AFTER 12 MONTHS   FROM THE DATE OF MANUFACTURING

COMPOSITION:

 Each Capsule contains:

  Ginseng Powder               J.P.     200    mg                                Vitamin C                                       I.P.           50 mg

Vitamin A (as Acetate)                 2500 I.U.                                Vitamin E                                       I.P.            10 mg

     Cholecalciferol                  I.P.      200 I.U.                                  (as Alpha Tocopheryl Acetate)

     Thiamine Mononitrate      I.P.       2 mg                                      Dibasic Calcium Phosphate           I.P.            25 mg

     Riboflavin                         I.P.       2 mg                                      Dried Ferrous Sulphate                  I.P.            30 mg

Niacinamide                     I.P.       25 mg                                    Magnesium Oxide Light                 I.P.            10 mg

     Pyridoxine HCl                 I.P.       1.5   mg                                 Manganese Sulphate                     I.P.              2 mg

     Calcium Pantothenate     I.P.        5   mg                                   Copper Sulphate                            I.P.              1 mg

     Folic Acid                         I.P.        0.1 mg                                  Zinc Sulphate                                 I.P.              1 mg

Vitamin B12                      I.P.        1 mcg

 EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Tray Drier Machine 
2 Sifter 
3Roto Cube Blender 
4Automatic Capsule Loading Machine 
5Semiautomatic Capsule Filling Machine 
6Feeder, Sorter & Capsule Polishing Machine With A.D.U. 
7Triple Track Blister Packing Machine

RAW MATERIALS: 

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1AEROSILB.P.0.1000.100 KGS
2COPPER SULPHATEI.P.0.10020.000.120 KGS
3DI CALCIUM PHOSPHATEI.P.2.50010.002.750 KGS
4CALCIUM PANTOTHENATEI.P.0.50010.000.550 KGS
5DRIED FERROUS SULPHATEI.P.3.00010.003.300 KGS
6EDTAI.P.0.1000.100 KGS
7E.C. Black\Black (Size:0)

BLACK / BLACK (0)

–100000.000100000.000 KGS
8FOLIC ACIDI.P.0.01050.000.015 KGS
9GINSING POWDERJ.P.20.00020.000 KGS
10MAGANESE SULPHATEI.P.0.20020.000.240 KGS
11MAGNESIUM OXIDE LIGHTI.P.1.0005.001.050 KGS
12NIACINAMIDEI.P.2.50010.002.750 KGS
13SODIUM BENZOATEI.P.0.1700.170 KGS
14S.M.B.SI.P0.1000.100 KGS
15SPIRIT CHLOROFORMI.P.0.450 ML0.450 ML
16STARCHI.P.5.0005.000 KGS
17VITAMIN A – ACETATE POW.–0.50015.000.575 KGS
18VITAMIN – B2 (PLAIN)I.P.0.20020.000.240 KGS
19VITAMIN – B1 (MONO NITRATE)I.P.0.20020.000.240 KGS
20VITAMIN – B6 HClI.P.0.15020.000.180 KGS
21VITAMIN – C (COATED0I.P.5.00010.005.500 KGS
22VITAMIN – D3I.P.0.50050.000.750 GMS
23VITAMIN – B12I.P.0.100100.000.200 GMS
24VITAMIN – E (COATED – 50%)I.P.1.000140.002.400 KGS
25ZINC SULPHATEI.P.0.10020.000.120 KGS

Packing materials:

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1225 MM CLEAR PVC50.00050.000 KGS
2ADHESIVE TAPE ROLL  BROWN1.0001.000 NOS
3CELLO TAPE4.0004.000 NOS
4CORRUGATED BOX  K -1325.00025.000 NOS
5OUTER CARTON2000.0002.0002002.000 NOS
6ALUMINIUM FOIL10.00010.000 KGS

MANUFACTURING SPECIFICATION:

Use number zero size Black – Black Capsules.

Moisture content of powder should be less than 2.0 %.

