ABSTRACT
International Organization for Standardization (ISO) standard 14644-1, Cleanrooms and Associated Controlled Environments-Part 1, Classification of Air Cleanliness; and ISO standard 14644-2, Cleanrooms and Associated Controlled Environments-Part 2, Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1. European countries have adopted these ISO standards, and in the United States, both documents replaced the Federal Standard 209 in November 2001. ISPE Baseline Guide Volume No 6, Biopharmaceutical Manufacturing Facilities. ISPE Baseline Guide Volume No. 3, Sterile Manufacturing Facilities. FDA Guide-Sterile Drug Products Produced by Aseptic Processing (2004).
