Biosafety professionals have ever-expanding roles at their institutions. In this Beyond
Traditional Biosafety column, we focus on topics that may fall outside the scope of the
traditional biosafety role, but where the expertise of the biosafety professional may be
called upon to provide a valuable contribution to his or her institution. Please e-mail
any comments, suggestions, or insights to Bryan Connors at bconnors@eheinc.com.
References
1.
ISO Standard 14644–2. Cleanrooms and associated controlled environments—part 2: Specifications for
testing and monitoring to prove continued compliance with ISO 14644–1. Geneva: International Organization for
Standardization; 2000.
2.
Pharmaceutical Inspection Co-operation
Scheme (PIC/S). Guide to good manufacturing practice for
medicinal products. Annexes PE 009–6. Geneva: PIC/S; 5 April 2007.
3.
United States Department of Health and
Human Services (HHS), Centers for Disease Control and Prevention (CDC). Multistate outbreak of fungal meningitis and other infections; 23 October 2013 [cited 2014]. Available from: www.cdc.gov/hai/outbreaks/meningitis.html.
4.
United States Department of Health and Human
Services (HHS), United States Food and Drug Administration (FDA). Guidance for industry-sterile drug products produced by aseptic
processing—current good manufacturing practice. Baltimore,
MD: FDA; 2004.
5.
United States Pharmacopoeia, The
(USP). Chapter <797> “Pharmaceutical Compounding—Sterile
Preparations,”, 2012.
6.
United States Pharmacopoeia, The
(USP). Chapter <1116> “Microbiological Evaluation of Clean Rooms
and Other Controlled Environments,”, 2013.
