RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 226
OP 234
VO 49
IS 5
A1 Deborah J. Jones
A1 Peter Topping
A1 John Sharp
YR 1995
UL http://journal.pda.org/content/49/5/226.abstract
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.