Average fill of each capsule is 455 milligrams.

Weight Variation Limit for average weight of 20 Capsules is +5 %

Disintegration time for each Capsule is not more than 15 minutes.

Average weight of twenty filled capsules is 11.0 grams.

Mix the batch, Fill and Polish the Capsules and also perform the primary packing of Capsules at temperature not more than 270 C and Relative Humidity not more than 45 %.

Yield:

Theoretical Yield is 1.0 LAC capsules.

Expected Practical Yield is 1.0 LAC ± 2% capsules

Packing Details:

Blister Pack the filled and polished capsules by using Blister Packing Machine as per its

Put 5 strips each containing 10 capsules into the carton.

Seal the unit carton from both ends with cello tape.

Pack the 80 unit cartons in specified corrugated box K-13 to give a pack size of 80 x 5 x 10 capsules.

Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label

MANUFACTURING PROCESS: 

Fit the mesh # 40 Stainless Steel Sieve on the Sifter as per its SOP  and place Stainless Steel Container below the discharge hopper.

Sift the 0.100 kgs of Aerosil through 40 mesh Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.

Dry 0.120 kgs of Copper Sulphate in tray drier at 60°C for 45 minutes and sift it through 40 mesh Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.

Sift the 0.550 kgs of Calcium Pantothenate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 3.300 kgs of Dried Ferrous Sulphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 0.100 kgs of EDTA through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 0.015 kgs of Folic Acid through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 20.0 kgs of Ginseng Powder through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 3.300 kgs of Dried Ferrous Sulphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 0.240 kgs of Manganese Sulphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 1.050 kgs of Magnesium Oxide Light through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Dry 2.750 kgs of Niacinamide in tray drier at 60°C for 45 minutes and sift it through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 0.170 kgs of Sodium Benzoate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 0.100 kgs of Sodium Meta bi-sulphite through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container

Sift the 0.240 kgs of Vitamin B1 Mono Nitrate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift 0.240 kg of Vitamin B2 through 40 mesh and collect in same container.

Sift the 0.180 kgs of Vitamin B6 HCl through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 5.50 kgs of Vitamin C Coated through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 0.575 kgs of Vitamin – A Acetate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 2.4 kgs of Vitamin E (coated 50%) through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Sift the 0.120 kgs of Zinc Sulphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.

Triturate and dissolve 0.200 Gms of Vitamin B12 in 225ml of spirit chloroform in a stainless steel container.

Similarly dissolve 0.750 gm of Vitamin D3 in 225 ml of spirit chloroform in a stainless steel container

Sift 2.750 kgs of D.C.P. through 40 mesh Stainless Steel Sieve on the sifter and collect it in another stainless steel container and perform the following:

To this add the solution of Vitamin B12 prepared in the step no. 23 and mix it thoroughly with a stainless steel spatula until uniform.

Also add the solution of Vitamin D3 prepared in the step no. 24 and mix it thoroughly with a stainless steel spatula until uniform.

Dry it in the tray drier at 60°C for 30 minutes.

Sieve it through 40 mesh and add to the Roto Cube Blender.

Transfer all the sifted ingredients to Roto Cube Blender. Mix 5.0 kg of Calcium Sulphate granules to these ingredients and blend it together for 1 hour by operating it as per its SOP

Weigh the whole batch. The weight of whole batch should be in range of 43.230 kg – 45.50

Send the sample to Quality Control Department for bulk testin

Start filling of Empty Hard Gelatin capsules, 455 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP

Polish the filled capsules by using Feeder, Sorter & Capsule Polishing Machine with A.D.U. as per its
SOP 

Blister pack the filled capsules by using Triple Track Blister Packing Machine as per its SOP .

IN-PROCESS CONTROLS: 

The following in-process controls should be maintained during the processing:

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.

Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.

Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.

Relative Humidity –   Less than 45 %

Temperature –   25 0C ± 2 0C

The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.

Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.

Intermittently the Assistant Manufacturing Chemist should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.

