MASTER FORMULA OF Ciprofloxacin, Fluocinolone and Clotrimazole Cream 

MASTER FORMULA OF Ciprofloxacin, Fluocinolone and Clotrimazole 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  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:     Ointment Section

PRODUCT NAME: Ciprofloxacin, Fluocinolone and Clotrimazole Cream BATCH SIZE:  300 KG
PRODUCT REFERENCE CODE: O-15 UNIT SIZE:  10g
GENERIC NAME: N.A. PACK SIZE:  36 ´ 12 ´ 10g
DOSAGE FORM: OINTMENT STRENGTH: N.A.
DEPARTMENT:  OINTMENT DEPARTMENT EXPIRY DATE: AFTER 24 MONTHS FROM THE DATE OF MANUFACTURING

COMPOSITION:

Ciprofloxacin Hydrochloride I. P.
equivalent to Ciprofloxacin I. P. 0.5 % w/w
Fluocinolone Acetonide I. P. 0.025% w/w
Clotrimazole I. P. 1.0% w/w

SPECIMEN OF UNIT CARTON: 

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 (500 Kg)
6 Semiautomatic Tube Filling & Crimping Machine

 RAW MATERIALS:-

S.NO. INGREDIENTS STD Theoretical Quantity Req. Overages % Total Quantity Used
1. CETO MACROGOL  – 1000 I.P. 10.000 KG 10.000 KG
2. CETOCETYL ALCOHOL I.P. 30.000 KG 30.000 KG
3 CIPROFLOXACIN HCL I.P. 1.500 KG 22.00 1.830 KG
4. CLOTRIMAZOLE I.P. 3.000 KG 5.00 3.150 KG
5 EDTA I.P. 0.3000 KG 0.300 KG
6 FLUOCINOLONE ACETONIDE I.P. 75.000 G 4.00 78.000 G
7 LIQUID PARAFFIN LIGHT I.P. 15.000 KG 15.000 KG
8 METHYL PARABEN SODIUM I.P. 0.600 KG 0.600 KG
9 PROPYL PARABEN SODIUM I.P. 0.300KG 0.300 KG
10 SODIUM METABISULPHITE I.P. 0.600 KG 0.600 KG
11 WHITE PETROLEUM JELLY U.S.P. 48.000 KG 48.000 KG

 PACKING MATERIALS:-

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

RECORD

TOTAL QUANTITY USED
1. ADHESIVE TAPE ROLL BROWN 3.000 3.000 NOS
2. CELLO TAPE 4.000 4.000 NOS
3. TUBE – 10 GM 30000.000 30000.000 NOS
4. UNIT CARTON 30000.000 3.000 30000.000 NOS
5. OUTER CARTON 2500.00 2.000 2502.000 NOS
6. CORRUGATED BOX R – 09 69.000 69.000 NOS

 MANUFACTURING SPECIFICATIONS:

Average fill of each Tube is 10 grams.

Weight variation limit allowed in each filled Tube is + 200 mg.

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

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

Add Fluocinolone Acetonide to the bulk batch at room temperature.

Colloid the cream till uniform particle size is achieved.

The temperature of primary area should not exceed 30˚C.

Yield:

Theoretical Yield is 30000 Tubes.

Expected Practical Yield is 30000 + 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 each unit cartons.

Pack such 12 tubes in one outer carton.

Seal the outer carton with cello tape.

Pack such 36 outer cartons in specified corrugated box  to give a pack size of 36 x 12 x 10g tubes.

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

MANUFACTURING PROCESS:

Melt 10 kg of Ceto Macrogol – 1000, 30 kg of Cetocetyl Alcohol, 15 kg of Liquid Paraffin Light, 48kg of White Petroleum Jelly in a Steam Heat Wax Melting Vessel by operating it as per its SOP at temperature 70˚C.

Heat 191.0kg 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 0.600 kg of Methyl Paraben Sodium in 2 kg of hot water and transfer it to the bulk batch.

Dissolve 0.300 kg of Propyl Paraben Sodium in 1 kg of hot water and transfer it to the bulk batch.

Dissolve 0.300 kg of E.D.T.A. in 3 kg of hot water and transfer it to the bulk batch.

Dissolve 0.600 kg of Sodium Metabisulphite in 3 kg of hot water and transfer it to the bulk batch.

Take 30 kg of hot water and suspend 3.150 0kg of Clotrimazole and pass it through Colloidal Mill to achieve the slurry of uniform particle size by operating it as per its SOP and transfer it to the bulk batch.

Take 20 kg of hot water and suspend 1.830 kg of Ciprofloxacin Hydrochloride 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 Mixer vessel.

Triturate 78.000 g of Fluocinolone Acetonide in mortar-pestle with 2kg of Liquid Paraffin light by the gradually addition of the same. Add this to the bulk batch.

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 the storage tank. 

IN-PROCESS CONTROLS: 

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

Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.

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 Pharmacist and QC/QA Manager.

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

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.

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

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

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.

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

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.

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

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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