Keep in mind that non-sterile facilities are just what they say they
are --NON-STERILE-- and most environmental monitoring is only a "snapshot"
of the microbial bioburden at the time of sampling. Here are some
references for you and the rest of the group:
PhRMA Environmental Monitoring Working Group. "Microbiological Monitoring
of Environmental Conditions for Nonsterile Pharmaceutical Manufacturing",
Pharmaceutical Technology, March, pp. 58, 60, 64, 66, 68, 70, 72,74, 1997.
Dell, L.A. "Aspects of Microbiological Monitoring for Nonsterile and Sterile
Manufacturing Environments", Pharmaceutical Technology, August, pp. 47-51,
Adbou, M.A.F. "Determination of Airborne Microorganisms in a Pharmaceutical
Plant Using Standard, Elective and Selective Culture Media", Pharmaceutical
Technology, November, pp. 93-98, 100, 1980.
CTFA. "Microbiological Evaluation of the Plant Environment", CTFA
Microbiology Guidelines, 1-12, 1993.
Favero, M.S. et al. "Environmental Monitoring Procedures", In: Compendium
of Methods for the Microbiological Examination of Foods", Speck, M.L. (ed),
2nd ed., pp. 47-61, 1984.
Whyte, W. "In Support of Settling Plates", J. Parenteral Sci. & Technol.,
Vol. 50, No. 4, pp. 201-204, 1996.
Wilson, J.D. "Setting Alert/Action Limits for Environmental Monitoring
Programs", J. Parenteral Sci. & Technol., Vol. 51, No. 4, pp. 161-162.
PDA Environmental Task Force. "Fundamentals of a Microbiological
Environmental Monitoring Program", Vol. 44, Technical Report 13, Suppl.,
Robert R. Friedel
Quality Assurance Manager
Laboratory Research & Analysis Groups
Perritt Laboratories, Inc.
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----- Original Message -----
From: Shih, Katherine <[log in to unmask]>
To: <[log in to unmask]>
Sent: Thursday, October 07, 1999 9:23 PM
Subject: [PMFLIST] Environmental Monitoring for Non-sterile Manufacturing
> I am reviewing our EM practices for non-sterile manufacturing areas. Do
> know any guidelines or references that that I can use? Thank you.
> Katherine Shih
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