Detect out of limit capsules by Weight Variation Method as follows:

The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.

Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:

Detect out of limit capsules by Weight Variation Method as follows:

a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:

 

AVERAGE WEIGHT OF CAPSULES
(in mg)		MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
less than 300 mg10
300 mg or More7.5

Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.

Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.

Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and  cross-contamination.

Inspection, sorting and polishing of filled capsules should be done as per SOP 

Disintegration of filled capsules should be done using Disintegration Testing Apparatus.

Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.

The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.

Place the capsules in each of 6 tubes along with a plastic disc over the capsules.

Other related Post:Lactobacillus Sporogenes Diastase 25 mg 

Capsules, MASTER FORMULAS

NORFLOXACIN & LOPERAMIDE CAPSULE

Posted on By ABHA

NORFLOXACIN & LOPERAMIDE CAPSULE

PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE: This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

  • Master Copy : Manager Quality Assurance
  • Copy No. 1 : Production Pharmacist
  • Copy No. 2 : Manager Quality Control
  • Copy No. 3 : Non-β Lactam Capsule Section
PRODUCT NAME: Norfloxacin Tablets IP 200 mgBATCH SIZE:  1.0 LAC
PRODUCT REFERENCE CODE: UNIT SIZE: 10 ´ 10
GENERIC NAME: PACK SIZE:  21 ´ 10 ´ 10
DOSAGE FORM: CAPSULESTRENGTH: N.A.
DEPARTMENT:  NON β-LACTAM DEPARTMENTEXPIRY DATE:  AFTER 24 MONTHS   FROM THE DATE OF MANUFACTURING

 COMPOSITION:

   Each Capsule contains:

   Norfloxacin                             I.P.         200 mg

   Loperamide HCl                     I.P.             2 mg

EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Tray Drier Machine 
2 Sifter 
3Roto Cube Blender 
4Automatic Capsule Loading Machine 
5Semiautomatic Capsule Filling Machine 
6Feeder, Sorter & Capsule Polishing Machine With A.D.U. 
7Strip packing Machine

RAW MATERIALS: 

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.AEROSILI.P.0.0650.065 KGS
2DI CALCIUM PHOSPHATEI.P.3.7503.750 KGS
3EC SCARLET / SCARLET

(SIZE : 2)

–100000.000100000.000 NOS
4LOPERAMIDE HClI.P.0.2005.000.210 KGS
5MAGNESIUM STEARATEI.P.1.3351.335 KGS
6NORFLOXACINI.P.20.0005.0021.000 KGS
7TALCUMI.P.1.6501.650 KGS

Packing Material:

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1ADHESIVE TAPE ROLL BROWN1.0001.000 NOS
2CELLO TAPE2.0002.000 NOS
3CORRUGED BOX47.00047.000 NOS
4UNIT CARTON1000.0002.0001002.000
5STRIP FOIL (FRONT)23.00023.000 KGS
6STRIP FOIL (BACK)23.00023.000 KGS

MANUFACTURING SPECIFICATION:

  1. Use number two size Scarlet – Scarlet Capsules.
  2. Moisture content of powder should be less than 2.0 %.
  3. Average fill of each capsule is 280 milligrams.
  4. Weight Variation Limit for average weight of 20 Capsules is +5 %
  5. Disintegration time for each Capsule is not more than 15 minutes.
  6. Average weight of twenty filled capsules is 6.8 grams.
  7. Mix the batch, Fill and Polish the Capsules and also perform the primary packing of Capsules at temperature not more than 270 C and Relative Humidity not more than 45 %.

