TY - JOUR T1 - Environmental Microbial Challenges to an Aseptic Blow-Fill-Seal Process—A Practical Study JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 226 LP - 234 VL - 49 IS - 5 AU - Deborah J. Jones AU - Peter Topping AU - John Sharp Y1 - 1995/09/01 UR - http://journal.pda.org/content/49/5/226.abstract N2 - A Blow-Fill-Seal machine, set to aseptically fill sterile liquid TSB medium into 20 ml plastic containers, was subjected to a series of environmental microbial challenges in order to evaluate the effects of the room environment, and of the actions of persons in the room, on the sterility of the product. Despite a series of relatively severe stresses to the system, none of the units filled (approximately 44,000) were found, following incubation, to display growth. ER -