MASTER FORMULA OF KETOCONAZOLE SHAMPOO

MASTER FORMULA OF KETOCONAZOLE SHAMPOO

PURPOSE:  This Master Formula 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: KETOCONAZOLE SHAMPOO BATCH SIZE:  1000 LTRS.
PRODUCT REFERENCE CODE: 97 UNIT SIZE:  75 ml
GENERIC NAME: N.A. PACK SIZE:  12 x 12 x 75 ML
DOSAGE FORM: SEMI LIQUID STRENGTH: N.A.
DEPARTMENT:  EXTERNAL PREPARATION EXPIRY DATE: AFTER 15 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION: 

  Ketoconazole                   I.P.          2% w/v

    EQUIPMENTS TO BE USED:

 

SR. NO. NAME OF EQUIPMENT ASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Charging Tank – E-02(1200 Lts)
2 Storage Tank – III – 5000 Ltrs
3 Manual Bottle Filling Machine
4 Semi Auto Bottle Sealing Machine
5 Semi Auto Labelling Machine
6 Shrink Packing Machine

Raw  materials  required:

 

S.NO. INGREDIENTS STD Theoretical Quantity Req. Overages % Total

Quantity Used

1 BRILLIANT BLUE COLOUR F.G. 32.000 32.000 GM
2 BASIL OIL FLAVOUR F.G. 0.300 0.300 LTR
3 CAPB I.P. 30.000 30.000  KGS
4 DRAKKAR NOIR FLAVOUR F.G. 2.000 2.000 LTR
5 FORMAL DEHYDE SOLUTION I.P. 0.800 0.800 LTR.
6 GLACIAL ACETIC ACID I.P. 2.500 2.500 KGS
7 GLYCERINE I.P. 10.000 10.000 KGS
8 G – 100 (COCO MONO) I.P. 20.000 20.000 KGS
9 KETOCONAZOLE I.P. 20.000 5.000 21.000 KGS
10 SODIUM CHLORIDE I.P. 10.000 10.000 KGS
11 SODIUM HYDROXIDE PELLET I.P. 0.750 0.750 KGS
12 S.L.E.S. I.P. 450.000 450.000 KGS

PACKING MATERIALS REQUIRED:

 

 

 

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

RECORD

TOTAL QUANTITY USED
1 100 ml Plastic Flat Btls. 13333.000 13332.000 NOS
2 6 x 20 mm Flip Top Pl. Caps 13333.000 13332.000 NOS
3 Adhesive Tape Roll Brown 4.000 4.000 NOS
4 Corrugated Box 92.000 92.000 NOS
5 Unit Carton 13333.000 2.000 13335.000 NOS
6 Label – Back 13425.000 3.000 13428.000 NOS
7 Label – Front 13425.000 3.000 13428.000 NOS
8 Shrink Film 1110.00

 

1110.00 NOS

MANUFACTURING SPECIFICATION:

  1. Average fill of each Bottle is 75 ml.
  2. Volume variation limit allowed in each filled Bottle is 75 ml to 77 ml.
  3. Make up the final volume of the shampoo accurately.
  4. Transfer the shampoo from charging tank E – 02 to storage tank E-03 after complete charging of batch.

Yield:

  • Theoretical Yield is 13333 Bottles.
  • Expected Practical Yield is 13333 + 2% Bottles.

Packing Details:

  1. Transfer the Shampoo from charging tank to manual filling machine for filling of the bottles as per its SOP.
  2. Fill 75 ml of shampoo in white plastic flat bottle and seal every bottle with flip off top cap.
  3. Label every filled and closed bottle, from both front and backside, manually.
  4. Pack each filled and labelled bottle in unit carton individually.
  5. Make a group of 12 bottles packed in unit cartons.
  6. Wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Packing Machine  as per its SOP.
  7. Pack such 12 shrinked packets in the corrugated box. Thus each corrugated box contains 12 x 12 x 75 ml filled and sealed bottles.
  8. Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.

MANUFACTURING PROCESS: 

  1. Add 450 kgs of S.L.E.S. in the steam jacketed charging tank .
  2. Add 200 kgs of Purified water to it.
  3. Now slowly heat at 70 oC  by running the steam in the jacket of the tank.
  4. Add 2.5 kgs of the Glacial Acetic Acid into the tank.
  5. Slowly add 21 kgs of Ketoconazole under constant stirring to the bulk batch.
  6. Maintain the temperature at 70 0C  and it should not exceed at any stage.
  7. Keep on mixing till baby colour is achieved and Ketoconazole is completely dissolved.
  1. II) Addition of Ingredients into the Charging Tank E – 02 while stirring continuously:
  2. Melt 30.0 kgs of C.A.P.B. in Stainless Steel Container and add to the bulk batch.
  3. Allow the batch to cool at 40 0C by stopping the steam supply.
  4. Add 20.0 kgs of G – 100 to the bulk batch.
  5. Add 10.0 kgs of Glycerine to the bulk batch.
  6. Dissolve 0.750 kgs of Sodium Hydroxide Pellets in 10 Ltrs of Purified water and add to the bulk batch.
  7. Add 0.800 Ltrs of Formaldehyde Solution to the bulk batch.
  8. Dissolve 10.0 kgs of Sodium Chloride in 25 Ltrs of D.M. water and add to the bulk batch.
  9. Add 0.300 Ltrs of Basil Oil Flavour and 2.0 Ltrs of Drakkar Noir Flavour to the bulk batch.
  10. Dissolve 32.0 Gms of Brilliant Blue colour in 3 Ltrs of hot D.M. water and add to the bulk batch.
  11. Stop stirring and make up the volume.
  12. Leave aside the batch for 24 hours so that the foaming ceases.
  13. After 24 hours again check the volume and make it up. Stir the batch and leave it for 12 hours.
  14. Send the sample to Quality Control Department for bulk testing.

IN-PROCESS CONTROLS:

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

  1. Check Raw materials used for manufacturing purpose are all approved 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  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 using correct dipstick in the Assistant Manufacturing Chemist.
  5. pH of the bulk should be checked and it should be with in specified limits of pH 6.0 to 7.0.
  6. Only after receiving the Bulk Test Report from Q.C. Dept. start filling the shampoo in bottles and seal them properly.
  7. The Manufacturing Chemist should check intermittently filled volume at 30 minutes interval and 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, net volume should be less than volume claimed on the label.

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

  1. 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.
  2. Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.
  3. The labels and cartons should be checked thoroughly for proper batch coding.
  4. Intimation should be sent to Quality Control Department for finished product sampling and testing.
  5. 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.
  6. It will be ensure that filling or packaging equipment has been properly cleaned.
  7. Filling or packaging of next product should not commence until the IPQA has given the ‘Line Clearance’.

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