Yield:

  1. Theoretical Yield is 1.0 LAC capsules.
  2. Expected Practical Yield is 1.0 LAC ± 2% capsules.

Packing Details:

  1. Strip Pack the filled and polished capsules by using Strip Packing Machine as per its SOP
  2. Put 10 strips each containing 10 capsules into the carton.
  3. Seal the unit carton from both ends with cello tape.
  4. Pack the 21 unit cartons in specified corrugated box N-08 to give a pack size of 21 x 10 x 10 capsules.
  5. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS: 

  1. Fit the mesh # 40 Stainless Steel Sieve on the Sifter as per its SOP and place Stainless Steel Container below the discharge hopper.
  2. Sift the 0.065 kgs of Aerosil through 40 mesh Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.
  3. Sift the 4.750 kgs of Di-Calcium Phosphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  4. Sift the 0.200 kgs of Loperamide HCl through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  5. Sift the 1.335 kgs of Magnesium Stearate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  6. Sift the 1.650 kgs of Talcum through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  7. Sift the 20.0 kgs of Norfloxacin through 40 mesh Stainless Steel Sieve on the sifter and collect in the separate container.
  8. Transfer all the sifted ingredients to Roto Cube Blender and blend together for 1 hour by operating it as
    per its SOP .
  9. Weigh the whole batch. The weight of whole batch should be in range between 27.720 kg – 28.0 kg.
  10. Send the sample to Quality Control Department for bulk testing.
  11. Start filling of Empty Hard Gelatin capsules, 280 miligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP 
  12. Polish the filled capsules by using Feeder, Sorter & Capsule Polishing Machine With A.D.U. as per its
    SOP 
  13. Strip pack the filled capsules by using Strip Packing Machine as per its SOP 

IN-PROCESS CONTROLS: 

The following in-process controls should be maintained during the processing:

  1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  2. All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
  3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  4. Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.
  • Relative Humidity –   Less than 45 %
  • Temperature –   25 0C ± 2 0C
  1. The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
  2. Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.
  3. Intermittently the Assistant Manufacturing Chemist should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
  4. Detect out of limit capsules by Weight Variation Method as follows:
  5. Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:
AVERAGE WEIGHT OF CAPSULES
(in mg)		MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
less than 300 mg10
300 mg or More7.5
  •  Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.
  •  Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and  cross-contamination.
  • Inspection, sorting and polishing of filled capsules should be done as per SOP 
  • Disintegration of filled capsules should be done using Disintegration Testing Apparatus
  • Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.
  • The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.
  •  Place the capsules in each of 6 tubes along with a plastic disc over the capsules
  •  The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.
  • Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.
  •  Switch on the apparatus to move the basket assembly containing the capsules up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.
  • When the capsules have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the capsules and record the same in Batch Manufacturing Record.
  • Disintegration Time of filled capsules = Not more than 15 minutes
  • The strips and cartons should be checked thoroughly for proper batch coding.
  • Assistant Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.
  • Intimation should be sent to Quality Control Department for finished product sampling and testing.
  • After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.
  • It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.
  • Filling or packaging of next product should not commence until the Quality Control Analyst has given the ‘Line Clearance’.
  • Other related Post:Omeprazole 40 mg
Capsules, MASTER FORMULAS

Fungal Diastase I.P 50mg

Posted on By ABHA

Fungal Diastase I.P 50mg

PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE:   This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

  1. Master Copy : Manager Quality Assurance
  2. Copy No. 1 : Production Pharmacist
  3. Copy No. 2 : Manager Quality Control
  4. Copy No. 3 : Non-β Lactam Capsule Section
PRODUCT NAME: N–ZYME CAPSULESBATCH SIZE:  3.0 LACS
PRODUCT REFERENCE CODE:UNIT SIZE:  10 ´ 10
GENERIC NAME: N.A.PACK SIZE:  60 ´ 10 ´ 10
DOSAGE FORM: CAPSULESTRENGTH: N.A.
DEPARTMENT:  NON β-LACTAM DEPARTMENTEXPIRY DATE:  AFTER 12 MONTHS FROM THE DATE OF MANUFACTURING

    COMPOSITION:

     Each Capsule contains:

