Master Manufacturing Formula (MFR): Burn Relief Cream
Source: drugsformulations.com via archive.org
PURPOSE
This Master Manufacturing Formula (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.
SCOPE
This MFR is performed and is applied during the manufacturing of dosage form.
RESPONSIBILITY / ACCOUNTABILITY
It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.
COPY ISSUED TO
| Master Copy: | Manager Quality Assurance |
| Copy No. 1: | Production Pharmacist |
| Copy No. 2: | Manager Quality Control |
| Copy No. 3: | Ointment Section |
PRODUCT DETAILS
| Product Name | Burn Relief Cream |
| Batch Size | 500 Kg |
| Product Reference Code | O-11 |
| Unit Size | 20 G |
| Generic Name | N.A. |
| Pack Size | 18 × 20 × 10 G |
| Dosage Form | Ointment |
| Strength | N.A. |
| Department | Ointment Department |
| Expiry Date | After 36 months from the date of manufacturing |
COMPOSITION (For 100g)
| Acriflavine | B.P.C.63 |
| Thymol | |
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 | Storage Container-I (500 Kg) | | |
| 5 | Semiautomatic Aluminium Tube Filling & Crimping Machine | | |
RAW MATERIALS
| Ingredients | Theoretical Quantity Req. | Overages % | Total Quantity Used |
|---|
| Acriflavine B.P.C.63 | 600.000 | — | 660.000 GM |
| Cetomacrogol-1000 (CM-1000) | 16.666 | — | 16.666 KG |
| Cetocetyl Alcohol | 50.000 | 0.500 | 50.000 KG |
| Liquid Paraffin Light | 25.000 | — | 25.00 KG |
| Sodium Benzoate | 2.500 | — | 2.500 KG |
| Sodium Metabisulphite (S.M.B.S.) | 0.500 | — | 0.500 KG |
| Spirit Chloroform | 1.000 | — | 1.000 BTLS |
| Thymol | 0.032 | — | 0.032 KG |
| White Petroleum Jelly U.S.P. | 80.000 | — | 80.000 KG |
PACKING MATERIALS
| Name of the Material | Theoretical Quantity Req. | Record | Total Quantity Used |
|---|
| Adhesive Tape Roll Brown | — | — | 2.000 NOS |
| Unit Carton | 25000.000 | — | 25003.000 NOS |
| Outer Carton | 1250.00 | — | 1252.00 NOS |
| PVC Film / Shrink Wrap | 25000.000 | — | 25000.000 NOS |
| Cello Tape | — | — | 3.000 NOS |
| Corrugated Boxes S-36 | 69000.000 | — | 69000.000 NOS |
MANUFACTURING SPECIFICATIONS
- 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 of 70° C.
- Use accurate weight quantity of water to make up the final weight of cream.
- The temperature of primary area should not be more than 30° C.
YIELD
| Theoretical Yield | 25,000 Tubes |
| Expected Practical Yield | 25,000 ± 2% Tubes |
PACKING DETAILS
- Transfer the cream from storage tank to Semiautomatic 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 20 tubes in each outer carton.
- Seal the outer carton with cello tape.
- Pack the 18 outer cartons in specified corrugated box to give a pack size of 18 × 20 × 10 G Tubes.
- Seal each corrugated box with adhesive tape and label it properly by affixing the specified label.
MANUFACTURING PROCESS
- Melt 16.666 kg of Cetomacrogol-1000, 50 kg of Cetocetyl Alcohol, 25.0 kg of Liquid Paraffin Light and 80.0 kg White Petroleum Jelly in a Steam Heat Wax Melting Vessel by operating it as per its SOP at temperature 70° C.
- Heat 324.50 kg 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 0.500 kg of EDTA in 4 kg of water and transfer it to the bulk batch.
- Dissolve 0.500 kg of Sodium Metabisulphite in 4 kg of water and transfer it to the bulk batch.
- Dissolve 2.500 kg of Sodium Benzoate in 10 kg of water and transfer it to the bulk batch.
- Slowly add rest of water to the bulk batch.
- Cool the cream to room temperature by running the water in the jacket of mixing vessel.
- Triturate 660.00 kg of Acriflavine in 7.0 kg of Liquid Paraffin Light in mortar-pestle and add to the bulk batch.
- Dissolve 0.032 kg of Thymol in 450 ml of Spirit Chloroform.
- 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.
IN-PROCESS CONTROLS
| Sr. No. | Control Parameter | Specification / Instruction |
|---|
| 1 | Raw Material Verification | Check raw materials used for manufacturing are all approved materials with ‘Released’ labels fixed on them. |
| 2 | Weighed Raw Materials | All weighed raw materials should be counter-checked by Assistant Manufacturing Chemist. Any discrepancy should be brought to Production Pharmacist and QC/QA Manager. |
| 3 | Physical Characteristics | Colour, odour, and consistency of raw materials are checked before compounding. |
| 4 | Total Weight Check | Total weight of bulk ointment/cream should be checked in the presence of Assistant Manufacturing Chemist and recorded in Batch Manufacturing Record. |
| 5 | pH Check | pH of the bulk should be checked and should be within specified limits. |
| 6 | Bulk Sample | Bulk sample should be sent to Quality Control Department before starting the filling and sealing stage. |
| 7 | Weight Check (During Filling) | Assistant Manufacturing Chemist should check weight of net filled quantity per tube at 30-minute intervals by checking tare weight of empty tube and gross weight of filled tube. Record in Batch Manufacturing Record. |
| 8 | Fill Weight Limit | Fill weight of ointment/cream per tube should not be less than labelled amount. Weight Variation Limit: Weight claimed on carton ± 200 mg. |
| 9 | Crimping & Embossing | Ensure crimping of filled aluminium tubes and sealing of plastic tubes is appropriate. Embossing of batch number and manufacturing date should be conspicuous. Adjust pressure by jaw adjustment so pinholes are not developed on embossed letters/numbers. |
| 10 | Carton Coding Check | Inner and outer cartons should be checked thoroughly for proper batch coding. |
| 11 | Pack Count Verification | Manufacturing Chemist and Production Pharmacist should randomly check correct number of inner cartons per outer carton and correct number of outer cartons per shipper as shown in proof. |
| 12 | QC Sampling | Intimation should be sent to Quality Control Department for finished product sampling and testing. |
| 13 | Printed Material Accounting | After completion of filling and packaging, coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction record in Batch Manufacturing Record. |
| 14 | Equipment Cleaning | Filling or packaging equipment has been properly cleaned. |
| 15 | Line Clearance | Filling or packaging of next product should be commenced only after getting ‘Line Clearance’ of the previous product from the IPQA. |
