Procedure for Air Sampling (Environmental Monitoring) in Sterile Pharmaceutical Manufacturing Area

Procedure for air sampling in pharmaceuticals

1 Prepare SCDA medium and aseptically pour approximately 15-20 ml of sterile molten cooled (40°C) SCDA agar into sterile 90 mm Petri plates
2 Allow solidifying the plates at room temp, after solidification label all the plates with the name of media, preparation batch No. and date of preparation.
3 Invert and incubate the plates at 30 to 35°C for 24-48 hrs. After incubation check the plates for any contamination, if there is contamination discard the plates.

4 After pre-incubation, label all the plates with the date of sampling, location and shift with the help of marker pen and wrap with aluminum foil and then place in a clean stainless steel container.
5 Transfer the container and Air sampler which is sanitized and wrapped in aluminum foil, to the sterile area through pass box and personnel must be entered through airlocks by proper entry and gowning procedure for the sterile area.
6 Place the pre-incubated SCDA plates in air sampler holder and operate the air sampler for time to sample 1000 ltrs of air.
7 After completion of Air sampling, remove the plates from Air sampler, close the lid immediately and place aside.
8 Immediately clean the Air sampler with 70% sterile IPA solution and carry out the air sampling for other specified locations.
9 After air sampling collect all the plates in clean SS container and send to microbiology laboratory through pass box. Follow the exit procedure to come out from sterile area.
10 Prepare positive control by streaking Bacillus subtilis and negative control as it is without streaking.
11 Invert all the plates and incubate at 20 to 25°C for 72 hrs and then 30 to 35°C for 48 hrs.
12 After incubation, count the number of colony forming units and with the help of colony counter and express the result cfu/m3.
13 Record the result as per the following formula-
X = Pr X 1000/V
Where
X = cfu/m3
r = colony forming units counted on 90 mm plates
Pr = Probable count obtained by positive hole correction from the table against r value
V = Volume of the air sample

Precautions

1 Maintain aseptic condition during air sampling.
2 Sanitize Air sampler with 70% IPA solution for each location sampling.
3 The result must be expressed as per the given formula.
4 All pre-incubated plates should be rejected if a single plate shows evidence of microbial contamination.

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