Training of Personnel:
- All the personnel working in the aseptic processing are should be trained for personal hygiene.
- The operator or chemist should be trained in gowning procedure for entering the area.
- The trained personnel should be evaluated in the trained SOP and he / she should get 100% in the evaluation.
- If person failed to get 100% in the evaluation he / she should be re trained and re evaluated.
- Once the person is evaluated he / she should demonstrate the gowning procedure before microbiologist.
- If the person found to be deviated from the SOP he / she should be retrained.
Qualification of Personnel:
- Once the person qualified for gowning procedure he / she should to qualified for bio burden monitoring by collecting the swabs in the aseptic area
- The person should be wear the gown and should enter the aseptic processing area.
- The person should be qualified for three times in three consecutive days.
- The microbiologist should submit the result to QA for review.
- If the results of the swabs are found with in the acceptance criteria the person is considered as qualified.
Validation of Personnel:
- The person qualified during the microbiology monitoring is not allowed enter in to the aseptic area till the person is validated in the media fill validation during the aseptic process simulation.
- The person qualified in the regular monitoring is allowed to participate in the media fill validation.
- The personnel involved in the media fill validation are checked for bio burden by swab method.
- The results of the swab test should be submitted to QA.
- The personnel validated in the media fill validation are allowed to work in the aseptic processing area.
- The personnel failed in the media fill should be retrained, requalified and re validated then only the personnel are allowed to work in aseptic processing area.
- QA should prepare a list of personnel validated to enter the aseptic processing area and display it at the septic processing area entry and QC microbiology with details of date of validation and date of re validation.
Incase of repeated failures:
- Microbiologist should monitor the bio burden of the validated personnel regularly as per the schedule.
- If a person found with failure for one time in the regular monitoring, he /she should under go re qualification for 3 time in 3 consecutive days.
- If the person is qualified in the re qualification he / she should not be allowed to work in the area till the person participate in the media fill and validated.
- If a person found be failure regularly in the routine bio burden monitoring
- he / she should not be allowed to work in the aseptic area.
- The person should be retrained, requalified and re validated.