Monitoring of aseptic area by passive air sampling (by settle plate method ).

1.0              OBJECTIVE:

The objective of this SOP is:

1.1               To lay down a procedure for monitoring of aseptic area by passive air sampling  ((Settle plate method ).

2.0              RESPONSIBILITY:

2.1               The Quality Assurance Personnel shall be :

2.1.1          Responsible for Sampling.

2.2               The Microbiologist shall be :

2.2.1          Responsible for sampling and interpretation of results.  

2.3               Executive - Quality Control shall be :

2.3.1          Responsible for checking and approving the results.

3.0              ACCOUNTABILITY:

Head - Quality Control

4.0              PROCEDURE:

           

4.1               Prepare the settle plates as per SOP

4.2               Carry required number of plates to the concerned areas by putting into a air tight S-S container and transfer as per SOP.

4.3               Enter in the respective areas by following the proper entry (gowning) procedure.

4.4               Before entering into the area spray the outer portion of the container followed by moping with a lint free cloth with 70% IPA solution.

4.5               Open the container in the respective areas and put , date & time at the base of plates .

4.6               Expose the sterile petri-plates at the pre determined areas.

4.7               The exposure time in sterile (aseptic) area is four hours.

4.8               After completion of exposure time cover those plates and put them into the carrier container and  bring those exposed plates to the microbiology laboratory incubate them, in inverted position, in the incubator at 20-25°C for 72 hrs followed by 30-35°C for 48 hrs .

4.9               After completion of the incubation period observe the plates and note down the observations in the format mentioned in monitoring plan.

4.10            Frequency, limits and locations are mentioned in the monitoring plan.