ISO/AWI 14644-20

A working group has prepared a draft.

Abstract

This standard will establish recommendations and methodology for demonstrating microbiological contamination control in cleanrooms and clean controlled environments. This standard will be limited to viable microbiological contamination control and excludes any considerations of endotoxin, prion and viral contamination. This standard provides guidance for common applications, including Pharmaceutical, Biopharmaceutical, Medical Device, Hospitals and Food.