New Regulations Prompt Need for Disinfectant Standard
Responding to a new emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments, ASTM International Committee E35 on Pesticides and Alternative Control Agents has begun to develop a proposed new standard, WK12880, Guide for Evaluation of Clean Room Disinfectants. WK12880 is under the jurisdiction of Subcommittee E35.15 on Antimicrobial Agents.
“Until recently, there has been very little regulatory guidance related to the selection, evaluation and qualification of chemical disinfectants,” says Carol Bartnett, senior scientist, STERIS Corporation. “However, recent published regulatory guidelines and standards 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 ProcessingCurrent 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 the selection of suitable disinfectants and challenge testing to demonstrate efficacy within controlled environments.
WK12880 will identify key criteria that industry personnel should consider when selecting an appropriate disinfectant and will discuss laboratory test methods suitable for determining the efficacy of selected products in the laboratory and in situ. The proposed guide will be applicable to regulated industries that use disinfectants to control microbial bioburden in critical manufacturing environments. These industries include pharmaceutical and biotechnology companies with aseptic processing areas (clean rooms), compounding pharmacies and related industries using disinfectants for control of microbial bioburden.
Bartnett notes that WK12880 is currently in first draft status and that feedback, comments and suggestions are essential to assure its development as a useful and applicable standard. “Subcommittee E35.15 welcomes active participation in the development of this and future standards in the area of antimicrobial and antiviral agents,” says Bartnett. The subcommittee would particularly like the participation of those with experience in quality assurance, microbiology, pharmaceutical manufacturing and related fields. //
Technical Information: Carol Bartnett, STERIS Corporation, St. Louis, Mo.
ASTM Staff: Daniel Smith
West Conshohocken, Pa.