Month: October 2020

MFR of Amikacin Sulphate Injection

Posted on By ABHA

MFR of Amikacin Sulphate Injection

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.

Also Read:- MFR of Chloramphenicol EYE/EAR Drops

RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of  Manufacturing Chemist to follow and adhere to this MFR. The Production Manager, 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 Manager
  3. Copy No. 2 : Manager Quality Control
  4. Copy No.   3 :   Small Volume Parenteral Section

PRODUCT NAME: MFR of Amikacin Sulphate InjectionBATCH SIZE: 100 LTRS.
PRODUCT REFERENCE CODE: UNIT SIZE:  2 ml/white/Vial
GENERIC NAME: Amikacin Sulphate Inj.                       PACK SIZE:  30 x 50 x 2ML
DOSAGE FORM: Parenteral dosage form STRENGTH: 250 mg/ml
DEPARTMENT:  STERILE PREPRATIONEXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

Each 2ml contains: –

Amikacin SulphateI.P
Equivalent to Amikacin500 mg
Water for injectionI.Pqs

EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1Auto Rotary Vial Washing Machine
2Butyl Bung Washing Machine
3Dry Heat Sterilizer
4Auto Clave with SS Transfer trolley
5Multi Column Distillation Still
6Distill Water Storage Tank
7SS Batch Mixing Tank
8SS Pressure Vessel – 100 Ltr.
9SS Membrane Filtration Assembly (293 mm)
10SS Filling Vessel  – 100 Ltr
11Auto Liquid Vial Filling, Stoppering & Sealing Machine
12Vial Visual Inspection Table
13Auto Vial Labelling Machine

Equipments to  be sterilized :- 

SR NONAME OF EQUIPMENTS STERLIZATION AS PER SOP NO.
1S.S Membrane vessel- 293 MM
2S.S Filling vessel
3S.S Filling syringes
4Sterile dress of operator
5Pre Nitrogen Filling needles& POST- nitrogen filling needles
6Silicon tubes

RAW MATERIALS: 

S.N.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.AMIKACIN SULPHATEI.P.37.8005.0039.690 KGS
2.EDTAI.P.0.040–0.040 KGS
3.METHYL PARABEN SODIUMI.P.0.080–0.080 KGS
4.PROPYL PARABEN SODIUMI.P.0.020–0.020 KGS
5.S.M.B.SI.P.0.500–0.500 KGS
6.TRI – SODIUM CITRATE (SD)I.P.2.500–2.500 KGS

MANUFACTURING PROCESS:

Preparation of Solution:

Take in SS Batch Mixing Tank 60 Lt. of freshly prepared hot distilled water.

Dissolve Methyl Paraben & Propyl Paraben to Batch Mixing Tank Stir it properly till mix.

Dissolve EDTA SMBS and stir properly.

Add Tri sodium citrate and stir it properly.

Dissolve Amikacin Sulphate.

Adjust the pH to 4.5  (pH range: 3.5 to 5.5)

Make up the volume to 100.00 liter

Final pH = 4.5

Shift the solution from batch mixing tank to pressure vessel and do membrane

Filtration by using the appropriate membrane.

Washing

Washing of vials

Vial washing is done with auto rotary vial washing M/c as per sop.

Washing of Butyl Bungs

Butyl Bungs washing is done with Butyl Bungs Washing as per sop.

Sterilization

Dry Heat Sterilization (Vials)

Dry Heat Sterilization is done with the help of Dry heat Sterilizer at the following conditions as per sop.

1Temperature250°C
2Holding Time1 hour

Moist Heat Sterilization (Butyl Bungs)

Moist heat sterilization for butyl bungs is done with the help of Autoclave with SS Transfer Trolley at following conditions as per sop

APressure15 lbs
BTemperature121° C
CHolding Time30 Minutes

Filtration

Filtration is done with the membrane assembly by using the appropriate membrane & pre filter and post filter

APre Filter1.5  µ
BMembrane Filter0.2  µ

Aseptic Filing

After the process of washing, sterilization filtration filing of Aseptic filing is carried out in class 100 area under the laminar flow. The machine adjustment is carried out for the appropriate vials as per SOP.

AFilling M/C Adjustment
BButyl Bung Station Adjustment
CSealing Station Adjustment

Volume variation is checked intermittently, volume prescribed 2.ml and volume filled 2.0 ml, percentage variation 2%.

Visual Inspection

Visual inspection is carried out for filled vials by using vial visual inspection table M/c as per SOP.

Labeling

Labeling of vials is done with the help of auto vials labeling machine as per sop

Packing

1Open PackingYes/noYesPack SizeNA
2Blister PackingYes/noNoPack Size30 x 50 x 2ml

Yield

1Percentage Yield–100 ± 2%
2Theoretical Yield–50000 x 2ml
3Expected Practical Yield–50000 x 2ml ± 2%

Packing Details:

Label the filled vials &Blister the labeled vials

Pack such 10 labeled blister pack each of 5vial in each outer carton

Seal outer carton with cello tape

Pack the 30 outer cartons in specified corrugated box to give pack size of 30 x 10 x 5 x 2ml.

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

IN-PROCESS CONTROLS:-

THE following in process controls should be maintained during  the processing

Check raw  material 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 Manager and QC/QA Manager.

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

Final volume should be made as per Standard Operating Procedure.

pH of the bulk should be checked and it should be with in specified limits.

Bulk sample should be sent for analysis to Q.C. Department before starting the filling and sealing stage.

Intermittently filled volume should be checked at 30 minutes interval by the  Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.

The net volume should be checked for all the filling nozzles and in no case net volume should be less than the volume claimed on the label. (Limit for volume variation: volume claimed + 2%.

Visual inspection of filled and sealed vials should be done as per SOP  and the record of the same should be kept in B.M.R.

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

Intimation should be sent to Q.C. Department for finished product sampling and testing.

After the completion of labeling and packaging the coded labels and cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA  Manager. Maintain the destruction of the same in the B.M.R.

It will be ensure that filling or packing equipment has been properly cleaned.

Filling or packaging of next product should not commence until the the ‘Line Clearance’ has been given by the Q.A. Analyst.

Injections, MASTER FORMULAS

MFR of Chloramphenicol EYE/EAR Drops

Posted on By ABHA

MFR of Chloramphenicol EYE/EAR Drops

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 MFR. The Production Manager, 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 Manager
  3. Copy No. 2 : Manager Quality Control
  4. Copy No.  3 :    Small Volume Parenteral Section

 

PRODUCT NAME: Chloramphenicol EYE/EAR DropsBATCH SIZE:  100 LTRS.
PRODUCT REFERENCE CODE: UNIT SIZE:  10 ml
GENERIC NAME: N.A.PACK SIZE:  576 X 10 ml.
DOSAGE FORM: OPTHALAMICSTRENGTH: 0.5 %  w/v
DEPARTMENT:  STERILE PREPRATIONEXPIRY DATE: AFTER 30 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:
Chloramphenicol I.P.0.5 % w/v
Phenyl Mercuric Nitrate (as preservative)   I.P0.001 % w/v
Sterile aqueous baseq.s.

 

EQUIPMENTS TO BE USED:

 

SR. NO.

 

NAME OF EQUIPMENT

 

ASSEMBLING

AS PER SOP NO.

 

CLEANING

AS PER SOP NO.

