ASTM E2614 - 15(2020)e1

Standard Guide for Evaluation of Cleanroom Disinfectants


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 42.25

Scope

1.1 This guide identifies important factors to consider when selecting a disinfectant for use in a cleanroom or similar controlled environment and recommends test methods suitable for evaluating disinfectants. The proper selection of disinfecting agent combined with qualification testing is a key element of a successful disinfection program. Regulatory guidance such as United States Pharmacopoeia Chapter <1072>, “Disinfectants and Antiseptics” and the FDA Guidance for Industry, “Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice” address the necessity of disinfectant effectiveness testing but do not clearly define acceptable test methods.1.2 An understanding of microbiology and microbiological techniques is essential. Knowledge in the following areas is recommended: microorganisms, antimicrobial products (disinfectants, sporicides, and decontamination agents), the chemistry of disinfection, mechanism of activity of disinfectants on cells, applicat

Number of pages: 5

International relationships :

ICS: 13.040.35 - Cleanrooms and associated controlled environments

Item number: A011449