Complete Revision of USP Chapter <1116> including updated Cleanroom Classification

In the Pharmacopeial Forum 36, number 6, the USP published the proposal of a complete revised version of chapter <1116>  Microbiological Evaluation of Clean Rooms and Other Controlled Environments". The proposed revision includes a change of the title to "Microbiological Control and Monitoring of Aseptic processing Environments".

The revision caused several necessary changes, amongst others, the change of the clean room classification standards from Federal Standard 209E to ISO 14644 in subchapter "Clean Room Classification for Aseptic Environments" and the developments in advanced aseptic technologies. In their contents and in the included tables the revised subchapters refer to the requirements for such advanced aseptic technologies like isolators and restricted access barrier systems (RABS). Consequently, subchapters like "Training of Personnel" have to be adapted to the new requirements of these technologies as well.

This chapter of the USP is supposed to provide guidance for microbiological evaluation for clean rooms, restricted access barrier systems (RABS) and isolators used for aseptic processing. ISO classified environments which are used for other purposes or for non sterile applications must not implement these levels of contamination control required for aseptically produced sterile products. They normally need other microbial control strategies.

Please note the ECA education course "Contamination Control", in Prague, Czech Republic, from 29-31 March 2011. This course covers the different aspects of contamination control, from microbial background to preventive measures like disinfection and clean room garment. Experienced speakers from Industry and consulting will share and discuss their practical knowledge with you.

Axel Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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