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Friday, May 7, 2010

MANUFACTURING PROCEDURE Levofloxacin Tablet 500mg

1- Mix Levofloxacin & Sodium Lauryl Sulphate after passing through 40ss mesh for 30-45 minutes in a horizontal mixer.

2- Heat the de-ionized water in a steam jacketed kettle up to boiling (Water having quantity 20%-27% of the total batch).

3- Add PVP K30 in boiling water with stirring.

4- When PVP is dissolved in water, filter this solution.

5- Add this to the content of the mixer and mix for 15-20 minutes.

6- Sieve through wet granulator having mesh size 5mm.

7- Semidry using Fluidized bed dryer at temperature between 50-60Co for 5-15 minutes incrementally. Each increment having 15-25Kg and crush it using 16ss mesh in oscillating granulator.

8- Then fully dry it in the same way as for step (7).

9- Load this granular powder in a horizontal mixer and add Avicel 102 after sieving through SS mesh 40 and mix for 25-35 minutes.

10- Add Mg.Stearate, Primojel and Aerosil after sieving through mesh # 40 and mix for 10-15 minutes.

11- Intimate QA to collect sample for QC Analysis.

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

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

14- 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.

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

16- 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.

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

18- Intimate to QA to collect sample for QC Analysis.

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