SOP for Monitoring of Aseptic Area by Passive Air Sampling

OBJECTIVE

The objective of this SOP is to lay down a procedure for monitoring of the aseptic area by passive air sampling (Settle plate method).

RESPONSIBILITY

The Quality Assurance Personnel shall be responsible for Sampling.

The Microbiologist shall be responsible for sampling and interpretation of results.

Executive - Quality Control shall be responsible for checking and approving the results.

ACCOUNTABILITY

Head - Quality Control

PROCEDURE

• Prepare the settle plates as per SOP
• Carry the required number of plates to the concerned areas by putting them into an air-tight SS container and transferring them as per SOP.
• Enter in the respective areas by following the proper entry (gowning) procedure.
• Before entering into the area spray the outer portion of the container followed by moping with a lint-free cloth with 70% IPA solution.
• Open the container in the respective areas and put, the date & time at the base of the plates.

• Expose the sterile petri-plates to the pre-determined areas.
• The exposure time in a sterile (aseptic) area is four hours.
• After completion of exposure time cover those plates put them into the carrier container and bring those exposed plates to the microbiology laboratory incubate them, in an inverted position, in the incubator at 20-25°C for 72 hrs followed by 30-35°C for 48 hrs.
• After completion of the incubation period observe the plates and note down the observations in the format mentioned in the monitoring plan.
• Frequency, limits, and locations are mentioned in the monitoring plan.

ANNEXURE

Nil

REVISION HISTORY

Nil

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