Fungal Diastase (1:1200)      I.P.     50 mg

     Papain (1:3000)                     I.P.     10 mg

Simethicone                           I.P.     50 mg

EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Tray Drier Machine 
2 Sifter 
3Roto Cube Blender 
4Automatic Capsule Loading Machine 
5Semiautomatic Capsule Filling Machine 
6Feeder, Sorter & Capsule Polishing Machine With A.D.U. 
7Strip Packing Machine

RAW MATERIALS:

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1AEROSILB.P0.9000.900 KGS
2DI CALCIUM PHOSPHATEI.P.115.000115.000 KGS
3EC SCARLET / SCARLET

(SIZE : 0)

–30000.000300000.000 KGS
4FUNGAL DIASTASEI.P.9.00075.0015.750 KGS
5MAGNESIUM STEARATEI.P.1.8001.800 KGS
6PEPSINI.P.3.00075.005.250 KGS
7SIMETHICONEI.P.15.0005.0015.750 KGS
8TALCUMI.P.1.8001.800 KGS

PACKING MATERIALS:

 

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1ADHESIVE TAPE ROLL BROWN1.0001.000 NOS
2CORRUGATED BOX  B -1550.00050.000 NOS
3CELLO TAPE3.0003.000 NOS
4UNIT CARTON ( 10 X 10)3000.0002.003002.000 NOS
5STRIP FOIL  (FRONT)69000.00069000.000 KGS
6STRIP FOIL (BACK)69000.00069000.000 KGS

MANUFACTURING SPECIFICATION:

  1. Use Zero size Scarlet /Scarlet Capsules.
  2. Moisture content of powder should be less than 2.0 %.
  3. Average fill of each capsule is 521 mg.
  4. Weight Variation Limit for average weight of 20 Capsules is +5 %
  5. Disintegration time for each Capsule is not more than 15 minutes.
  6. Average weight of twenty filled capsules is 12.34 grams.
  7. Mix the batch, Fill and Polish the Capsules and also perform the primary packing of Capsules at temperature not more than 270 C and Relative Humidity not more than 45%

Yield:

Theoretical Yield is 3.0 LAC capsules.

Expected Practical Yield is 3.0 LAC ± 2% capsules

Packing Details:

  1. Strip Pack the filled and polished capsules by using Strip Packing Machine as per its SOP
  2. Put 10 strips each containing 10 capsules into the carton.
  3. Seal the unit carton from both ends with cello tape.
  4. Pack the 60 unit cartons in specified corrugated box B-15 to give a pack size of 60 x 10 x 10 capsules.
  5. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

  1. Fit the mesh # 40 Stainless Steel Sieve on the Sifter as per its SOP No- SOP/NB/002/MO/II.and place Stainless Steel Container below the discharge hopper.
  2. Sift the 0.900 kgs of Aerosil through 40 mesh Stainless Steel Sieve on the sifter and let it to collect in the container kept below the discharge hopper.
  3. Sift the 1.8 kgs of Magnesium Stearate through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  4. Sift the 5.25 kgs of Pepsin through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  5. Sift the 1.8 kgs of Talcum through 40 mesh Stainless Steel Sieve on the sifter and collect in the same container.
  6. Sift the 15.750 kgs of Fungal Diastase through 40 mesh Stainless Steel Sieve on the sifter and collect in the separate container.
  7. Sift the 16.500 kgs of Di-Calcium Phosphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the separate container.
  8. Sift the 98.500 kgs of Di-Calcium Phosphate through 40 mesh Stainless Steel Sieve on the sifter and collect in the separate container and perform the following:
    • Divide it into two equal parts i.e. 2 x 49.25 kgs.
    • Take 15.75 kgs of Simethicone and divided into 2 equal parts i.e. 2 x 7.875 kgs.
    • To one part of D.C.P. at one part of Simethicone. Mix thoroughly to make dough using the Mass Mixer.
    • Similarly mix the second part of D.C.P. in another part of Simethicone individually by using Mass Mixer.
    • Now prepare the granules of the dough by passing it through the granulator
    • Dry the granules in the Tray drier at temperature not more than 70° C.
    • Sieve the dried granules through the mesh # 30 Stainless Steel Sieve on the Sifter as per its SOP and collect in the Stainless Steel Container kept below the discharge hopper.
    • Re-dry the granules in Tray drier.
    • Moisture content of these granules should not be more than 2.0%.
  • Add these granules to the sifted bulk batch.
  1. Transfer all the ingredients sifted to Roto Cube Blender. Allow blending together for 1 hour by operating Roto Cube Blender as per its SOP 
  2. Weigh the whole batch. The weight of whole batch should be in range of 154.688 kg – 156.25 kg.
  3. Send the sample to Quality Control Department for bulk testing.
  4. Start filling of Empty Hard Gelatin capsules, 521 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP 
  5. Polish the filled capsules by using Feeder, Sorter & Capsule Polishing Machine with A.D.U. as per its SOP 
  6. Strip pack the filled capsules by using Strip Packing Machine as per its SOP 

