PDA TR 48

PDA's Moist Heat Sterilization Systems Task Force has developed a scientific technical report that will help you design and operate moist heat sterilizers. Advise is offered on the following areas:

• Setting User Requirements and Specifications
• Design Qualification (DQ)
• Equipment and Control System Design
• Functional Requirements for the moist heat sterilizer and expectations for utilities supporting the sterilizer
• Equipment Operation, including calibration and maintenance
• Equipment Qualification, which may include Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning
• On-going control requirements
• Cycle Development

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.