Overall Conclusions

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Chapter: Pharmaceutical Microbiology : Sterility Testing: Pharmaceutical Products

The various techniques described in this chapter essentially make a sincere and benevolent attempt to accomplish to a reasonably large extent, the stringent control and continuous monitoring of a specific sterilization process.


OVERALL CONCLUSIONS

 

The various techniques described in this chapter essentially make a sincere and benevolent attempt to accomplish to a reasonably large extent, the stringent control and continuous monitoring of a specific sterilization process. However, it is pertinent to state here that the ‘sterility test’ on its own fails to provide any guarantee with respect to the specific sterility of a batch. Nevertheless, it categorically acounts for an ‘additional check’, besides a continued compliance and offer sufficient cognizable confidence pertaining to the degree of an aseptic process or a sterilization technique being adopted.

 

Interestingly, an absolute non-execution of a prescribed (as per the ‘Official Compendia’) sterility test of a particular batch, despite the equivocal major criticism and objection of its gross inability and limitations to detect other than the gross contamination, could tantamount to both moral consequences and important legal requirements.

 

US-FDA promulgates and strongly advocates the adherence of USP-prescribed requirements for the ‘sterility test’ for parenterals as the most authentic, reliable, and trustworthy ‘guide for testing the official sterile products’.

 

On a broader perspective, it may be observed that the ‘sterility test’ is not exclusively intended as a thoroughly evaluative test for a product duly subjected to a known sterilization method of unknown effectiveness. Nevertheless, it is solely meant primarily as an intensive ‘check test’ on the ensuing probability that :

 

·        a previously validated sterilization process has been repeated duly, and

 

·        to provide adequate assurance vis-a-vis its continued effictiveness legitimately.

 

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