Terms and Conditions

MFR of Pantoprazole Sodium Sesquihydrate Injection

Byiamraj

Oct 22, 2020 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,
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  INJECTION PACK SIZE: 6X40 mg
DOSAGE FORM: PARENTERAL DOSAGE FORM STRENGTH: 40.0mg
DEPARTMENT:  STERILE PREPARATION EXPIRY 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
2 Semi Auto Vial  Washing Machine
3 Auto Clave with SS Transfer trolley
4 Dry Heat Sterilizer
5 Double Cone Blender Machine
6 Auto Dry Powder Vial Filling, Stoppering & Sealing Machine
7 Semi Auto Vial Visual Inspection Machine
8 Auto Vial Labelling Machine

RAW MATERIALS:

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

RECORD

TOTAL QUANTITY USED
1. 10ML CLEAR VIALS 10000.000 10000.000
2. FLIP OFF SEALS RED –13MM 10000.000 10000.000NOS
3. RUBBER STROPPER-20MM 10000.000 10000.000 NOS
4. ADHESIVE TAPE ROLL BROWN 2.000 2.000 NOS
5. CELLO TAPE 2.000 2.000 NOS
6. GUM ACCACIA 0.500 0.500KG
7. CORRUGATED BOXES C-37 75.750 75.750 NOS
8. PANTOMAC-40MG INJ INSERT 10000.000 2.000 10002.000 NOS
9. PANTOMAC-40MG UNIT CARTON 10000.000 2.000 10002.000NOS
10. PANTOMAC-40MG LABEL 10100.000 3.000 10103..000NOS
11. PANTOMAC-40MG 6X40 mg OUTER CARTON 1667.850 1667.850NOS
12. PL TRAY(10ML VIAL + 10ML AMPS) 10000.000 10000.000NOS

PACKING MATERIALS:

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

RECORD

TOTAL QUANTITY USED
1. 10ML CLEAR VIALS 10000.000 10000.000
2. FLIP OFF SEALS RED –13MM 10000.000 10000.000NOS
3. RUBBER STROPPER-20MM 10000.000 10000.000 NOS
4. ADHESIVE TAPE ROLL BROWN 2.000 2.000 NOS
5. CELLO TAPE 2.000 2.000 NOS
6. GUM ACCACIA 0.500 0.500KG
7. CORRUGATED BOXES C-37 75.750 75.750 NOS
8. PANTOMAC-40MG INJ INSERT 10000.000 2.000 10002.000 NOS
9. PANTOMAC-40MG UNIT CARTON 10000.000 2.000 10002.000NOS
10. PANTOMAC-40MG LABEL 10100.000 3.000 10103..000NOS
11. PANTOMAC-40MG 6X40 mg OUTER CARTON 1667.850 1667.850NOS
12. PL TRAY(10ML VIAL + 10ML AMPS) 10000.000 10000.000NOS

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

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

By iamraj