1Auto Clave with SS Transfer trolley
2Multi Column Distillation Still
3Distill Water Storage Tank
4SS Batch Mixing Tank
5SS Pressure Vessel – 100 Ltr.
6SS Membrane Filteration Assembly (293 mm)
7SS Filling Vessel  – 100 Ltr.
8Auto Liquid Vial Filling, Stoppering & Sealing Machine
9Auto Vial Labelling Machine

Equipments to  be sterilized :

SR.NO.NAME OF EQUIPMENTSSTERLIZATION AS PER SOP NO.
1S.S Membrane Filter Assembly- 293 MM
2S.S Filling vessel
3S.S Filling syringes
4Sterile dress of operator
5Pre Nitrogen Filling needles& POST- nitrogen filling needles
6Silicon tubes

RAW MATERIALS:

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1CHLORAMPHENICOLI.P0.5005.00.525 KGS
2.BORIC ACIDI.P1.500–1.500 KGS
3.BORAXI.P0.600–0.600 KGS
4.H.P.M.CI.P0.075–0.075 KGS
5.PEG – 400I.P.5.000–5.000 KGS
6.PHENYL MERCURIC NITRATEI.P.0.001–0.001 KGS
7.UREAI.P.0.600–0.600 KGS

 

PACKING MATERIALS:

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

RECORD

TOTAL QUANTITY USED
110 ml PLASTIC  VIALS WITH CAP & NOZZLE (PRE STERILIZED)10000.000–10000.000 NOS
2ADHESIVE TAPE ROLL BROWN1.000–1.000 NOS
3CELLO TAPE1.000–1.000 NOS
4CORRUGATED BOX  C-01A17.361–17.361 NOS
5CHLORAMPHENICOL – 10 ml  EYE DROPS STICKER LABEL100183.00010021 NOS
6CHLORAMPHENICOL – 10 ml  EYE DROPS UNIT CARTONS10000.0002.0010002.000 NOS
7CHLORAMPHENICOL – 10 ml  EYE DROPS OUTER CARTONS416.6672.000418.667 NOS

MANUFACTURING PROCESS:

 Preparation of Solution:

Take in SS Batch Mixing Tank 300 Lt. of freshly prepared water for injection.

Add Boric Acid & Borax in distilled water and stir it properly.

Take Phenyl Mercuric Nitrate and dissolve it separately in hot distilled water and add to Batch Mixing Tank Stir it properly.

Dissolve Urea and stir properly.

Dissolve Chloramphenicol in water and add to it PEG-400 and put in BMT.

Dissolve Hydroxy Propyl Methyl Cellulose Solution and stir vigorously.

Adjust the pH to 7.2 (pH RANGE: 7.0 TO 7.5)

Make up the volume to 100.00 liter

Final pH = 7.2

Shift the solution from batch mixing tank to pressure vessel and do membrane filtration by using the appropriate

II) Filtration

Filtration is done with the membrane assembly by using the appropriate membrane & pre filter and post filter.

Pre Filter1.5 µ
BMembrane Filter0.2 µ

Aseptic Filing

After the process of washing, sterilization filtration filing of Aseptic filing is carried out in class 100 area under the

laminar flow. The machine adjustment is carried out for the appropriate vials as per SOP .

Filling Station AdjustmentYes/noYes
BButyl Bung Station AdjustmentYes/noNo
CSealing Station AdjustmentYes/noYes

IV)  Volume variation is checked intermittently, volume prescribed 10.0 ml, and volume filled 10.1 ml, percentage variation 2%.

V) Labeling

Labeling of vials is done with the help of auto vials labeling machine as per sop.

 VI) Packing 

Open PackingYes/noYesPack Size24 x 24 x 10 ml
2Blister PackingYes/noNoPack SizeNA

VII)  Yield

Percentage Yield–100 ± 2%
2Theoretical Yield–10000 x 10 ml
3Expected Practical Yield–10000  x 10 ml ± 2%

MANUFACTURING SPECIFICATION:

Average fill of each vial is 10 ml.

Weight variation limit allowed in each filled vial is 10.0 ml to 10.1 ml.

Use accurate quantity of water to make up the final volume of the solution.

Filter the completely charged batch solution using membrane Filtration apparatus using appropriate Membrane filter, pre membrane filter.

Transfer the solution from mixing tank to pressure tank after complete charging of batch.

Temperature should be kept at 25°c for entire operation, relative humidity should be kept at 40% for Entire operation.

Packing Details :

Pack the filled vials in unit carton

Pack such 24 unit cartoons in each outer carton.

Pack the 24 outer cartons in specified corrugated box to give pack size of 24 x 24 x 10 ml.

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

Also Read :– MFR of Pantoprazole Sodium Sesquihydrate Injection

IN-PROCESS CONTROL:-

The following in process controls should be moistened during  the processing

Check raw  material used for manufacturing purpose are all approved 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 Manager and QC/QA Manager.

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

Final volume should be made as per Standard Operating Procedure.

pH of the bulk should be checked and it should be with in specified limits.

Bulk sample should be sent for analysis to Q.C. Department before starting the filling and sealing stage.

Intermittently filled volume should be checked at 30 minutes interval by the  Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.

The net volume should be checked for all the filling nozzles and in no case net volume should be less than volume claimed on the label. (Limit for volume variation: volume claimed + 2%

Visual inspection of filled and sealed vials should be done as per SOP NO. SOP/SV/016/GN/II and the record of the same should be kept in B.M.R.

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

Intimation should be sent to Q.C. Department for finished product sampling and testing.

After the completion of labeling and packaging the coded labels and cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the B.M.R.

It will be ensure that filling or packing equipment has been properly cleaned.

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

Carry out bubble test for checking the integrity of membrane filter as per SOP.

EYE /EAR DROPS, MASTER FORMULAS

BETAMETHASONE AND NEOMYCIN EYE/EAR DROPS

Posted on By ABHA

BETAMETHASONE AND NEOMYCIN EYE/EAR DROPS

Betamethasone & Neomycin Sulphate Eye/Ear Drops are a combination drug of antibiotic and steroid medicine that is used when there is a risk of bacterial infection in or around the eye.

USES OF BETAMETHASONE & NEOMYCIN EYE / EAR DROPS

Betamethasone & Neomycin Sulphate Eye / Ear Drops are used to treat eye inflammation caused by bacterial infections.

DOSAGE FORM: OPHTHALMIC DOSAGE FORM

Label claim:
Neomycin Sulphate IP                                       0.5% w/v
Betamethasone Sodium Phosphate IP              0.1%  w/v
Benzalkonium Chloride (as preservative) IP      0.02%  v/v
Aqueous buffered vehicle                                  q.s

SIDE EFFECTS

  • Eye irritation
  • Swelling
  • Eye pain
  • Blurred vision

HOW TO USE

This medication is for external use only. It is advisable to take this medicine as per prescribed by your doctor. Follow the directions as given on the prescription label. For ear application- Hold the dropper close to the ear without touching it. Gently squeeze the dropper and place the medicine inside the ear. For eye application- Gently squeeze the dropper and place the medicine inside the lower eyelid. Wipe off the extra liquid.

HOW TO DO BETAMETHASONE & NEOMYCIN SULPHATE EYE / EAR DROPS WORK

Betamethasone & Neomycin Sulphate Eye / Ear Drops are combination drugs containing Betamethasone and Neomycin Sulphate. Betamethasone is a corticosteroid that helps in reducing swelling, itching, and redness of the skin. Neomycin Sulphate stops bacterial growth by preventing the synthesis of essential proteins.

Also Read:– MFR of Pantoprazole Sodium Sesquihydrate Injection

EQUIPMENT TO BE USED FOR MANUFACTURING: 

  • Auto Clave with SS Transfer trolley
  • Multi-Column Distillation Still
  • Distill Water Storage Tank
  • SS Batch Mixing Tank
  • SS Pressure Vessel – 100 Ltr.
  • SS Membrane Filtration Assembly (293 mm)
  • SS Filling Vessel  – 100 Ltr
  • Auto Liquid Vial Filling, Stoppering & Sealing Machine
  • Auto Vial Labelling Machine

 Equipment to  be sterilized :

  • S.S Membrane Filter Assembly
  • S.S Filling vessel
  • S.S Filling syringes
  • Sterile dress of the operator
  • Pre Nitrogen Filling needles& POST- nitrogen-filling needles
  • Silicon tubes

RAW MATERIALS USED IN MANUFACTURING                                                                                                  

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.BORIC ACID I.P.0.200–0.200 KGS
2.BORAXI.P.0.320–0.320 KGS
3.BETAMETHASONE SODIUM PHOSPHATEI.P.100.00015.000115.000 GMS
4.BENZYLKONIUM CHLORIDEI.P.0.02–0.02 KGS
5.EDTAI.P.0.040–0.040 KGS
6.DI SODIUM HYDROGEN ORTHOPHOSPHATEI.P.0.280–0.280 KGS
7.NEOMYCIN SULPHATEI.P.0.50020.0000.600 KGS
8.S.M.B.SI.P.0.300–0.300 KGS
9.SODIUM DI HYD. ORTHOPHOSPHATEI.P.0.066–0.066 KGS
10.TRI SODIUM ORTHOPHOSPHATEI.P.0.040–0.040 KGS
11.TWEEN – 80 (SD)I.P.0.010–0.010 LTRS

