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
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.