Disinfection Qualifications for Cleanroom Disinfectants

The following methods are used for Disinfection Qualifications for Clean-Room Disinfectants:

  • USP <1072>
  • ASTM E2614

Purpose of Test

An effective disinfection program is critical to assure the quality of the products produced in aseptic processing areas of a Good Manufacturing Practice (GMP) facility. The U.S. FDA requires that, “the suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured by their ability to ensure that potential contaminants are adequately removed from surfaces.” In order to qualify the disinfection practices and procedure used in these facilities, in vitro testing may be performed to simulate these practices following the methods and recommendations found in the USP 1072 and ASTM E2614 documents.

Summary of Test

In these studies, representative surfaces found in the cleanroom of the GMP facility are inoculated with specific test organisms (commonly Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Penicillium chrysogenum, Aspergillus brasiliensis, Bacillus subtilis) plus any routine contaminants found during the manufacturing process. The surfaces are disinfected using the disinfection practices commonly used at the facility, exposed, neutralized and assayed for survivors. Although the level of reduction deemed necessary for appropriate disinfection is determined by the GMP facility performing the qualification, the USP 1072 recommends that for bacterial spore-formers (i.e. Bacillus), a minimum 2 log10 reduction should be observed and for vegetative bacteria and fungi, a minimum 3 log10 reduction should be observed.