Contamination Control in Healthcare Product Manufacturing

PDA Technical Reports

Technical Report No. 67: Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices and Cosmetics

The purpose of TR 67 is to provide guidance to the nonsterile product manufacturing industry on how to manage the microbial risks associated with manufacturing and storage as well as how to determine what isolates would be deemed an objectionable microorganism in nonsterile products.

Technical Report No. 48: Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance

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.

Technical Report No. 13: Fundamentals of an Environmental Monitoring Program

PDA Technical Report 13 (Revised): Fundamentals of an Environmental Monitoring Program serves as a resource on controlled environmental test methods, and although some nonviable particulate information is included, the report's primary focus is microbiological control for sterile product manufacturing.

Technical Report No. 3 (Revised 2013): Validation of Dry Heat Processes Used for Depyrogenation and Sterilization

This technical report provides information to the manufacturers of pharmaceutical products for validating dry-heat depyrogenation and sterilization processes. The concepts and methods presented within this technical report are not intended to be a regulatory standard, but rather as points to be considered during the validation of dry-heat processes. Other technically equivalent methods may exist and may be used if they can be supported by sound scientific methods.

Technical Report No. 1 (Revised 2007): Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control

PDA’s original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. The revision retains a focus on the microbiology and engineering of moist heat sterilization and the general approach to sterilization science embodied in the original document, and updates it by including contemporary subject matter.