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Magazines & Newsletters / ASTM Standardization News


September/October 2008

disinfectantClean Room Disinfectants

A new ASTM International standard responds to a recent emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments. The new standard, E2614, Guide for Evaluation of Clean room Disinfectants, was developed by Subcommittee E35.15 on Antimicrobial Agents, part of ASTM International Committee E35 on Pesticides and Alternative Control Agents.

“Until recently, there has been very little regulatory guidance related to the selection, evaluation and qualification of chemical disinfectants,” said Carol Bartnett, E35 member and a senior scientist at STERIS Corp., in 2007 about the development of the standard (for January 2007 SN article, click here). “However, recent published regulatory guidelines specifically state the need to demonstrate conclusively that the disinfectants used in the manufacturing area are effective under the conditions in which they are used.”

As an example of recent disinfectant-related regulation, Bartnett cites the U.S. Food and Drug Administration’s Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice, which was issued in September 2004 and clearly recommends evaluating the suitability, efficacy and limitations of disinfecting agents. USP chapter 1072, Disinfectants and Antiseptics, which became official on Aug. 1, 2006, provides guidance for selecting suitable disinfectants and challenge testing to demonstrate efficacy within controlled environments. 

The new standard identifies key criteria that industry personnel should consider when selecting an appropriate disinfectant and discusses test methods suitable for determining the efficacy of selected products in the laboratory and in situ. Pharmaceutical and biotechnology companies with aseptic processing areas (clean rooms), compounding pharmacies and related industries using disinfectants for control of microbial bioburden will find E2614 useful.


Technical Information: Carol Bartnett, STERIS Corp., St. Louis, Mo.

Phone: 314-290-4611

ASTM Staff: Jennifer Rodgers

Phone: 610-832-9694