ASTM E2614-15 Standard Guide for Evaluation of Cleanroom Disinfectants

Developed by the American Society for Testing and Materials (ASTM), the ASTM E2614-15 standard identifies important factors to consider when selecting a disinfectant for use in a clean room or similar controlled environment, and provides appropriate test methods for evaluating disinfectants. Appropriate disinfectant selection, along with proficiency testing, is a key element of a successful disinfection program. Disinfectants and antiseptics issued by the U.S. Department of Pharmacopoeia and by the U.S. Food and Drug Administration (FDA) Regulatory guidelines, such as sterile drug products produced through aseptic processing and current good manufacturing practice, require disinfectant efficacy testing, but do not clearly define acceptable testing methods.

An understanding of microbiological techniques is essential. At the same time, it is recommended to have knowledge in areas such as microorganisms, antimicrobial products (disinfectants, spore killers and decontaminating agents), disinfection chemistry, the mechanism of action of disinfectants on cells, application procedures, clean room surfaces and environmental conditions in the clean room.

The ASTM E2614-15 standard is intended for the cleanroom environment, but many of the principles outlined in this standard are applicable to production and processing environments other than the cleanroom. However, the evaluation of disinfectants for biofilm control is not within the scope of this standard.

Briefly, this standard includes:

• Requirements for aseptic processing areas include easily cleanable floors, walls and ceilings with smooth, non-porous surfaces
• Particle, temperature and humidity controls
• Cleaning and disinfecting procedures to create and maintain aseptic conditions

These controls, together with a careful and thorough evaluation of the chemicals used for the cleaning and disinfection program, should ensure adherence to specified cleaning standards and lead to control of microbial contamination of products. The qualification of disinfectants and verification of the cleaning and disinfection process in pharmaceutical, biotechnology, medical device facilities and related controlled environments are subject to regulatory review.

An effective cleaning and disinfection program in aseptic processing areas of a GMP regulated facility is critical to assuring product quality.

Our organization, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it has given for businesses in various sectors, within the scope of ASTM E2614-15 standard. It also provides standard testing services for the evaluation of clean room disinfectants.