PT - JOURNAL ARTICLE AU - Slater, G. J. AU - Johnston, D. TI - Microbiological Environmental Monitoring during Sterile Product Manufacture: Adaptation of Methods for a Research Facility DP - 1988 Jul 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 111--113 VI - 42 IP - 4 4099 - http://journal.pda.org/content/42/4/111.short 4100 - http://journal.pda.org/content/42/4/111.full SO - PDA J Pharm Sci Technol1988 Jul 01; 42 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.