MASTER FORMULA OF BURN CURE CREAM (Acriflavine & Thymol Cream)

MASTER FORMULA OF BURN CURE CREAM (Acriflavine & Thymol Cream)

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 Assistant Manufacturing Chemist to follow and adhere to this SOP. The Production, 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: BURN CURE CREAMBATCH SIZE:  500 Kg
PRODUCT REFERENCE CODE: UNIT SIZE:  20 g
GENERIC NAME: N.A.PACK SIZE:  18 ´ 20 ´ 10 g
DOSAGE FORM: OINTMENTSTRENGTH: N.A.
DEPARTMENT:  OINTMENT DEPARTMENTEXPIRY DATE: AFTER 36 MONTHS     FROM THE DATE OF MANUFACTURING

COMPOSITION:

For 100g:

AcriflavineB. P.C.630.12g
ThymolB. P.5mg

 SPECIMEN UNIT CARTON: 

 EQUIPMENTS TO BE USED: 

SR. NO.NAME OF EQUIPMENTASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1Wax Vessel
2Water Vessel
3Mixing Vessel
4Storage Container-I (500 Kg)
5Semiautomatic Aluminium Tube Filling & Crimping Machine

 RAW MATERIALS: 

S.NO.INGREDIENTS STDTheoretical Quantity Req.Overages %Total Quantity Used
1ACRIFLAVINEB.P.C.63600.00010.00660.000 GM
2CM – 1000B.P.16.66616.666 KG
3CETOCETYL ALCOHOLB.P.50.00050.000 KG
4EDTAB.P.0.5000.500 KG
5LIQUID PARAFFIN LIGHTB.P.25.00025.00 KG
6SODIUM BENZOATEB.P.2.5002.500 KG
7S.M.B.SB.P.0.5000.500 KG
8SPIRIT CHLOROFORMI.P.1.0001.000 BTLS
9THYMOLB.P.0.02060.000.032 KG
10WHITE PETROLEUM JELLYU.S.P.80.00080.000 KG

     PACKING MATERIALS: –

   S.NO.NAME OF THE MATERIAL THEORETICAL QUANTITY REQ.FOR RECORDTOTAL QUANTITY USED
1ADHESIVE TAPE ROLL BROWN2.0002.000 NOS
2UNIT CARTON25000.0003.00025003.000 NOS
3OUTER CARTON1250.002.0001252.00 NOS
4TUBES25000.00025000.000 NOS
5CELLO TAPE3.0003.000 NOS
6CORRUGATED BOXES  S – 3669000.00069000.000 NOS

MANUFACTURING SPECIFICATIONS: 

1. Average fill of each Tube is 20 grams.

2.Wight variation limit allowed in each filled Tube is + 200 mgs.

3.Melt the ointment base at the maintained temperature of 70˚ C.

4.Use accurate weight quantity of water to make up the final weight of cream.

5.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:

1. 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.

2.Pack the filled tubes in unit carton.

3.Pack such 20 tubes in each outer carton.

4.Seal the outer carton with cello tape.

5.Pack the 18 outer cartons in specified corrugated S-36 box to give a pack size of 18 x 20 x 20 g Tubes.

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

 MANUFACTURING PROCESS:

1. Melt 16.666 kgs of Ceto Macrogol- 1000, 50 kgs of Cetocetyl Alcohol, 25.0 kgs of Liquid Paraffin Light and 80.0 kgs White Petroleum Jelly in a Steam Heat Wax Melting Vessel by operating it as per its SOP at temperature 70° C.

2.Heat 324.50 kg of water at   70° C in Water Vessel by operating it as per its SOP.

3.Filter and transfer the melted base through Stainless Steel Sieve no. 100 to the mixing vessel and start the machine as per its SOP.

4.Dissolve 0.500 kg of EDTA in 4 kg of water and transfer it to the bulk batch.

5.Dissolve 0.500 kg of Sodium Metabisulphite in 4 kg of water and transfer it to the bulk batch.

6.Dissolve 2.500 kg of Sodium Benzoate in 10 kg of water and transfer it to the bulk batch.

7.Slowly add rest of water to the bulk batch.

8.Cool the cream to the room temperature by running the water in the jacket of mixing vessel.

9.Triturate 660.00 kg of Acriflavine in 7.0kgs of Liquid Paraffin Light in mortar–pestle and add to the bulk batch.

10.Dissolve 0.032 kg of thymol in 450 ml of Spirit Chloroform.

11.Mix the whole batch for 90 minutes while running the water in the jacket.

12.Send the sample to Quality Control Department for bulk testing.

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

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 materials and have ‘Released’ labels fixed on it.

2. 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.

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

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

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

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

7.While the tube filling operation is on, the Assistant 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.

8.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

9.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.

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

11. 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.

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

13. 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.

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

15.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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About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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