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Saturday, September 12, 2009

Classification of Air Cleanliness rely solely ISO 14644 1 ISO 14644 2 qualifying facility

Should a pharmaceutical manufacturer of sterile drug products which produces sterile drugs by aseptic processing rely solely on ISO 14644-1 and ISO 14644-2 when qualifying their sterile dosage form manufacturing facility?

As per the USFDA guidelines , a pharmaceutical manufacturer of sterile drug products who produces sterile drugs by aseptic processing should not rely soley on ISO 14644-1 and ISO 14644-2

This is generally not acceptable from a current good manufacturing practice (cGMP) perspective for a pharmaceutical manufacturer of sterile drug products which are produced by aseptic processing to rely solely on
ISO 14644-1 Part 1: Classification of Air Cleanliness ("14644-1") and
ISO 14644-2 Part 2: Specifications for Testing and Monitoring to Prove Compliance with ISO 14644-1 ("14644-2")

when qualifying their manufacturing facility.

Rather, a manufacturer of sterile drug products who produces sterile pharmaceuticals by aseptic processing should use these ISO standards in combination with applicable US FDA regulations, guidance and other relevant references to ensure a pharmaceutical facility is under an appropriate state of control. Consequently, appropriate measures augmenting ISO's recommendations (e.g., with microbiological data) would likely be expected for a firm to meet or exceed CGMP in a pharmaceutical facility.

US FDA answer to the question says that 14644-1 and 14644-2 have superseded Federal Standard 209E, Airborne Particulate Cleanliness Classes in Clean rooms and Clean Zones ("Federal Standard 209E").  In November 2001, the U.S. General Services Administration canceled Federal Standard 209E.
While not US FDA regulations or US FDA guidance, the Agency believes 14644-1 and 14644-2 are useful in facilitating the international harmonization of industrial air classification for non-viable particle cleanliness in multiple industries (e.g., computer, aerospace, pharmaceutical). 

As such, US FDA adopted these particle cleanliness ratings in the 2004 guidance for industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice.  However, due to the unique aspects of producing sterile drug products by aseptic processing (e.g., microbiological issues) an aseptic processing manufacturer should not rely solely on 14644-1 and 14644-2 when qualifying their facility.
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