ASTM Int'l Issues Cleanroom Disinfectant Standard- ASTM E 2614

August 28, 2008 // Published as a news service by IHS

ASTM E 2614 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.

ASTM International released the standard to address emphasis by regulatory agencies that firms manufacturing drug products demonstrate the efficacy of disinfectants used in controlled environments, according to ASTM International.

The standard 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.

"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." A

As an example of recent disinfectant-related regulation, Bartnett cited 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 recommends evaluating the suitability, efficacy and limitations of disinfecting agents.

Another example of disinfectant-related regulation is United States Pharmacopeia chapter 1072 - Disinfectants and Antiseptics, which became official on Aug. 1, 2006. It provides guidance for the selection of suitable disinfectants and challenge testing to demonstrate efficacy within controlled environments.

Source: ASTM International.