-PROCESS CONTROLS:

 

The following in-process controls should be maintained during the processing:

  1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  2. All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
  3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  4. Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.
  • Relative Humidity –   Less than 45 %
  • Temperature –   25 0C ± 2 0C
  1. The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
  2. Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.
  3. Intermittently the Assistant Manufacturing Chemist should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
  4. Detect out of limit capsules by Weight Variation Method as follows:
  5. a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:
AVERAGE WEIGHT OF CAPSULES
(in mg)		MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
Less than 300 mg10
300 mg or More7.5
  • Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.
  •  Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.
  • Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and  cross-contamination.
  • Inspection, sorting and polishing of filled capsules should be done as per SOP NO. SOP/NB/007/PG/II.
  • Disintegration of filled capsules should be done using Disintegration Testing Apparatus.
  • Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.
  •  The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.
  •  Place the capsules in each of 6 tubes along with a plastic disc over the capsules.
  • The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.
  • Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.
  • Switch on the apparatus to move the basket assembly containing the capsules up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.
  •  When the capsules have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the capsules and record the same in Batch Manufacturing Record.
  • Disintegration Time of filled capsules = Not more than 15 minutes
  • The strips and cartons should be checked thoroughly for proper batch coding.
  • Assistant Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the same as that shown in proof.
  • Intimation should be sent to Quality Control Department for finished product sampling and testing.
  • After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach the same in the Batch Manufacturing Record.
  • It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.
  • Filling or packaging of next product should not commence until the Quality Control Analyst has given the ‘Line Clearance’.

Other related post:SALBUTAMOL SULPHATE TABLET   

Capsules, MASTER FORMULAS

Omeprazole 40 mg

Posted on By ABHA
Omeprazole 40 mg

PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE:  This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

  • Master Copy : Manager Quality Assurance
  • Copy No. 1 : Production Pharmacist
  • Copy No. 2 : Manager Quality Control

Copy No. 3 : Non-β Lactam Capsule Section

PRODUCT NAME: OMIMAC – 40 CAPSULESBATCH SIZE:  1.0 LACS
PRODUCT REFERENCE CODE: UNIT SIZE:  10 ´ 10
GENERIC NAME: OMEPRAZOLE CAPSULEPACK SIZE:  24 ´ 10 ´ 10
DOSAGE FORM: CAPSULESTRENGTH: N.A.
DEPARTMENT:  NON β-LACTAM DEPARTMENTEXPIRY DATE:  AFTER 18 MONTHS   FROM THE DATE OF MANUFACTURING

 

COMPOSITION: 

  Each Capsule contains:

Omeprazole                         B.P.        40 mg

(As enteric coated pellets)

 

     EQUIPMENTS TO BE USED:

 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Sifter 
2Roto Cube Blender 
3Automatic Capsule Loading Machine 
4Semiautomatic Capsule Filling Machine 
5Feeder, Sorter & Capsule Polishing Machine With A.D.U. 
6Strip Packing Machine

RAW MATERIALS: 

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.EC PINK / PINK (SIZE: 2)–100000.000100000.00 NOS
2.OMEPRAZOLE PELLETS 14.50%B.P.29.75329.753 KGS