 

PACKING MATERIALS:

  • 10 ML PLASTIC  VIALS WITH CAP & NOZZLE (PRE-STERILIZED)
  • STICKER LABEL
  • UNIT CARTONS
  • OUTER CARTONS
  • INSERTS
  • CORRUGATED BOX

MANUFACTURING PROCESS OF BETAMETHASONE & NEOMYCIN EYE / EAR DROPS:

I) Preparation of Solution:

  1. Take in Mixing Tank and take 70 Lt. of freshly prepared distilled water.
  2. Dissolve Boric Acid and Borax in 10 Ltr. of water and add to Batch Mixing Tank Stir it properly.
  3. Dissolve Betamethasone sodium phosphate and stir properly.
  4. Dissolve Di-Sodium Orthophosphate and monosodium orthophosphate & Tri-Sodium phosphate and add to the mixing tank stir it properly.
  5. Dissolve SMBS & EDTA in water and pour in BMT.
  6. Dissolve Benzylkonium Chloride in the mixing tank.
  7. Dissolve Neomycin Sulphate and add it to the mixing tank.
  8. Dissolve Tween – 80
  9. Adjust the pH to 7.1 (pH RANGE: 6.8 TO 7.2)
  10. Make up the volume to 100.00 Ltr.
  11. Shift the solution from the mixing tank to the pressure vessel and do membrane filtration.

II) Filtration

Filtration is done with the membrane assembly by using the appropriate pre-filter and post-filter i.e. membrane – Pre Filter 1.5 µ & Membrane Filter 0.2 µ.

III)     Aseptic Filing

After the process of washing, sterilization Filteration filing of Aseptic filing is carried out in the class 100 area under the laminar flow. The machine adjustment is carried out for the appropriate vials.

Butyl Bung Station Adjustment

Sealing Station Adjustment

VI)   Volume variation is checked intermittently, volume prescribed 5ml, and volume filled 5.05 ml, percentage variation 10%.

Packing Details:

  1. Pack the filled vials in a unit carton
  2. Pack such 24 cartoons in each outer carton
  3. Seal the outer carton with cello tape
  4. Pack the 24 outer cartons in the specified corrugated box to give a pack size of 24 x 24 x 10 ml.
  5. Seal the corrugated box with adhesive tape and label it properly by affixing the specified label

IN-PROCESS CONTROLS DURING THE MANUFACTURING OF EYE / EAR DROPS:-

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

  1. Check raw materials used for manufacturing purposes are all approved materials and have ‘released’ labels fixed on them.
  2. 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 the Production Manager and QC/QA Manager.
  3. Physical characteristics of Raw materials like colour, odour, and consistency are checked before compounding.
  4. The final volume should be made as per Standard Operating Procedure.
  5. pH of the bulk should be checked and it should be within specified limits.
  6. Bulk samples should be sent for analysis to QC Department before starting the filling and sealing stage.
  7. Intermittently filled volume should be checked at 30-minute intervals by the  Manufacturing Chemist and a record for the same should be kept in Batch Manufacturing Record.
  8. The net volume should be checked for all the filling nozzles and in no case, the net volume should be less than the volume claimed on the label. (Limit for volume variation: volume claimed + 5%.
  9. The labels and cartons should be checked thoroughly for proper batch coding.
  10. Intimation should be sent to QC Department for finished product sampling and testing.
  11. After the completion of labeling and packaging, the coded labels and cartons should be accounted for rejected printed material should be destroyed in the presence of the QC/QA  Manager. Maintain the destruction of the same in the BMR.
  12. It will ensure that the filling or packing equipment has been properly cleaned.
  13. Filling or packaging of the next product should not commence until the ‘Line Clearance’ has been given by the IPQA.
  14. Carry out bubble test for checking the integrity of membrane filter as per SOP.
EYE /EAR DROPS, MASTER FORMULAS

MFR of Pantoprazole Sodium Sesquihydrate Injection

Posted on By ABHA
MFR of Pantoprazole Sodium Sesquihydrate Injection

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.

Also Read:- MFR of Hungry Syrup

RESPONSIBILITY / ACCOUNTABILITY:

 It is the responsibility of  Manufacturing Chemist to follow and adhere to this MFR. The Production Manager, 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 Manager
  3. Copy No. 2 : Manager Quality Control
  4. Copy No. 3 :   Small Volume Parenteral Section

PRODUCT NAME :

Pantoprazole Sodium Sesquihydrate Dry Injection

BATCH SIZE:  1.250KG.
PRODUCT REFERENCE CODE:  UNIT SIZE:  40.0mg
GENERIC NAME: PANTOPRAZOLE SODIUM  INJECTIONPACK SIZE: 6X40 mg
DOSAGE FORM: PARENTERAL DOSAGE FORMSTRENGTH: 40.0mg
DEPARTMENT:  STERILE PREPARATIONEXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

 COMPOSITION:

Each Vial Contains

Pantoprazole Sodium Sesquihydrate

Equivalent to Pantoprazole Sodium                    40.0mg

 

EQUIPMENTS TO BE USED:

 

SR. NO.

 

NAME OF EQUIPMENT

 

ASSEMBLING

AS PER SOP NO.

 

CLEANING

AS PER SOP NO.

1.Butyl Bung Washing Machine
2Semi Auto Vial  Washing Machine
3Auto Clave with SS Transfer trolley
4Dry Heat Sterilizer
5Double Cone Blender Machine
6Auto Dry Powder Vial Filling, Stoppering & Sealing Machine
7Semi Auto Vial Visual Inspection Machine
8Auto Vial Labelling Machine

RAW MATERIALS:

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.PANTOPRAZOLE  SODIUM–1.250–1.250 KGS
2.ISO PROPYL ALCOHOLI.P.0.666–0.666KGS
S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR

RECORD

TOTAL QUANTITY USED
1.10ML CLEAR VIALS10000.00010000.000
2.FLIP OFF SEALS RED –13MM10000.00010000.000NOS
3.RUBBER STROPPER-20MM10000.00010000.000 NOS
4.ADHESIVE TAPE ROLL BROWN2.0002.000 NOS
5.CELLO TAPE2.0002.000 NOS
6.GUM ACCACIA0.5000.500KG
7.CORRUGATED BOXES C-3775.75075.750 NOS
8.PANTOMAC-40MG INJ INSERT10000.0002.00010002.000 NOS
9.PANTOMAC-40MG UNIT CARTON10000.0002.00010002.000NOS
10.PANTOMAC-40MG LABEL10100.0003.00010103..000NOS
11.PANTOMAC-40MG 6X40 mg OUTER CARTON1667.8501667.850NOS
12.PL TRAY(10ML VIAL + 10ML AMPS)10000.00010000.000NOS

PACKING MATERIALS:

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

RECORD

TOTAL QUANTITY USED
1.10ML CLEAR VIALS10000.00010000.000
2.FLIP OFF SEALS RED –13MM10000.00010000.000NOS
3.RUBBER STROPPER-20MM10000.00010000.000 NOS
4.ADHESIVE TAPE ROLL BROWN2.0002.000 NOS
5.CELLO TAPE2.0002.000 NOS
6.GUM ACCACIA0.5000.500KG
7.CORRUGATED BOXES C-3775.75075.750 NOS
8.PANTOMAC-40MG INJ INSERT10000.0002.00010002.000 NOS
9.PANTOMAC-40MG UNIT CARTON10000.0002.00010002.000NOS
10.PANTOMAC-40MG LABEL10100.0003.00010103..000NOS
11.PANTOMAC-40MG 6X40 mg OUTER CARTON1667.8501667.850NOS
12.PL TRAY(10ML VIAL + 10ML AMPS)10000.00010000.000NOS

MANUFACTURING PROCESS:

  1. Make sure that the relative humidity of filling room is under the controlled limits of 25% + 5%.
  2. Make sure that the filling room temperature is under the controlled limits of 20˚C + 5˚C
  3. Make sure that the sealed container of sterile Pantoprazole Sodium powder is pasted with QC approval.
  4. Make sure that all the adjustments for 10ml vial size have been made, place Pantoprazole Sodium powder in hopper
  5. Place empty 10ml vials upright on the in feed portion of conveyor.
  6. Make sure that sufficient amount of 10ml vials are to be filled
  7. Make sure that air pressure should be adjusted to 15psi.
  8. Turn dose switch to ‘ON’ position.
  9. Allow the vial to pass through conveyor guide channel & ensure the powder filling.
  10. Turn ‘ON’ the stopper hopper switch & make sure that stopper is feeding properly.
  11. Check the weight variation of Pantoprazole powder filling; it should be within prescribed limits of 1.08gm.
  12. Turn on sealing station switch & make sure sealing of vial is done properly.

