RT Journal Article
SR Electronic
T1 The Incubation Period in Sterility Testing
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 254
OP 257
VO 47
IS 5
A1 Bathgate, Helen
A1 Lazzari, David
A1 Cameron, Helen
A1 Mckay, David
YR 1993
UL http://journal.pda.org/content/47/5/254.abstract
AB Sterility test results gathered over a ten year period have been analysed to determine the effects of the incubation period. Overall there was no difference between the membrane filtration test and direct inoculation in the time required for visible growth of contaminants. Growth occurred earlier if products had no preservative or antimicrobial substances. However use of the membrane filtration method did not significantly enhance the efficiency of detection at seven days incubation. Regardless of the nature of the product or the method of test an unacceptable proportion of contaminants would be missed by limiting incubation to seven days.