(For alert limit)
- If the colony forming units exceed the alert limit
a) Increase the frequency of cleaning from once to twice a shift.
b) Ensure that the disinfectants are used as per schedule mentioned in respective SOP
and Cleaning of the processing area is carried out as per respective SOP .
(For action limit)
- If the colony forming units exceed the action limit, investigate / check the following whether
- Entry / Gowning procedure is followed.
- Cleaning is done as per SOP in processing and filling area.
- Disinfectant schedule is followed as per respective SOP
- Prolonged Maintenance job performed if any.
- Personnel traffic in the area is increased.
- Major Power shut down has occurred.
- Positive pressure in the area is disturbed.
- Operator with history of adverse fingerprint reports worked in the area.
- Time of plate exposure.
- Any other incidence, which can increase the bioburden of the area, took place.
- Inform to QC dept. through QA dept. in writing the outcome of above investigation with Products / Batches manufactured and filled during the period.
- During the investigation period, increase the frequency of cleaning to twice a shift.
- Request QC dept. to identify the organism and suggest suitable disinfectant for the organism identified.
- Proceed as per the suggestions given by QC dept.