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Monday, August 10, 2009

SOP BIOBURDEN TESTING MEMBRANE FILTERATION METHOD


Standard operating procedure SOP for Bioburden Testing Membrane filtration method .

OBJECTIVE :- To Check the load of microorganisms in the Pharmaceuticals manufactured


UNIT OF RESPONSIBILITY : QA Executive and trained QA Assistants



IMPORTANT POINTS/NOTES/ PRECAUTIONS:

1 Ensure that proper conditions are maintained during the testing to avoid contmination to the from the analyst
2 Ensure that all the material used for testing are sterilised prior to the testing

PROCEDURE:

1 All operations are carried out in a laminar flow cabinet using aseptic technique and Aseptic technique guidelines throughout

2 Take approxemately 1 gm from not less than 10 tubes in not less than 100 ml of prefiltered isopropyl
myristate (IPM)

3 Warm the solvent containing to not more than 44 deg C, swirl the flask to dissolve the ointment in 4 Filtered the dissolved ointment promptly Following dissolution aseptically transfer the mixture membrane filter holder and filter it with the aid of vacuum

5 Keep the membrane covered with liquid throughout the filteration for higher efficiency of filter

6 Following filteration wash the membrane with 300 ml of sterile 01 % of peptone water

7 Aseptically remove the membrane from the filter holder transfer into an empty sterile plate Pour 20 ml of

sterile molten soybean casien digest agar on it The temperature of the molten agar should not 45 deg C

8 Let the medium solidify, then incubate the plate at 35- 37 deg C for 72 hrs in an inverted position

9 Carry out the positive and negative control along with the test

10 Count the number of colony forming units (cfu) on the plate

11 Maintain the records for boburden in the attachment 1

OTHER RELEVANT DETAILS:

1 Limits : 100 cfu/gm

PERSONNEL TO BE REPORTED IN CASE OF NON COMPLIANCE :- QA Executives, Production manager

FREQUENCY OF OPERATION : Batchwise



NO OF ATTACHMENT :- 


RETENTION PERIOD OF RECORDS:- 5 Years

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