Packing Materials:

S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1.ADHESIVE TAPE ROLL (NEOMED)2.0002.000 NOS
2.CELLO TAPE4.0004.000 NOS
3.OMEPRAZOLE CAPS 20/40 MG INSERTS10000.00010000.000 NOS
4.UNIT CARTON (10 CAPS)10000.0002.00010002.000 nos
5.OUTER CARTON (10 X 10)            1000.0002.0001002.000 NOS
6.STRIP FOIL (FRONT)25.00025.000 KGS
7.STRIP FOIL (BACK)25.00025.000 KGS
8.CORRUAGED BOX R-4542.00042.000 NOS

 

MANUFACTURING SPECIFICATION:

  1. Use number 2 size Pink / Pink Capsules.
  2. Moisture content of granules should be less than 2.0 %.
  3. Average fill of each capsule is 298 mg.
  4. Weight Variation Limit for average weight of 20 Capsules is +5 %
  5. Disintegration time for each Capsule is not more than 15 minutes.
  6. Average weight of twenty filled capsules is 7.20 grams.
  7. Since Omeprazole is photo sensitive, all primary operations such as Batch Mixing, Filling, sorting and strip packing of Omimac capsule should be carried out in darkness and direct exposure to light should be avoided.
  8. Temperature of primary area NMT 27° C and RH not more than 45%.

      Yield:

Theoretical Yield is 1.0 Lac capsules.

Expected Practical Yield is 1.0 Lac ± 2% capsules.

Packing Details:

  1. Strip Pack the filled and polished capsules by using Strip Packing Machine as per its SOP 
  2. Put single strip each containing 10 capsules into the unit carton.
  3. Put 10 strips packed in unit carton each containing 10 capsules into the outer carton.
  4. Seal the outer carton from both ends with cello tape.
  5. Pack the 24 cartons in specified corrugated box T-16 to give a pack size of 24 x 10 x 10 capsules.
  6. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS:

 

  1. Transfer 29.753 kg of Omeprazole pellets to Roto Cube Blender.
  2. Weigh the whole batch. The weight of whole batch should be in range of 29.455 kg – 29.753 kg.
  3. Send the sample to Quality Control Department for bulk testing.
  4. Start filling of Empty Hard Gelatin capsules, 298 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP 
  5. Sort the filled capsules by using Feeder, Sorter unit of Feeder, Sorter & Capsule Polishing Machine With A.D.U. as per its SOP 
  6. Strip pack the filled capsules by using Strip Packing Machine as per its SOP

MANUFACTURING PROCESS: 

  1. Transfer 29.753 kg of Omeprazole pellets to Roto Cube Blender.
  2. Weigh the whole batch. The weight of whole batch should be in range of 29.455 kg – 29.753 kg.
  3. Send the sample to Quality Control Department for bulk testing.
  4. Start filling of Empty Hard Gelatin capsules, 298 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP
  5. Sort the filled capsules by using Feeder, Sorter unit of Feeder, Sorter & Capsule Polishing Machine With A.D.U. as per its SOP 
  6. Strip pack the filled capsules by using Strip Packing Machine as per its SOP 

MANUFACTURING PROCESS:

  1. Transfer 29.753 kg of Omeprazole pellets to Roto Cube Blender.
  2. Weigh the whole batch. The weight of whole batch should be in range of 29.455 kg – 29.753 kg.
  3. Send the sample to Quality Control Department for bulk testing.
  4. Start filling of Empty Hard Gelatin capsules, 298 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP
  5. Sort the filled capsules by using Feeder, Sorter unit of Feeder, Sorter & Capsule Polishing Machine With A.D.U. as per its SOP 
  6. Strip pack the filled capsules by using Strip Packing Machine as per its SOP

MANUFACTURING PROCESS:

