MFR OF OFLOXACIN  SUSPENSION

PURPOSE: This Standard Operating Procedure 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 is 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: Liquid Section

COMPOSITION:

Each 5 ml contains:

Ofloxacin                                      U.S.P.          50 mg

EQUIPMENTS TO BE USED: 

EQUIPMENTS TO BE USED: 

RAW MATERIAL:-

 PACKING MATERIAL:- 

MANUFACTURING SPECIFICATION:

1. Average fill of each Bottle is 30 ml.
2. Volume variation limit allowed in each filled Bottle is 30 ml to 32 ml.
3. Make up the final volume of the suspension accurately.
4. Transfer the suspension from charging tank L-10 to storage tank L-14 after complete charging of batch.
5. Mix the batch, Fill the bottles and also perform the primary packing of bottles at temperature not more than 25⁰ C and Relative Humidity not more than 40.

Yield:

• Theoretical Yield is 50,000 Bottles.
• Expected Practical Yield is 50,000 + 2% Bottles.

Packing Details:

1. Wash the bottles on Linear Bottle Washing Machine and operate it as per its SOP.
2. Transfer the suspension from a storage tank to Digipack
3. Bottle Filling and Sealing Machine for filling and then Sealing of the bottles as per its SOP.
4. Fill 30 ml suspension in 32 ml amber round bottle and use 25 mm PP Cap to seal the bottle mouth.
5. Inspect the each filled and sealed bottle for proper sealing and presence of the foreign particles, if any.
6. Label every inspected bottle by using the Automatic Bottle Labelling Machine.
7. Pack each filled and sealed bottle in unit carton individually.
8. Make a group of 12 bottles packed in unit cartons.
9. Wrap this bundle in the thermoplastic film and shrink pack it by operating Shrink Packing Machine  as per its SOP 
10. Pack such 12 shrinked packets in the Corrugated box. Thus each corrugated box contains 12 x 12 x 30 ml filled and sealed bottles.

MANUFACTURING PROCESS:

1. Soak 7.5 kgs of Xanthan Gum in 90 Ltrs of purified water in Stainless Steel Containers and keep it for 6 hours.
2. Add 1200 kgs of Invert Sugar to the tank.

 Addition of Ingredients into the Charging Tank  while stirring continuously:      

1. Dissolve 1.5 kgs of Methyl Paraben Sodium and 0.375 kgs of Propyl Paraben Sodium in 15 Ltrs of purified water and add to the bulk batch.
2. Dissolve 1.5 kgs of Aspartum (P) in 10 Ltrs of hot purifed water and add to the bulk batch.
3. Now perform the following:
   • Heat 300 Ltrs of purified water in Stainless Steel Container.
   • Add 3.375 kgs of Citric Acid to it and stir to dissolve.
   • Add 15.75 kgs of Ofloxacin to it and stir to dissolve completely.
   • Add 9.0 kgs Calcium Gluconate and stir it to dissolve it.
   • Transfer this to the bulk batch.
4. Add 150.0 kg of Sorbitol Solution to the tank.
5. Add 3.0 kgs of Aerosil to the bulk batch.
6. Add previously soaked Xanthan Gum to the same charging tank.
7. Add 150 Ltrs of purified water to the bulk.
8. Colloid the batch through Colloidal Mill by operating it as per its SOP  and transfer it to the Charging Tank.
9. Add 3.75 Ltrs of Orange Flavour to the bulk.
10. Dissolve 0.375 kgs of Menthol in 2.25 LTRS of Spirit Chloroform and add to the bulk batch.
11. Make up the volume with purified water to 1500 Ltrs and Mix the whole batch for one hour.
12. Leave the Suspension to settle for overnight or for minimum 8 hours.
13. Again check the volume and make up with purified water to 1500 Ltrs and mix until homogeneous.
14. Check the pH of Solution to be in between 5.0 – 6.0.
15. Send the sample to Quality Control Department for bulk testing.
16. Transfer it to the 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 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. Final volume should be made as per Standard Operating Procedure using a correct dipstick in the  Manufacturing Chemist.
5. pH of the bulk should be checked and it should be within specified limits.
6. Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.
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

9. 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.
10. Suspensions should be filled under constant slow speed stirring to maintain uniformity of contents.
11. The labels and cartons should be checked thoroughly for proper batch coding.
12. Intimation should be sent to Quality Control Department for finished product sampling and testing.
13. 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.
14. It will ensure that filling or packaging equipment has been properly cleaned.
15. Filling or packaging of next product should not commence until the IPQA  has given the ‘Line Clearance’.

MFR OF CLOXACILLIN SODIUM ORAL SUSPENSION USP