RT Journal Article
SR Electronic
T1 Disinfectant Effectiveness Testing Challenges
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2016.006700
DO 10.5731/pdajpst.2016.006700
A1 Polarine, James N
A1 Bartnett, Carol
A1 Shields, David J
YR 2016
UL http://journal.pda.org/content/early/2016/10/21/pdajpst.2016.006700.abstract
AB Disinfectants and sporicides are critical for microbial contamination control within the pharmaceutical, biotechnology, and medical device industries. GMP manufacturing facilities are expected to demonstrate that the biocides used in controlled environments are efficacious against the facility's environmental isolates on representative surfaces using site-specific preparation methods as described in SOPs. We present common issues highlighted by regulatory inspectors pertaining to disinfectant and sporicide qualification and potential difficulties when performing in vitro efficacy tests.