  1. Transfer 29.753 kg of Omeprazole pellets to Roto Cube Blender.
  2. Weigh the whole batch. The weight of whole batch should be in range of 29.455 kg – 29.753 kg.
  3. Send the sample to Quality Control Department for bulk testing.
  4. Start filling of Empty Hard Gelatin capsules, 298 milligrams of blended powder in each capsule shell by using Automatic Capsule Loading Machine and Semiautomatic Capsule Filling Machine as per their SOP
  5. Sort the filled capsules by using Feeder, Sorter unit of Feeder, Sorter & Capsule Polishing Machine With A.D.U. as per its SOP
  6. Strip pack the filled capsules by using Strip Packing Machine as per its SOP 

IN-PROCESS CONTROLS:

The following in-process controls should be maintained during the processing:

  1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  2. All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
  3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  4. Humidity and temperature should be maintained during the manufacturing, filling, polishing and packaging of the capsules.
  • Relative Humidity –   Less than 45 %
  • Temperature –   25 0C ± 2 0C
  1. The total weight of blended powder should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
  2. Bulk sample should be sent for analysis to Quality Control Department before starting the filling of hard gelatin capsules.
  3. Intermittently the Assistant Manufacturing Chemist should check weight variation of filled capsules at interval of 30 minutes and record for the same should be kept in Batch Manufacturing Record.
  4. Detect out of limit capsules by Weight Variation Method as follows:
  5. a) Take the average weight of 20 Capsules on the calibrated balance and calculate the upper and lower limit as per the table given below in accordance with IP/BP:

 

AVERAGE WEIGHT OF CAPSULES
(in mg)		MAXIMUM PERCENTAGE DIFFERENCE                                                                      ALLOWED
Less than 300 mg10
300 mg or More7.5

 

  • b) Take the weight of individual Capsules and check if all the Capsules are lying with in the limits.
  • c) Select the Capsules only if no more than two Capsules are out of percentage limit and if none Capsule differs by more than 2.5 times the percentage limit, otherwise reject the Capsules.
  • Capsules taken for testing and In-process control should not be added to the bulk batch to avoid mix-ups and cross-contamination.
  • Inspection, sorting and polishing of filled capsules should be done as per SOP NO. SOP/NB/007/PG/II.
  • Disintegration of filled capsules should be done using Disintegration Testing Apparatus.
  • i) Disintegration is the time required for the group of capsules to disintegrate. Disintegration Test should be carried out at regular interval of 1 hour by using Disintegration Test Apparatus.
  • ii) The tube assembly unit is removed from the glass beaker and from each tube the plastic discs are removed.
  • iii) Place the capsules in each of 6 tubes along with a plastic disc over the capsules.
  • iv) The glass beaker is filled with water. The water in the beaker is retained at the temperature of 37+1˚C through out the test by suitably setting the thermostat.
  • v) Introduce a tube assembly unit into glass beaker in such a way that wire mesh at the base of each tube is atleast 2.5cm below the surface of liquid when the basket is at highest position.
  • vi) Switch on the apparatus to move the basket assembly containing the capsules up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute. Start the stopwatch.
  • vii) When the capsules have disintegrated i.e. when no particles remain on the wire mesh at the bottom of tube, stop the stopwatch. Note the time taken for disintegration of the capsules and record the same in Batch Manufacturing Record.
        Disintegration Time of filled capsules = Not more than 15                 minutes
  • The strips and cartons should be checked thoroughly for proper batch coding.
  • Assistant Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of strips are being packed in each cartons and also the number of cartons in each shipper is exactly the samthat shown in proof.
  • Intimation should be sent to Quality Control Department for finished product sampling and testing.
  • After the completion of labelling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Fill the destruction sheet and attach
  • the same in the Batch Manufacturing Record.
  • It will be ensure that filling or packaging equipment has been properly cleaned after the completion of batch.
  • Filling or packaging of next product should not commence until the Quality Control Analyst has given the ‘Line Clearance’.

Other related Post:Omeprazole 20 mg

Capsules, MASTER FORMULAS