Clotrimazole Ointments
PURPOSE: This Master formula record (MFR) 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 are accountable for the strict adherence to the master formula.
COPY ISSUED TO:
Master Copy : Manager Quality Assurance
Copy No. 1 : Production Pharmacist
Copy N0 2 : Manager Quality Control
Copy No. 3 : Ointment Section
| PRODUCT NAME: Clotrimazole | BATCH SIZE: 500 Kg |
| PRODUCT REFERENCE CODE: | UNIT SIZE: 20g |
| GENERIC NAME: N.A. | PACK SIZE: 24 ´ 12 ´ 20g |
| DOSAGE FORM: OINTMENT | STRENGTH: N.A. |
| DEPARTMENT: OINTMENT DEPARTMENT | EXPIRY DATE: AFTER 36 MONTHS FROM THE DATE OF MANUFACTURING |
COMPOSITION:
| Clotrimazole | B. P. | 1% w/w |
EQUIPMENTS TO BE USED:
| SR. NO. | NAME OF EQUIPMENT | ASSEMBLING AS PER SOP NO. | CLEANING AS PER SOP NO. | ||
| 1 | Wax Vessel | ||||
| 2 | Water Vessel | ||||
| 3 | Mixing Vessel | ||||
| 4 | Colloidal Mill | ||||
| 5 | Storage Container-I (1000 Kg) | ||||
| 6 | Semiautomatic Tube Filling & Crimping Machine | ||||
RAW MATERIALS:-
| S.NO. | INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total Quantity Used |
| 1. | CETO MACROGOL- 1000 | B.P. | 16.667 KG | 16.667 KG | |
| 2. | CETOCETYL ALCOHOL | B.P. | 50.000 KG | 50.000 KG | |
| 3. | CLOTRIMAZOLE | B.P. | 5.000 KG | 5.00 | 5.250 KG |
| 4. | LIQUID PARAFFIN LIGHT | B.P. | 25.000 KG | 25.000 KG | |
| 5 | METHYL PARABEN SODIUM | U.S.P. | 0.750KG | 0.750 KG | |
| 6 | PROPYL PARABEN SODIUM | U.S.P. | 0.25 KG
| 0.25KG | |
| 7 | SODIUM METABISULPHITE | B.P. | 1.667 KG | 1.667 KG | |
| 8 | WHITE PETROLEUM JELLY | U.S.P | 80.000 KG | 80.000 KG |
| S.NO. | NAME OF THE MATERIAL | THEORETICAL QUANTITY REQ. | FOR RECORD | TOTAL QUANTITY USED |
| 1. | ADHESIVE TAPE ROLL | 2.000 | 2.000 NOS | |
| 2. | CELLO TAPE | 5.000 | 5.000 NOS | |
| 3. | TUBES – 20 G | 25000.000 | 25000.00 NOS | |
| 4. | UNIT CARTON | 25000.000 | 3.000 | 25003.00 NOS |
| 5 | OUTER CARTON | 2083.00 | 2.000 | 2085.00 NOS |
| 6 | CORRUGATED BOXES | 87.000 | 87.000 NOS |
PACKING MATERIALS:-
MANUFACTURING SPECIFICATION:
Average fill of each Tube is 20 grams.
Weight variation limit allowed in each filled Tube is + 200 mg.
Melt the ointment base at the maintained temperature 70˚C.
Use accurate weighed quantity of water to make up the final weight of cream
Colloid the cream till uniform particle size is achieved.
The temperature of primary area should not be more than 30˚C.
Yield:
Theoretical Yield is 25000 Tubes.
Expected Practical Yield is 25000 + 2% Tube.
Packing Details:
Transfer the cream from storage tank to Aluminium Tube Filling & Crimping Machine and start filling and then Crimping of the tubes as per its SOP .
Pack the filled tubes in unit carton.
Pack such 12 tubes in each outer carton.
Seal the outer carton with cello tape.
Pack the 24 outer cartons in specified corrugated box to give a pack size of 24 x 12 x 20g tubes.
Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.
MANUFACTURING PROCESS:
Melt 16.666 kg of Ceto Macrogol- 1000, 50 kg of Cetocetyl Alcohol, 25 kg of Liquid Paraffin Light, 80 kg of White Petroleum Jelly in a Steam Heat Wax Melting Vessel by operating it as per its SOP at temperature 70°
Heat 321.0kg of water at 70° C in Water Vessel by operating it as per its SOP.
Filter and transfer the melted base through Stainless Steel Sieve no. 100 to the Mixing Vessel and start the machine as per its SOP.
Dissolve 0.750 kg of Methyl Paraben Sodium in 2.0kg of hot water and transfer it to the bulk batch.
Dissolve 0.250 kg of Propyl Paraben Sodium in 4.0kg of hot water and transfer it to the bulk batch.
Dissolve 1.666 kg of Sodium Metabisulphite in 6.0kg of hot water and transfer it to the bulk batch.
Take 30 kg of hot water and suspend 5.25 kg of Clotrimazole 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.
Slowly add rest of water 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 90 minutes while running the water in the jacket.
Send the sample to Quality Control Department for bulk testing.
After approval from Quality Control Department, transfer the cream to storage tank.
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 Quality Control Analyst.
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