Power Failure in aseptic activity is most dangerous due to HIGH RISK to the product being prepare on line for patient safety. A high risk to product quality due to failure in sterility and non-viable counts.
There shall be always power back program for such activity and should be on Auto mode.
Do You Agree?
Any disruption in power supply, however momentary, that could affect product quality is a manufacturing deviation and must be included in batch records (211.100, 211.192). (Page 43)
ReplyDelete3. Frequency
The design of the interior and content of an isolator should provide for its frequent decontamination. When an isolator is used for multiple days between decontamination cycles, the frequency adopted should be justified. This frequency, established during validation studies, should be reevaluated and increased if production data indicate deterioration of the microbiological quality of the isolator environment. A breach of isolator integrity should normally lead to a decontamination cycle. Integrity can be affected by power failures, valve failure, inadequate overpressure, holes in gloves and seams, or other leaks. Breaches of integrity should be investigated. If it is determined that the environment may have been compromised, any product potentially impacted by the breach should be rejected. (Page 47)
In both case it will be deviation to power faliure; expectations are uninterupt power supply and if fails need investigation 211.100(b) for safety / supply.