50.4.7 Sterilization50.4.7.1 Introducu.on. Sterilization and aseptic operationtaken together (as they must be) have a much greater influence on fermenter design and operation than does any otherrequirement.In theory (1) sterilization destroys or removes all for-eign organisms in all process equipment (including piping,seals, etc.) that might come into contact with the processfluid, and (2) aseptic operation insures that no contaminat-ing organisms enter the fermenter after sterilization. Theseideals are not attainable in practice because (among otherreasons) (1) there is a finite probability that a very low con-centration of contaminating organisms will not be capturedin a sample used to test for contamination, and (2) there isa finite probability of false positives due to sample contam-ination and so forth. It also is important to note that thereis a continuing debate concerning the definitions of pureculture and sterility (6,51).
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