Contamination Control in Healthcare Product Manufacturing

Recent Research/Technology Articles

Oct 13, 2017
Oct 13, 2017

PDA Sterile Processing Interest Group on PDA Connect

Join the conversation on PDA Connect. The PDA Sterile Processing/Parenteral Drug Manufacturing Interest Group's Connect website allows members to post discussions, interact with peers, and keep up with the latest in science, technology, standards, regulations and conference events. The mission of this group is advancing understanding of existing and cutting edge sterile processing and parenteral drug manufacturing internationally. 

Check out the latest conversation.

This community is open to PDA members only. Join PDA! 

Technical Books

Environmental Monitoring: A Comprehensive Handbook, Vol. 7
Jeanne Moldenhauer, Editor

This is volume 7 of the Environmental Monitoring Handbook series. Each volume of this series discusses different aspects of environmental monitoring. One of the first topics discussed in this volume is the topic of cleanrooms and ways to prevent contamination. Subject matter experts Dr. Tim Sandle, Jan Eudy, Jim Polarine, John Lindsay and others describe new and/or better ways to do things.

Purchase this book. 

 

Global Sterile Manufacturing Regulatory Guidance Comparison: With link to Comparison Spreadsheet

Compares regulatory guidance documents issued by the U.S. FDA, the EU, the Pharmaceutical Inspection Convention/Scheme and the World Health Organization. Within the document, you will find analysis and comparison tables that are easy-to-use references for companies that need to adhere to the four regulatory documents; the spreadsheet allows companies to do their own assessment of their status for each element.

Purchase this book. 

 

PDA Technical Reports

PDA Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations

TR-69 presents the current scientific understanding of the causes of and control strategies for bioburden in pharmaceutical production systems, with a special emphasis on biofilms in fluid-handling systems. Both large and small molecule production are covered.

Points to Consider for Aseptic Processing: Part 1

Updates 2003 edition with revisions based on the impact of knowledge gained in the industry as determined by a task force of subject matter experts. The revision provides positions on current topics, best practices, and areas of clarification that are important to the manufacturing of quality sterile products. 

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About PDA and Sterile and Aseptic Processing

PDA was founded in 1946 as the Parenteral Drug Association by a small group of pharmaceutical manufacturers who recognized the need for an organization to disseminate technical information within the industry. Today, coordinated through its headquarters and its Training & Research Institute in Bethesda, Maryland, PDA volunteers worldwide carry out its mission of promoting the exchange of rapidly evolving information on the latest technology and regulations concerning high-quality pharmaceutical production.
 
PDA is the recognized authoritative voice and leading technical organization in the field of parenteral science and technology. Through the development of Technical Reports and responses to regulatory initiatives, PDA and its members influence the future course of pharmaceutical products technology.