Electronic PDA Technical Reports

PDA Technical Report No. 48 (TR 48) Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance (single user digital version)

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.

    Available to download
    Format: PDF (1 file 944 KB)

    Click here for the digital downloading instruction and Terms of Usage.

    *To purchase licensing, please contact PDA at info@pda.org

    Click here to order paper ship version (Item no. 01048).

  • Table of Contents:

    Click here to download >>> Table of Contents

  • Introduction
  • Glossary of Terms
  • Sterilization Processes
  • Comprehensive Sterilizer System Design
  • Equipment Verification & Qualification
  • Cycle Development
  • On-Going Control
  • Documentation
  • Appendix
  • References

  • Date of Publication: May 2010
    ISBN Number: 9780939459292
    Format: PDF
    Number of Pages: 64