Article CommentaryCommentary
Disinfectant Effectiveness Testing Challenges
Carol Bartnett, James N. Polarine and David J. Shields
PDA Journal of Pharmaceutical Science and Technology January 2017, 71 (1) 59-65; DOI: https://doi.org/10.5731/pdajpst.2016.006700
Carol Bartnett
1STERIS, 7405 Page Avenue, St. Louis, MO 63133 and
James N. Polarine Jr.
1STERIS, 7405 Page Avenue, St. Louis, MO 63133 and
David J. Shields
2Biotest Laboratories, Inc. a Subsidiary of STERIS, Brooklyn Park, MN

References
- 1.↵GMP Trends Newsletter, Issue #931, November 1, 2015; GMP Trends, Inc.: Boulder, CO.
- 2.↵GMP Trends Newsletter, Issue #931, November 1, 2015; GMP Trends, Inc.: Boulder, CO.
- 3.↵GMP Trends Newsletter, Issue #923, July, 1 2015. Published by GMP Trends, Inc. Boulder, CO.
- 4.↵FDA Inspections Compliance, Enforcement and Criminal Investigations. Warning Letter, May 24, 2007. Available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076398.htm
- 5.General Information Chapter <1072> Disinfectants and Antiseptics. In United States Pharmacopoeia USP 38–NF 33; United States Pharmacopeial Convention/National Formulary: Rockville, MD, 2015.
- 6.European Committee for Standardization EN-13697:2015. Chemical Disinfectants and antiseptics—Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas—Test method and requirements without mechanical action (phase 2, step 2). Available from British Standards Institute (BSI), 389 Chiswick High Rd., London W4AL, U.K.
- 7.PDA Technical Report No. 70. Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities. Parenteral Drug Association, Inc.: Bethesda, MD, 2015.
- 8.↵General Information Chapter <1227> Validation of Microbial Recovery from Pharmacopeial Articles. In United States Pharmacopoeia USP 38–NF 33; United States Pharmacopeial Convention/National Formulary: Rockville, MD, 2015.
- 9.↵
- Rutala W. A.,
- Weber D. J.
- 10.↵
- 11.↵STERISCorporation. Unpublished data, 2016.
- 12.↵
- Hunsinger B.,
- Abele A.,
- Bohm R.
- 13.↵
- Rohm-Rodowald E.,
- Chojecka A.,
- Jakimiak B.,
- Wiercinska O.,
- Ziemba B.,
- Kanclerski K.
- 14.↵FDA Form 483, May 2–25, 2011. Available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm275843.pdf.
- 15.↵
- Brown R. W. B.,
- Gilbert P.
- 16.↵
- Sutton S. V. W.,
- Proud D. W.,
- Rachui S.,
- Brannan D. K.
- 17.↵
- Salaman-Byron A.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 1
January/February 2017
Disinfectant Effectiveness Testing Challenges
Carol Bartnett, James N. Polarine, David J. Shields
PDA Journal of Pharmaceutical Science and Technology Jan 2017, 71 (1) 59-65; DOI: 10.5731/pdajpst.2016.006700
Jump to section
Related Articles
- No related articles found.