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Friday, May 7, 2010

MANUFACTURING PROCEDURE Clarathromycin Tablet 250 mg

1. Mix Clarithromycin, Lactose and Sodium lauryl Sulphate after passing it through 20 SS mesh for 30-45 minutes in horizontal mixer.

2. Dissolve PVP K30 in IPA.

3. Add this to the content of the mixer and Knead for 15-20 minutes.

4. Sieve the wet mass through wet granulator having mesh size of 5mm.

5. Semidry it in F. Bed dryer without heat incrementally. Each increment should be 15-20 Kg. Crush these semidried granules through oscillating using 16 # mesh. Then dry completely at 50Âșc for 5 -10 minutes.

6. Load this granular powder in horizontal mixer and add Avicel PH 102 after sieving SS mesh # 40 mix for 30 minutes then add Mg. Stearate, Primojel & Aerosil after screening through mesh # 40 and mix for 10 minutes.

7. Shift the material in containers containing Poly bags with proper identification, to the in process quarantine.

8. When the batch is passed for compression, shift it to compression section when required.

9. After the compression is completed intimation for release for coating is given to QA. After getting sampled shift the Tablets to the in process quarantine.

10. When passed for coating, shift it to coating section when required.

11. After the batch is coated give intimation to QA for release of batch for blistering and shift the coated tablets in airtight containers to in process quarantine.

12. After the batch is approved for blistering, shift the batch to blistering section if required.

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