The ASTM E2614-15 standard, developed by the American Society for Testing and Materials (ASTM), defines key factors to consider when selecting a disinfectant for use in a cleanroom or similar controlled environment and provides appropriate test methods for evaluating disinfectants. Selection of an appropriate disinfectant, along with proficiency testing, is a key element of a successful disinfection program. Regulatory guidelines such as those published by the U.S. Pharmacopoeia Division on disinfectants and antiseptics and by the U.S. Food and Drug Administration (FDA) on sterile pharmaceutical products manufactured through aseptic processing, and current good manufacturing practices, require disinfectant efficacy testing but do not explicitly define acceptable test 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:
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.
Among the numerous tests, measurements, analyses, and evaluations our organization provides for businesses in various sectors, we also offer standard testing services for the evaluation of cleanroom disinfectants under the ASTM E2614-15 standard, utilizing a trained and expert staff and advanced technological equipment.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