Yield

1Percentage Yield–100± 2%
2Theoretical Yield–4629 x 40.0 mg
3Expected Practical Yield–4629 x 40.0 mg ± 2%

Packing Details:

1.Pack each filled vials in unit carton followed by 10ml ampoule of sterile water.

2.Pack unit cartons in outer carton.

3.Seal outer carton with cello tape.

4.Pack the outer cartons in specified corrugated box to give pack size of 500 x 40.0 mg.

5.Seal the corrugated box with adhesive tape & label it properly by affixing the specified label

MANUFACTURING PROCESS:

  1. Make sure that the relative humidity of filling room is under the controlled limits of 25% + 5%.
  2. Make sure that the filling room temperature is under the controlled limits of 20˚C + 5˚C
  3. Make sure that the sealed container of sterile Pantoprazole Sodium powder is pasted with QC approval.
  4. Make sure that all the adjustments for 10ml vial size have been made, place Pantoprazole Sodium powder in hopper
  5. Place empty 10ml vials upright on the in feed portion of conveyor.
  6. Make sure that sufficient amount of 10ml vials are to be filled
  7. Make sure that air pressure should be adjusted to 15psi.
  8. Turn dose switch to ‘ON’ position.
  9. Allow the vial to pass through conveyor guide channel & ensure the powder filling.
  10. Turn ‘ON’ the stopper hopper switch & make sure that stopper is feeding properly.
  11. Check the weight variation of Pantoprazole powder filling; it should be within prescribed limits of 1.08gm.

12.Turn on sealing station switch & make sure sealing of vial is done properly.

IN-PROCESS CONTROLS :

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

  1. Check raw  material 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  Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Manager and QC/QA Manager.
  3. Physical characteristics of Raw material like colour, odour and consistency are checked before compounding.
  4. Final volume should be made as per Standard Operating Procedure.
  5. Bulk sample should be sent for analysis to Q.C. Department before starting the filling and sealing stage.
  6. Intermittently filled weight should be checked at 30 minutes interval by the Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.
  7. The net weight should be checked for all the filling nozzles and in no case,net volume should be less than weight claimed on the label. (Limit for weight variation: weight claimed + 2%)
  8. Visual inspection of filled and sealed vials should be done as per SOP  and the record of the same should be kept in B.M.R.
  9. The labels and cartons should be checked thoroughly for proper batch coding.
  10. Intimation should be sent to Q.C. Department for finished product sampling and testing.
  11. After the completion of labeling and packaging, the coded labels and cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA  Manager. Maintain the destruction of the same in the B.M.R.
  12. It will be ensure that filling or packing equipment has been properly cleaned.
  13. Filling or packaging of next product should not commence until the  ‘Line Clearance’ has been given by the IPQA
Injections, MASTER FORMULAS

MFR of Cyproheptadine HCl Syrup

Posted on By ABHA

MFR of Cyproheptadine HCl Syrup

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

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: Liquid Section

PRODUCT NAME: Cyproheptadine HCl SyrupBATCH SIZE:  1000 LTRS.
PRODUCT REFERENCE CODE: UNIT SIZE:  100 ml
GENERIC NAME: N.A.PACK SIZE:  42 x 100 ml
DOSAGE FORM: SYRUPSTRENGTH: N.A.
DEPARTMENT:  LIQUID DEPARTMENTEXPIRY DATE: AFTER 36 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION:

Each 5 ml contains:

Cyproheptadine HCl               B.P.       2 mg

EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1Sugar Syrup Manufacturing Tank
2Sugar Storage Tank
3Charging Tank – 1000 Ltrs.
4Filter Press
5Storage Tank –  1000 Ltrs
6Linear Bottle Washing Machine
7  Digipack  Bottle Filling And Sealing Machine
8Automatic Bottle Labelling Machine

RAW MATERIAL:-

S.NOINGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1ASPARTUMB.P0.1000.100 KGS.
2CITRIC ACIDB.P0.9000.900 KGS.
3CYPROHEPTADINE HCLB.P0.40010.000.440 KGS.
4LIQUID GLUCOSEB.P150.000150.000 KGS.
5METHYL PARABEN SODUIMB.P1.0001.000 KGS.
6ORANGE FLAVOURF.G2.5002.500 LTRS.
7PROPYL PARABEN SODIUMB.P0.2500.250 KGS.
8SPIRIT CLOROFORMB.P18.00018.000 LTRS
9SUNSET YELLOW SUPRA      FCF             30.00030.000 GMS.
10SUGARF.G500.000500.000 KGS.

PACKING MATERIAL:

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

RECORD

TOTAL QUANTITY USED
1.100 ML AMBER BRUTE  BTL10000.00010000.000 NOS.
2.ADHESIVE TAPE ROLL BROWN3.0003.000 NOS.
3.GUM ACCACIA1.001.00 KGS.
4.CORRUGATED BOX238.00238.00 NOS.
5.PILFER PROOFS CAPS 25 MM10000.00010000.000 NOS.
6.UNIT CARTON10000.0002.00010002.000 NOS.
7.LABEL10238.003.00010241.00 NOS.

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 100 ml.

Volume variation limit allowed in each filled Bottle is 100 ml to 102 ml.

Make up the final volume of the syrup accurately.

Filter the completely charged batch using Filter Press L-21 by operating it as per its SOP.

Transfer the syrup from charging tank L-07 to storage tank L-12 after complete charging of batch.

Mix the batch, Fill the bottles and also perform the primary packing of bottles at temperature not more than 250 C and Relative Humidity not more than 40.

Yield:

Theoretical Yield is 10000 Bottles.

Expected Practical Yield is 10000 + 2% Bottles.

Packing Details:

Wash the bottles on Linear Bottle Washing Machine L-24 and operate it as per its SOP.

Transfer the Syrup from storage tank to Digipack Bottle Filling and Sealing Machine for filling and then sealing of the bottles as per its SOP.

Fill 100 ml syrup in amber glass brute bottle and use 25 mm PP Cap to seal the bottle mouth.

Inspect the each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.

Label every inspected bottle by using the Automatic Bottle Labelling Machine

Pack each filled and sealed bottle in unit carton individually.

Pack 42 unit cartons in specified corrugated box to give a pack size of 42 x 100 ml.

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

MANUFACTURING PROCESS:

Preparation of Sugar Syrup:

Take Purified water 160 Ltrs into Stainless Steel Steam Jacketed Sugar Syrup Preparation Tank.

Run the steam into the jacket so as to heat the water.

Add 5000 kgs of sugar into the tank and start stirring by operating the tank .

Heat continuously till the sugar dissolves completely to give uniform Sugar Syrup.

Transfer the prepared Sugar Syrup to Sugar Syrup Storage Tank  through transfer pump.

Transfer the 150 kgs Liquid Glucose to the Sugar Syrup Storage Tank and stir it vigoursly for half an hour to dissolve it in the Sugar Syrup completely.

Transfer the prepared Syrup from Sugar Syrup Storage Tank to Charging Tank  through transfer pump.

