Samples for sterility testing should be representative
From parts of the batch, most at risk
- aseptic filling - at beginning and end of batch filling, and after interruptions
- heat sterilized - coolest part of the load
Sterility of the batch ensured through validation
- validated sterilization cycle
- media fill
Sterility test procedure as per pharmacopoeia, and validated for each product
Batch processing records, sterility testing records, environmental records should be reviewed
In this final part of the module, we are also going to look at the quality control.
Testing for sterility is a destructive test, and one cannot test every ampoule that comes from the batch. It is therefore necessary to ensure that samples for sterility testing are representing the batch, and where possible, the worst case scenario. Samples should be taken from parts of the batch that are most at risk. These are:
Aseptic filling - at beginning and end of batch filling, and after interruptions
Heat sterilized - coolest part of the load.
As sterility of the batch can not be ensured through testing, it has to be ensured through validation. This includes qualification of the equipment, supporting systems, process and sterilization cycle.
For aseptic processes, media fills have to be done at regular intervals.
The sterility test procedure should be as per pharmacopoeia, and validated for each product.
Batch processing records, sterility testing records, environmental records should be reviewed as part of the batch evaluation and release procedure.