TABLE XI

Typical Microorganisms Isolated from Pre-Sterilization Bioburden Samples and the Manufacturing Environment

Test OrganismComments
Staphylococcus hominisIdentified in pre-sterilization bioburden and manufacturing environment
Staphylococcus cohniiIdentified in manufacturing environment
Staphylococcus lugdunensisIdentified in pre-sterilization bioburden
Micrococcus luteusIdentified in pre-sterilization bioburden
Kocuria kristinaeIdentified in pre-sterilization bioburden and manufacturing environment
Pseudomonas aurantiacaIdentified in pre-sterilization bioburden
Sphingomonas sp.Identified in pre-sterilization bioburden and manufacturing environment
Vibrio tubiashiiIdentified in pre-sterilization bioburden
Ralstonia insidiosaIdentified in pre-sterilization bioburden and manufacturing environment
Alcaligenes faecalisIdentified in pre-sterilization bioburden
Saccharomyces cerevisiaeIdentified in pre-sterilization bioburden
Bacillus pumilusIdentified in pre-sterilization bioburden and manufacturing environment