II) Addition of Ingredients into the Charging Tank L-07 while stirring continuously:

Dissolve 1.00 kgs of Methyl Paraben Sodium, 0.250 kgs of Propyl Paraben Sodium in 5.0  Ltrs of  Purified water and add to the bulk batch.

Dissolve 0.900 kgs of Citric Acid in 4 Ltrs of Purified water and add to the bulk batch.

Dissolve 0.050 kgs of Aspartum in 2 Ltr of Purified water and add to the bulk batch.

Dissolve 0.440 kgs of Cyproheptadine HCl in 18 LTRS of Spirit Chloroform and add to the bulk batch.

Dissolve 30.0 gms of Sunset Yellow Supra in 2 Ltr of Purified water and add to the bulk batch.

Add 2.500 Ltrs of Orange Flavour to the bulk batch.

Make up the volume with Purified water and mix until homogeneous.

Check the pH of Solution to be in between 4.0 – 4.5.

Filter the batch through Filter Press  by operating it as per its SOP and transfer it to the Storage Tank.

Send the sample to Quality Control Department for bulk testing.

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.

Final volume should be made as per Standard Operating Procedure using correct dipstick in the Assistant Manufacturing Chemist.

pH of the bulk should be checked and it should be with in specified limits.

Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.

The Manufacturing Chemist should check intermittently filled volume at 30 minutes interval and record for the same should be kept in Batch Manufacturing Record.

The net volume should be checked for all the filling nozzles and in no case, net volume should be less than volume claimed on the label.

Limit for Volume Variation:  Volume claimed on the label + 2ml

Visual inspection of filled and sealed bottles should be done as per SOP and the record of the same should be kept in the Batch Manufacturing Record.

Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.

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

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

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

It will be ensure that filling or packaging equipment has been properly cleaned.

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

 

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Oral Liquid, MASTER FORMULAS

MFR of Alfacalcidol & Calcium Carbonate Tablets

Posted on By ABHA

MFR of Alfacalcidol & Calcium Carbonate

PURPOSE: This Master Formula Record 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:

  1. Master Copy: Manager Quality Assurance
  2. Copy No. 1: Production Pharmacist
  3. Copy No. 2: Manager Quality Control
  4. Copy No. 3:  Tablet Section
PRODUCT NAME: Alfacalcidol & Calcium CarbonateBATCH SIZE:  50,000
PRODUCT REFERENCE CODE: UNIT SIZE:  5 x 10
GENERIC NAME: N.A.PACK SIZE:  100 x 5 x 10
DOSAGE FORM: TABLETSTRENGTH: N.A.
DEPARTMENT:  TABLET DEPARTMENTEXPIRY DATE: AFTER 24 MONTHS   FROM THE DATE OF MANUFACTURING

COMPOSITION: 

Each film coated Tablet contains:

Alfacalcidol                                                                                  0.25 mcg

Calcium Carbonate                                   I.P.                                500 mg

(Oyster Shell equ. to elemental Calcium 200 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 – I
3Roto Cube Blender –I
4Rapid Mixer Granulator
5Multi Mill
6Fluidized Bed Drier
7Oscillating Granulator
8Sifter Machine – II
9Roto Cube Blender – II
10Tablet Compression Machine 20 Stations 
11Dedusting Machine
12Colloid Mill
13Tablet Inspection Machine
14Rapid Cota Tablet Coating Machine
15Single Track Blister Packing Machine

 RAW MATERIAL:-

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.AlfacalcidolB.P.12.500012.500 mg.
2.Calcium CarbonateB.P.25.00010.0027.500 kg.
3.Di Calcium PhosphateI.P.4.0004.000 kg.
4.ISO Propyl AlcoholI.P7.5007.500 kg.
5.Instacoat WhiteI.P.0.7000.700 kg.
6.LactoseI.P.1.5001.500 kg.
7.M.C.C.PI.P.5.0005.000 kg.
8.Magnesium StearateI.P.0.1500.150 kg.
9.Methylene ChlorideI.P.13.00013.000 kg.
10.PVPK – 30I.P.0.2500.250 kg.
11.Sodium BenzoateI.P.0.2500.250 kg.
12.StarchI.P.3.0003.000 kg
13.StarchI.P.2.5002.500 kg.
14.StarchI.P.1.0001.000 kg.
15.TalcumI.P.0.5000.500 kg.

PACKING MATERIAL:- 

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

RECORD

TOTAL QUANTITY USED
1.92 MM MILKY PVC7.0007.000 KG
2.ADHESIVE TAPE ROLL BROWN1.0001.000 NOS
3.ALUMINIUM FOIL1.5001.500 KG
4CELLO TAPE1.0001.000 NOS
5UNIT CARTON   (1 X 10)5000.0002.0005002.00 NOS
6OUTER CARTON  (5 X 10)1000.0002.0001002.000 NOS
7CORRUGATED BOXES10.00010.000 NOS

MANUFACTURING SPECIFICATION:

Moisture content of powder should be less than 2.0 %.

Average weight of each Tablet is 925 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 50,000 Tablets.

Expected Practical Yield is 50,000 + 2% Tablets.

Packing Details:

Use PVC 84 mm transparent and Aluminium foil for blister packing.

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

Put 1 strip each containing 10 tablets in each inner carton.

Put such 5 inner cartons in each outer carton.

Seal each outer carton from both ends with cello tape.

Pack 100 outer cartons in specified corrugated box S-11 to give a pack size of 100 x 5 x 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 0.250 kg of Sodium Benzoate in 1Ltr of DM water and stir continuously.

Add 1.0 kg of Starch in 2 Ltrs DM water and stir continuously to make smooth slurry.

Take 16 Ltrs of boiling water add the solution of sodium benzoate and 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 15 minutes and collect in Stainless Steel Container.

  • 5.000 kg of M.C.C.P.
  • 1.500 kg of Lactose.
  • 3.0 kg of Starch.
  • 4.00 kg of Di Calcium Phosphate.
  • 27.50 kg of Calcium Carbonate

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 45 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:

Dissolve 12.5 mg of Alfacalcidol in 100 ml Spirit Chloroform. Then mix it in geometric proportion with 2.5kg of Starch properly in double polythene bag manually.

Now add the following lubricating agents to the Roto Cube Blender and operate it as per SOP for 45 minutes. Collect the blended powder in Stainless Steel Container:

  • 0.500 kg of Talcum
  • 0.150 kg of Magnesium Stearate
  • Mixture of Starch and Alfacalcidol

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 20 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 0.700 kgs of Instacoat white in 7.5 kgs of Isopropyl Alcohol. Then add 13.0 kgs of Methylene   chloride to this solution. Collide the solution by colloidal mill as per its SOP No. 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 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 Assistant 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: I) Intermittently weight variation of compressed tablets should be checked at 30 minutes interval by the Assistant 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 Standard Operating Procedure 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 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 tablet.

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’.

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Tablets, MASTER FORMULAS

Sildenafil Citrate Tablets: A Comprehensive Guide to Understanding Uses, Dosage, and Precautions

Posted on By ABHA

Sildenafil Citrate Tablets 50 mg: A Comprehensive Guide to Understanding Uses, Dosage, and Precautions

Sildenafil citrate tablets are widely recognized for their role in the treatment of erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). This medication, commonly known by its brand name Viagra, has transformed the lives of millions of men worldwide. In this comprehensive blog post, we will explore various aspects of Sildenafil Citrate Tablets, including their uses, mechanism of action, dosage guidelines, potential side effects, precautions, and other essential information to help you gain a better understanding of this commonly prescribed medication.

Overview of Sildenafil Citrate

Sildenafil citrate is a phosphodiesterase type 5 (PDE5) inhibitor that works by relaxing the smooth muscles and increasing blood flow to specific areas of the body. It was initially developed as a cardiovascular medication but was later discovered to have a significant impact on erectile function.

Uses of Sildenafil Citrate Tablets:

Sildenafil citrate tablets are primarily used to treat erectile dysfunction in men. Additionally, sildenafil is also approved for the treatment of pulmonary arterial hypertension (PAH) in both men and women.

Mechanism of Action and Pharmacokinetics

Mechanism of Action:

Sildenafil citrate inhibits the enzyme PDE5, leading to increase levels of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells. This results in smooth muscle relaxation, vasodilation, and improved blood flow, particularly to the erectile tissue.

