PT  - JOURNAL ARTICLE
AU  - Deborah J. Jones
AU  - Peter Topping
AU  - John Sharp
TI  - Environmental Microbial Challenges to an Aseptic Blow-Fill-Seal Process—A Practical Study
DP  - 1995 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 226--234
VI  - 49
IP  - 5
4099  - http://journal.pda.org/content/49/5/226.short
4100  - http://journal.pda.org/content/49/5/226.full
SO  - PDA J Pharm Sci Technol1995 Sep 01; 49
AB  - 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.