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PDA TR 48-2010

Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance

This Technical Report addresses moist heat sterilizers intended for use in the pharmaceutical, medical device and biotechnology industries. This technical report focuses on the design and operation of moist heat sterilizers, from the development of User Requirements Specifications (URS) through equipment qualification (Installation Qualification (IQ) / Operational Qualification (OQ)) and culminating with ongoing maintenance requirements. The focus of this report does not include Performance Qualification (PQ). The reader is directed to PDA Technical Report No. 1 (2007 Revision) for discussion of load cycle development and process Performance Qualification.

Content Provider
Parenteral Drug Association [pda]

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