The influence of incubation conditions in sterility tests.

PDA J Pharm Sci Technol

Instituto Adolfo Lutz, Av. Dr. Arnaldo, 355 - São Paulo - SP, CEP 01246-902, Brasil.

Published: March 2004

Studies were conducted to evaluate the effects of media, incubation temperature and duration on the detection of bacteria and fungal growth using British, United States and Brazilian compendial sterility test methods. 5 to 50 CFU of nine different microorganisms (including both anaerobic and aerobic bacteria and molds) were used to contaminate test units containing various growth media (sobean-casein digest, thioglycollate, Sabourand and Causen broths). Test units were incubated at temperatures ranging from 12 to 42 degrees C for 1 to 28 days. Inoculations were conducted according to compendial procedures. Optimal detection conditions were obtained at 22 to 32 degrees C over 14 days using soybean casein digest and thioglycollate broths.

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