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Tuesday, August 11, 2009

SOP Standard Operating Procedure monitoring microbial quality of compressed pharmaceuticals manufacturing

Standard operating procedure SOP for monitoring microbial quality of compressed air used in pharmaceuticals manufacturing membrane filtration method.

1 Sterile Soybean casein digest medium

2 Sterile Soybean casein digest agar

3 Sterile 500 ml 01% peptone water


1 Pass about 1000 liters of compressed air from a predetermined points to the 500 ml of 01% peptone
2 Aseptically transfer the 250 ml of peptone water to each of two membrane filter funnel and immediately pass the peptone through the membrane of 045u with the aid of vacuum

3 Keep the membrane filter covered with liquid throughout the filtration for maximum efficiency of filter

4 Aseptically remove both the membrane from the filter holder and transfer one of the membrane filter
in sterile petri plate, intended for the enumeration of viable bacteria and other membrane filter to the
soybean casein digest medium for detection of pathogens

5 Pour 20 ml of sterile molten cooled soybean casein digest agar on plate Cool the plate

6 Carry out positive and negative control along with the test sample

7 Then incubates the plates and tubes at 35 - 370c for 72 hours for enumeration of viable bacteria

and 24 - 48 hours for detection of pathogens respectively

8 At the end of the incubation period count the colony forming units ( cfu ) on the plate and maintain
the records

9 If the tubes shows growth in terms of turbidity, carry out identification test for specified pathogens

Standard operating procedures SOP for microbiology and aseptic techniques for manufacturing of sterile dosage forms injections , pharmaceuticals

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