RT Journal Article
SR Electronic
T1 Microbiological Environmental Monitoring during Sterile Product Manufacture: Adaptation of Methods for a Research Facility
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 111
OP 113
VO 42
IS 4
A1 G. J. Slater
A1 D. Johnston
YR 1988
UL http://journal.pda.org/content/42/4/111.abstract
AB The environmental monitoring procedures applied during sterile product manufacture were optimized by use of multiple settle plates, larger diameter settle plates (14 cm), and extended exposure times in order to detect I cfu/m3 air. Due to the small batch size and short working time within the Class I area the exposure time could not be extended sufficiently to represent I cfu/m3 by 2 or more colonies per plate. The maximum exposure time that could be employed was 4 hours and, therefore, I cfu/m3 was represented by a total of 4 colonies on 4 × 14-cm settle plates.