Pharmacokinetics:

Sildenafil citrate is rapidly absorbed after oral administration and reaches its peak concentration in the bloodstream within one to two hours. It undergoes hepatic metabolism and has a half-life of approximately four hours.

III. Sildenafil Citrate for Erectile Dysfunction

Understanding Erectile Dysfunction:

Erectile dysfunction is a common condition characterized by the inability to achieve or maintain an erection sufficient for sexual activity. Various factors contribute to the development of ED, including underlying medical conditions, psychological factors, and lifestyle choices.

Dosage and Administration:

Sildenafil citrate tablets are available in various strengths, with the most common being 25 mg, 50 mg, and 100 mg. The recommended starting dose is typically 50 mg, taken approximately one hour before sexual activity. The dosage may be adjusted based on individual response and tolerability.

Efficacy and Factors Affecting Response:

Sildenafil citrate has been extensively studied and has shown significant efficacy in treating erectile dysfunction. Factors such as the cause of ED, overall health, concurrent medication use, and psychological factors can affect the response to sildenafil therapy.

Potential Side Effects:

Common side effects of sildenafil citrate tablets include headache, flushing, nasal congestion, indigestion, and visual disturbances. Rare but serious side effects, such as priapism (prolonged erection) and sudden hearing or vision loss, require immediate medical attention.

Sildenafil Citrate for Pulmonary Arterial Hypertension
Understanding Pulmonary Arterial Hypertension:

Pulmonary arterial hypertension (PAH) is a progressive condition characterized by high blood pressure in the arteries of the lungs. Sildenafil citrate is approved for the treatment of PAH to improve exercise capacity and delay disease progression.

Dosage and Administration:

The recommended starting dose of sildenafil citrate for PAH is typically 20 mg three times daily. The dosage may be adjusted based on individual response and tolerability. Sildenafil citrate for PAH is available in different formulations, including tablets and oral suspension.

Efficacy and Factors Affecting Response:

Sildenafil citrate has been shown to improve exercise capacity and delay disease progression in patients with PAH. However, individual responses may vary, and factors such as disease severity, concurrent medication use, and underlying conditions can influence treatment outcomes.

Potential Side Effects:

The side effects of sildenafil citrate for PAH are generally similar to those for erectile dysfunction. However, patients with PAH may be more susceptible to cardiovascular effects, such as a drop in blood pressure. Close monitoring and regular follow-up with a healthcare provider are crucial for managing potential side effects.

Precautions and Considerations

Precautions and Contraindications:

Sildenafil citrate should be used with caution in individuals with certain medical conditions, including cardiovascular disease, liver or kidney impairment, retinal disorders, or a history of priapism. It is contraindicated in combination with certain medications, particularly nitrates.

Drug Interactions:

Sildenafil citrate can interact with various medications, including nitrates, alpha-blockers, certain antifungal agents, and protease inhibitors. These interactions can lead to potentially serious adverse effects, such as severe hypotension.

Special Considerations:

Special considerations should be given to certain populations, including older adults, individuals with anatomical deformities of the penis, and patients with preexisting eye conditions. Close monitoring and appropriate dose adjustments may be necessary in these cases.

Conclusion

Sildenafil citrate tablets have revolutionized the treatment of erectile dysfunction and pulmonary arterial hypertension, significantly improving the quality of life for many individuals. As a widely prescribed medication, understanding the uses, dosage guidelines, potential side effects, and precautions associated with sildenafil citrate is crucial for both patients and healthcare providers. By adhering to recommended dosages, following precautions, and seeking medical guidance, individuals can maximize the benefits of sildenafil citrate while minimizing the risk of adverse effects. If you have any concerns or questions regarding the use of sildenafil citrate tablets, consult your healthcare provider for personalized advice and guidance.

Master Formula Record

PURPOSE: This Master Formula Record 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.

PRODUCT NAME: SILDENAFIL CITRATE TABLETS

DOSAGE FORM: TABLET

EXPIRY DATE: AFTER 24 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION: 

Each film coated Tablet contains:

Sildenafil Citrate

 Equitant to Sildenafil                                             50 mg

EQUIPMENTS TO BE USED:

Steam Jacketed Starch Paste Preparation Tank
Sifter Machine – I
Roto Cube Blender –I
Rapid Mixer Granulator
Multi Mill
Fluidized Bed Drier
Oscillating Granulator
Sifter Machine – II
Sifter Machine – III
Roto Cube Blender – II
Roll Compactor Machine
Tablet Compression
Tablet Compression Machine 27 Stations
Dedusting Machine
Tablet Inspection Machine
Colloidal Mill
Rapid Coat Tablet Coating Machine
Single Track Blister Packing Machine

RAW MATERIAL:-

Aerosil : 0500 Kg

D.C.P : 25.000 Kg

Iso Propyl Alcohol :16.500 Kg

Isopropyl Alcohol :8.000 Kg

Indigo Carmine Al Lake :0.017 Kg

Instacoat Indigo Carmine :2.100 Kg

Lactose :5.899 Kg

Micro Crystalline Cellulose Phosphate :8.500 Kg

Magnesium Stearate :0.756 Kg

Methylene Chloride :30.000 Kg

Sodium Benzoate :0.077 Kg

Sodium Starch Gycolate :1.000 Kg

Starch :1.500 Kg

Sildenafil Citrate :10.774 Kg

Talcum :1.000 Kg

Instacoat Brilliant Blue :0.709 Kg

PVPK-30 :0.500 Kg

PACKING MATERIAL:-

  •  104 MM CLEAR (PVC)
  • ADHESIVE TAPE ROLL
  • CELLO TAPE
  • CORRUGATED BOX
  • OUTER CARTON
  • UNIT CARTON
  • ALUMINIUM FOIL
  • INSERT

MANUFACTURING SPECIFICATION:

Moisture content of powder should be less than 2.0 %.

Average weight of each Tablet is 350 milligrams.

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

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 30 minutes.

Mix the batch, compress and de-dust the tablets and also perform the primary packing of Tablets at temperature not more than 250

Yield:

Theoretical Yield is 7.12 Lac Tablets.

Expected Practical Yield is 7.12 Lac + 2% Tablets.

Packing Details:

Use PVC 110 mm Clear and Aluminium foil for blister packing.

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

Put 10 strips each containing 3 tablets in each carton.

Seal the each carton from both ends with cello tape.

Pack such 10 cartons in specified small-corrugated box D-46S. Seal each corrugated boxes with adhesive tape.

Pack such 12 corrugated boxes in specified corrugated box D-46 to give a pack size of 120 x 10 x 3 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 0.178 kgs of Sodium Benzoate in 1 Ltr of Purified water and stir continuously.

Add 3.489 kgs of Starch in 7.0 Ltrs Purified  water and stir continuously to make slurry.

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

Sifting:

Fit the mesh #40 Stainless Steel Sieve on the Sifter-I as per its SOP.

Sift all the 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.

  • 55.180 kgs of Di Calcium Phosphate
  • 19.580 kgs of Lactose
  • 14.240 kgs of M.C.C.P

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.

Divide the blended powder in 5 equal parts.

Divide the prepared starch paste in 5 equal parts.

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

Similarly mix another part 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 600 – 700 C for 30 minutes. Cool the granules to achieve room temperature.

Sifting:

Fit the mesh # 14 Stainless Steel Sieve 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 and above compacted material together along the following ingredients in Roto Cube Blender by operating it as per its SOP for 15 minutes and collect in Stainless Steel Container.

  • 1.780 kgs of Magnesium Stearate
  • 1.780 kgs of Talcum
  • 0.890 kgs of Sodium Starch Glycolate

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 tablets by operating it as per its SOP  and collect the selected tablets in Stainless Steel Container. 

Coating of the tablet:

Dissolve 3.987 kgs of Instacoat Indigo Carmine in 32.432 kgs of Isopropyl Alcohol. Then add 118.976 kgs of Methylene chloride to this solution. Collide the 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 tablets by operating it as per its SOP.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 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 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 Assistant 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: I) Intermittently weight variation of compressed tablets should be checked at 30 minutes interval by the Assistant 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 Standard Operating Procedure 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’.

