Determination of Components Bioburden before Sterilization

SUBJECT Determination of Components Bioburden before Sterilization 

The purpose is to evaluate the bioburden, spore bioburden, and endotoxin present on rubber stoppers and unprocessed glass vials. The similarity of contents and equipment may be coincidental as the similar and common inventory are used by the generic manufacturers. 

It is the responsibility of concerned microbiologists to follow the procedure. The quality control (QC) manager is responsible for SOP compliance 

Sterile filtration units, 47-mm size, with filtration manifold 

Depyrogenated soda-lime (flint) 10 x 75 test tubes Depyrogenated borosilicate 13 x 100 mm test tubes Test tube rack 

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Section Val. 1900 includes four aseptic processes associated with monitoring and qualification programs covering determination of components bioburden before sterilization sterility test failure investigation, bacterial endotoxin determination in WFI, in-process finished product, and monitoring the bioburden, spore bioburden, and endotoxin present on stoppers and unprocessed vials. 

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