RT Journal Article
SR Electronic
T1 The Influence of Incubation Conditions in Sterility Tests
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 399
OP 403
VO 57
IS 6
A1 Bugno, Adriana
A1 Pinto, Terezinha de Jesus Andreoli
YR 2003
UL http://journal.pda.org/content/57/6/399.abstract
AB 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 °C for 1 to 28 days. Inoculations were conducted according to compendial procedures. Optimal detection conditions were obtained at 22 to 32 °C over 14 days using soybean casein digest and thioglycollate broths.