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Tablets, MASTER FORMULAS

Pharma WhatsApp Groups for Latest Pharma Jobs, Pharma news and Pharma Post

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Capsules, DRY POWDER, Dry Syrup, EXTERNAL PREPARATION, MASTER FORMULAS, OINTMENT, Ointments, Oral Liquid, Tablets

MFR of FOOT PROTECT CREAM

Posted on By ABHA

FOOT PROTECT CREAM

PURPOSE: This Master formula Record 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:

  1. Master Copy: Manager Quality Assurance
  2. Copy No. 1: Production Pharmacist
  3. Copy No. 2: Manager Quality Control
  4. Copy No. 3: Ointment Section

PRODUCT NAME:FOOT PROTECT CREAMBATCH SIZE:  300 KG
PRODUCT REFERENCE CODE: O-19UNIT SIZE:  25g
GENERIC NAME: N.A.PACK SIZE:  30 ´ 12 ´ 25g
DOSAGE FORM: OINTMENTSTRENGTH: N.A.
DEPARTMENT:  OINTMENT DEPARTMENTEXPIRY DATE: AFTER 24 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION: 

UreaI. P.10% w/w
Lactic AcidI. P.10% w/w
Propylene GlycolI. P.10% w/w
Liquid ParaffinI. P.10% w/w

EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1Wax Vessel
2Water Vessel
3Mixing Vessel
4Colloidal Mill
5Storage Container-I (500 Kg)
6Semiautomatic Tube Filling & Sealing Machine

RAW MATERIALS:-

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1.CETO MACROGOL  – 1000I.P.3.000 KG3.000 KG
2.CETOCETYL ALCOHOLI.P.6.000 KG6.000 KG
3LACTIC ACIDI.P.30.000 KG13.3434.002 KG
4.LIQUID PARAFFIN LIGHTI.P.30.000 KG30.000 KG
5METHYL PARABEN (PLAIN)I.P.0.300 KG0.300 KG
6PEG – 4000I.P.103.000 KG103.000 KG
7PEG – 400I.P.65.000 KG65.000 KG
8P.G.I.P.30.000 KG30.000 KG
9PROPYL PARABEN (PLAIN)I.P.0.150 KG0.150 KG
10UREAI.P.30.000 KG30.000 KG

PACKING MATERIALS: –

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

RECORD

TOTAL QUANTITY USED
1.ADHESIVE TAPE ROLL1.0001.000 NOS
2CELLO TAPE1.0001.000 NOS
3CORRUGATED BOX D – 1733.00033.000 NOS
4PLASTIC TUBES12.000.0012000.00 NOS
5UNIT CARTON12000.0003.0012003.00 NOS
6OUTER CARTON1000.0002.001020.00 NOS

MANUFACTURING SPECIFICATIONS:

 Average fill of each Tube is 25 grams.

Weight variation limit allowed in each filled Tube is + 200 mg.

Melt the waxes at the maintained temperature 70˚ C.

Colloid the cream till uniform particle size is achieved.

The temperature of primary area should not exceed 30˚C.

 Yield:

Theoretical Yield is 12000 Tubes.

Expected Practical Yield is 12000 + 2% Tube.

Packing Details:

Transfer the cream from storage tank to Semiautomatic Lami Tube Filling & Sealing Machine and start filling and then sealing of the tubes as per its SOP.

Pack the filled tubes in unit cartons.

Pack such 12 tubes in each outer carton.

Seal the outer carton with cello tape.

Pack the 30 outer cartons in specified corrugated box to give a pack size of 30 x 12 x 25g tubes.

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

MANUFACTURING PROCESS:

 Melt 3.0 kg of Ceto Macrogol- 1000, 6.0 kg of Cetocetyl Alcohol, 30 kg of Liquid Paraffin Light and 103 kg of PEG-4000 in a Steam Heat Wax Melting Vessel by operating it as per its SOP at temperature 70˚

Heat 20 .0 kg of PEG- 400 and transfer it to the mixing vessel after filtering it.

Filter and transfer the melted base through Stainless Steel Sieve no. 100 to the mixing vessel and start the machine

as per its SOP.

Heat 3.0 kg of PG to 60˚ C and dissolve 0.300 kg of Methyl Paraben and 0.150 kg of Propyl Paraben in it and transfer it to the bulk batch.

Take 34.002kg of Lactic Acid, 45.0 kg of PEG-400 and 27.0kg of PG. Add 30.0kg of urea to it gradually and pass it through Colloid Mill to achieve the slurry of uniform particle size by operating it as per its SOP and transfer it to the bulk batch.

Cool the cream to the room temperature by running the water in the jacket of Mixing Vessel.

Mix the whole batch for 4.5 hours.

Send the sample to Quality Control Department for bulk testing.

After approval from Quality Control Department, transfer the cream to the storage tank.

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.

The total weight of bulk ointment / cream should be checked in the presence of  Manufacturing Chemist and record the same in Batch Manufacturing Record.

pH of the bulk should be checked and it should be with in specified limits.

Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.

While the tube filling operation is on, the Manufacturing Chemist should check weight of net filled quantity per tube at the interval of 30 minutes by checking the tare weight of empty tube and gross weight of the filled tube. Record for the same should be kept in Batch Manufacturing Record.

The ‘fill weight’ of ointment or cream per tube should not be less than the labelled amount.

Limit for Weight Variation:  Weight claimed on the carton + 200 mg

Manufacturing Chemist will also ensure that the crimping of the filled Aluminium tubes, sealing of plastic tubes is appropriate and embossing of batch number and manufacturing date is conspicuous. Also the quality of embossing will be controlled by adjusting pressure exerted by the jaws, so that pinholes are not developed on the embossed letters / numbers.

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

Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of inner cartons are being packed in each outer cartons and also the correct number of outer 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 filling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.

It will be ensure that filling or packaging equipment has been properly cleaned.

Filling or packaging of next product should be commenced only after getting the ‘Line Clearance’ of the previous product, from the IPQA.

MFR OF VITATONE SYRUP

Ointments

MFR OF MUTIVITAMIN SYRUP

Posted on By ABHA

MFR OF MUTI-VITAMIN SYRUP

PURPOSE: This Master Formula Record 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 Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager and cGMP Administrator 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 : cGMP Administrator
  5. Copy No. 4 : Liquid Section

PRODUCT NAME: MUTIVITAMIN SYRUPBATCH SIZE:  2000 LTRS.
PRODUCT REFERENCE CODE: UNIT SIZE:  300 ml
GENERIC NAME: N.A.PACK SIZE:  30 x 300 ml
DOSAGE FORM: SYRUPSTRENGTH: N.A.
DEPARTMENT:  LIQUID DEPARTMENTEXPIRY DATE: AFTER 18 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION: Each 15 ml contains:

Vitamin A (as Palmitate)   I.P.2500  I.U.
NiacinamideI.P.20 mg
Vitamin D3 I.P.200 I.U.
D-PanthenolI.P.5 mg
Thiamine Hydrochloride I.P.1.5 mg
BiotinU.S.P.30 mcg
Riboflavin Sodium Phosphate Iodine (as Potassium Iodide I.P.) Equ.to  Riboflavin   I.P.  1.7  mgI.P.150 mcg
Iron  (as Ferrous Gluconate I.P.)I.P.  9 mg
Pyridoxine Hydrochloride I.P. 1.5 mg
Zinc (as Zinc Gluconate U.S.P.)U.S.P.3 mg
Vitamin B12  I.P.1 mcg
Manganese (as Manganese Chloride U.S.P.)U.S.P.2.5mg
Vitamin CI.P.50 mg
Chromium  (as Chromium Chloride U.S.P.)U.S.P.25 mcg
Vitamin E Acetate  I.P.10 I.U.
Molybdenum (as Sodium Molybdate U.S.P.)U.S.P.25 mcg

List Of Equipments

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

3Charging Tank – V – 3500 Ltrs.
4Filter Press
5Storage Tank – III – 3500 Ltrs
6Linear Bottle Washing Machine
7Digi Pack Bottle Filling and Sealing Machine
8Automatic Bottle Labelling Machine

