SOP on Environmental Monitoring
(Surface Plate Method)
1.0 Purpose: This SOP provides a complete description of the method and schedules for taking samples for monitoring the surfaces in all production areas for non-viable and viable counts to ensure compliance with predetermined cleanliness levels.
2.0 Scope: This SOP applies for taking the required samples for the routine monitoring of production areas.
3.0 Responsibility:
3.1 Quality Control microbiologist is responsible for testing microbial count and reporting results.
3.2 Quality Assurance Manager is responsible to ensure that procedure is followed and to investigate if acceptable levels are exceeded.
4.0 Materials and Equipment:
Prepared agar plates
Incubator
Disinfectant for decontaminating surfaces of wrapped plates
Autoclave
Chart of sampling locations for each room
Colony counter
5.0 Procedure:
5.1 Place the prepared agar plates at sampling locations identified.
5.2 Remove the lid of plates and expose the plate for 120 minutes.
5.3 Replace the lid on the plates and then keep in an incubator at 350C ± 20C for 48 hours.
5.4 The counts are done on colony counter by counting the number of colonies.
6.0 Reporting: Fill in record sheets and indicate any deviations to the sampling schedule or procedure and report to Quality Assurance manager.