PT  - JOURNAL ARTICLE
AU  - Polarine, James N
AU  - Bartnett, Carol
AU  - Shields, David J
TI  - Disinfectant Effectiveness Testing Challenges
AID  - 10.5731/pdajpst.2016.006700
DP  - 2016 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2016.006700
4099  - http://journal.pda.org/content/early/2016/10/21/pdajpst.2016.006700.short
4100  - http://journal.pda.org/content/early/2016/10/21/pdajpst.2016.006700.full
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.