ENVIRONMENTAL MICROBIAL MONITORING OF PHARMACEUTICAL ASEPTIC MANUFACTURING AREA BY SETTLE PLATE METHOD

SOP for monitoring microbial load in aseptic area sterile plate count menthod

To asses the microbial load in aseptic area by means of plate count by settle plate method

UNIT OF RESPONSIBILITY:- QA Executive and trained QA Assiatants

IMPORTANT POINTS/NOTES/PRECAUTIONS:-

1 Ensure that plates are not exposed for longer period as they may get dessicated

2 The media used should be asigned a batch no

MATERIAL:-

1 Sterile Nutirent agar prepared as per sop for media preparation

2 Bateriological Incubator adjusted the temperature of 35-37 deg C

3 Autoclave

PROCEDURE:-

1 Prepare the nutrient agar media as per the media preparation SOP

2 Autoclave the media at 121 deg C ( 15 lbs ) for 20 minutes

3 After completion of autoclaving transfer the media to the microbioogy room

4 Prepare the plates by pouring the sterile molten cooled Nutrient agar medium aseptically taking care to avoid contamination from the person preparing them Cool the plates

5 The prepared plates are numbered and incubated for 24 hrs at 35 – 37 deg Cpror to sendig for exposure

6 Place the preincubated petri plates with its lid still covering the agar at predetermined positions f moinitoring

7 Remove the lid and rest it on the rim of the dish base whereby maximum exposure of
the agar surface is made

8 Leave the nutrient surface exposed for 2 hours

9 Keep one unexposed plate for negative control and one plate which is exposed in non sterile area for positive control

10 Incubate the plates an inverted position for minimum 3 days at 35 – 370C

11 Count and record the total number of colony forming units(cfu) observed on the surface of the agar after every 24 hours till completion of 72 hours of incubation

12 Maintain the records as per the attachment

ACTION PROCEDURE  limit for Area microbial count
If the number of organism recorded is higher than the agreed action limit, get the area / machine throughly cleaned as per the standard operating procedure for cleaning In case of mould counts get the area / machine cleaned with 70 % IPA and fumigate the area

Standard operating procedure SOP for microbiology and aseptic techniques

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