How Risky Are Pinholes in Gloves? A Rational Appeal for the Integrity of Gloves for Isolators

References

1. 1.↵
   USP 32, Vol. 1, General Information, Chapter 〈1208〉 Sterility Testing, Validation of Isolator Systems, pp 715–718. USP; U.S. Pharmacopeial Convention; Rockville, MD 20852 (USA); May 2009.

   OpenUrl
2. 2.↵
   Pharmaceutical Inspection Convention; PIC/S. Recommendation on Isolators Used for Aseptic Processing and Sterility Testing; PI 014-1, 24 June 2002.
3. 3.↵
   FDA. Guidance for industry. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. September 2004.
4. 4.↵
   Angela Gessler. Diplomarbeit: Mikrobiologische Relevanz einer physikalischen Dichtigkeitsprüfung. University of Applied Science, Albstadt-Sigmaringen (D). March 2003.