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
Equipment Qualification, which may include Factory
Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning
On-going control requirements
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.
Available to downloadClick here for the digital downloading instruction and Terms of Usage.
Format: PDF (1 file 944 KB)
*To purchase licensing, please contact PDA at [email protected]
Click here to order paper ship version (Item no. 01048).
Table of Contents:
Click here to download >>> Table of ContentsIntroduction
Glossary of Terms
Comprehensive Sterilizer System Design
Equipment Verification & Qualification