Raw Material Details

S.NO.INGREDIENTS Theoretical Quantity Req.Overages %Total Quantity Used
1.ASPARTUM0.3000.300 KGS.
2.ASPARTUM (P)2.0002.000 KGS.
3.BRONOPOL1.0001.000 KGS.
4.CHROMIUM CHLORIDE17.10015.0019.665 GMS.
5.D – PANTHENOL0.67020.000.804 KGS.
6.D – BIOTIN4.00050.006.000 GMS.
7.FERRIC  AMMONIUM CITRATE6.00010.006.600 KGS.
8.GLYCERINE200.000200.000 KGS.
9.SUGAR700.000700.000 KGS
10.LEMON FLAVOUR2.0002.000 LTRS.
11.LIQUID GLUCOSE800.000800.000 KGS.
12.MANGANESE CHLORIDE1200.00015.001380.000 GMS.
13.NIACINAMIDE2.66820.003.202 KGS.
14.ORANGE FLAVOUR2.0002.000 LTRS.
15.POTASSIUM IODIDE0.02615.000.030 KGS.
6.PINEAPPLE FLAVOUR2.0002.000 LTRS.
17.SODIUM   BISULFITE2.0002.000 KGS.
18.SODIUM MOLYBDATE8.41615.009.678 GMS.
19.TWEEN – 8020.00020.000 KGS.
20.VITAMIN A – PALMITATE0.19675.000.343 KGS.
21.VITAMIN – B1 HCL0.20060.000.320 KGS.
22.VITAMIN B2 – 5  PHOSPHATE0.31050.000.465 KGS.
  23.VITAMIN – B6 HCL0.20030.000.260 KGS.
24.VITAMIN – D30.666100.001.332 GMS.
25.VITAMIN – B120.134100.000.268 GMS.
26.VITAMIN – C (PLAIN)6.66825.008.335 KGS.
27.VITAMIN – E (ACETATE)1.33225.001.665 KGS.
28.ZINC GLUCONATE3.06015.003.519 KGS.

 Packing Material Details

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

RECORD

TOTAL QUANTITY USED
1.300 ML AMBER ROUND DANDA BTLS6666.6666666.666
2.ADHESIVE TAPE ROLL BROWN3.0003.000 NOS
3.CORRUGATED BOXES V – 40222.222222.222 NOS
4.GUM ACCACIA1.0001.000 KGS
5PILFER PROOFS  – 25 MM6666.6666666.666 NOS
6LABEL6888.8883.0006891.888 NOS
7DIBBI6666.6662.006668.666 NOS

MANUFACTURING SPECIFICATION:

Average fill of each Bottle is 300 ml.

Volume variation limit allowed in each filled Bottle is 300 ml to 301 ml.

Make up the final volume of the syrup accurately.

Filter the completely charged batch using Filter Press L-21 by operating it as per its SOP.

Transfer the syrup from charging tank L-10 to storage tank L-14 after complete charging of batch.

Mix the batch, Fill the bottles and also perform the primary packing of bottles at temperature not more than 250 C and Relative Humidity not more than 40.

Yield:

Theoretical Yield is 6666 Bottles.

Expected Practical Yield is 6666 + 2% Bottles.

Packing Details:

Wash the bottles on Linear Bottle Washing Machine L-24 and operate it as per its SOP.

Transfer the Syrup from storage tank to Digipack Bottle Filling and Sealing Machine L-25 for filling and sealing of the bottles as per its SOP.

Fill 300 ml syrup in 300 ml amber glass round bottle and use 25 mm PP Cap to seal the bottle mouth.

Inspect the each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.

Label every inspected bottle by using the Automatic Bottle Labelling Machine L-26.

Pack each filled and sealed bottle in unit carton individually.

Pack the 30 unit cartons in specified corrugated box V-40 to give a pack size of 30 x 300 ml.

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

MANUFACTURING PROCESS:

Add 1000.0 kgs of Invert Sugar through transfer pump to the charging tank.

Add 800.0 kgs of Liquid Glucose through transfer pump to the charging tank.

Add 200.0 kgs of Glycerine through transfer pump to the charging tank.

Preparation of Vitamin A and Vitamin D3 Emulsion:

Heat 20.0 kgs of Tween – 80 in a Stainless Steel Containers upto 600 C and transfer it to Mixer. Add 0.343 kgs Vitamin A Palmitate, 1.665 kgs of Vitamin E Acetate and 1.332 gms of Vitamin D3 to the Mixer and stir it vigoursly for half an hour.

Add previously heated Purified water maintained at 600 C in 2:1 ratio to the mixer and stir it for 30 minutes continuously.

Addition of Ingredients into the Charging Tank  while stirring continuously:       

Dissolve 1.0 kgs of Bronopol in 10 Ltrs of  Purified water and add to the bulk batch.

Dissolve 2.0 kgs of Sodium Bi Sulphite in 10 Ltrs of Purified water.

Dissolve 0.300 kgs of Aspartum in 1 Ltrs of  Purified water and add to the bulk batch.

Dissolve 2.0 kgs of Aspartum (P) in 15 Ltrs of hot Purified water and add to the bulk batch.

Dissolve 3.082 kgs of Niacinamide in 15 Ltrs of Purified water and add to the bulk batch.

Dissolve 0.771 kgs of D – Penthenol in 4 Ltrs of Purified water and add to the bulk batch.

Dissolve 0.320 kgs of Vitamin B1 HCl in 1 Ltrs of Purified water and add to the bulk batch.

Dissolve 0.260 kgs of Vitamin B6 HCl in 2 Ltrs of Purified water and add to the bulk batch.

Dissolve 0.268 gms of Vitamin B12 in 2 Ltrs of Purified water and add to the bulk batch.

Dissolve 18.480 kgs of Zinc Gluconate in 100 Ltrs of Purified water and add to the bulk batch.

Dissolve 6.0 gms of D – Biotin in 3 Ltrs of hot Purified water and add to the bulk batch.

Dissolve 18.810 gms of Chromium Chloride in 3 Ltrs of hot Purified water and add to the bulk batch.

Dissolve 1320.0 gms of Manganese Chloride in 10 Ltrs of hot Purified water and add to the bulk batch.

Dissolve 0.029 kgs of Potassium Iodide in 1 Ltrs of hot Purified water and add to the bulk batch.

Dissolve 9.342 gms of Sodium Molybdate in 2 Ltrs of hot Purified water and add to the bulk batch.

Dissolve 6.6 kgs of Ferric Ammonium Citrate in 40 Ltrs of Purified water and add to the bulk batch.

Dissolve 0.434 kgs of Vitamin B2 Phosphate in 10 Ltrs of Purified water.

Dissolve 7.668 kgs of Vitamin C in 30 Ltrs of hot Purified water.

Add Vitamin A Palmitate, Vitamin E Acetate and D3 Emulsion prepared in step II to the bulk batch.

Add 2.0 Ltrs of Orange Flavour, 2.0 Ltrs of Lemon Flavour and 2.0 Ltrs of Pineapple Flavour to the bulk batch.

Make up the volume with Purified water and mix until homogeneous.

Check the pH of Solution to be in between 4.0 – 5.0.

Filter the batch through Filter Press  by operating it as per its SOP  and transfer it to the Storage Tank .

Send the sample to Quality Control Department for bulk testing.

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.

Final volume should be made as per Standard Operating Procedure using correct dipstick in the Manufacturing Chemist.

pH of the bulk should be checked and it should be with in specified limits.

Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.

Intermittently filled volume should be checked at 30 minutes interval by the  Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.

The net volume should be checked for all the filling nozzles and in no case, net volume should be less than volume claimed on the label.

Limit for Volume Variation:  Volume claimed on the label + 2ml

Visual inspection of filled and sealed bottles should be done as per SOP  and the record of  the same should be kept in the Batch Manufacturing Record.

Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.

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

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

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

It will be ensure that filling or packaging equipment has been properly cleaned.

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

MFR of Paracetamol & Dicyclomine HCl Tablets

 

Oral Liquid, MASTER FORMULAS