Biofilm Control in Drug Manufacturing (single user digital version)

Table of Contents:

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1. The Contamination Control by Design (CCbD©) Model — A Proactive Approach to Contamination Control by Carmen M. Wagner
2. Biofilm Basics by Paul J. Sturman
3. Microbial Contamination Control Considerations in Biopharmaceutical Production by Lucia Clontz
4. Establishing Microbial Contamination Control in Drug Manufacturing Through Risk Management by Karin Zink McCullough
5. Controlling Biofilms in Drug Manufacturing Equipment by Mark Pasmore and Robert Fry
6. Investigating the Link Between Contamination in the Manufacturing Environment and Patient Safety by Mark Hunter, Michelle Luebke and Mark Pasmore
7. Detection, Prevention and Control of Biofilms in Pharmaceutical Water Systems by Teri C. Soli
8. Biofilm Detection and Data Management by Teri C. Soli
9. Early Detection and Prevention of Biofilms in Process Equipment by Mark Fornalik
10. Sanitization Approaches for Biofilm Control by Teri C. Soli
11. Disinfectant Efficacy Studies Using Biofilm Reactors by Lucia Clontz

• Conclusion: Future Trends in Biofilm Prevention, Control, and Remediation by Lucia Clontz and Carmen M. Wagner
• Appendix

About the Editors

Dr. Lucia Clontz is an expert microbiologist and the Senior Manager, Compliance at Fresenius Kabi USA, in Raleigh, NC, USA. Dr. Clontz is also an adjunct instructor at the Biomanufacturing Training and Education Center (BTEC) at the North Carolina State University, in Raleigh, NC, USA. For more than 25 years Dr. Clontz has managed numerous validation projects, implemented/ improved quality systems, and participated in compliance audits. She has successfully developed innovative approaches to the application of microbiology in pharmaceuticals and is a wellregarded instructor, presenter and author in the area of pharmaceutical microbiology and contamination control. Dr. Clontz has B.S. degrees in Chemistry, minor in Chemical Engineering, and in Marine Sciences. She also holds a Master of Science degree in Microbial Biotechnology and a Doctorate in Health Sciences. Her doctoral applied research project evaluated the synergistic effect of an antibiofouling chemical, developed by professors at the North Carolina State University, and antibiotics to prevent and disrupt biofilms of clinically relevant bacteria. Dr. Clontz is co-founder of the Pharmaceutical Microbiology Forum (PMF) and the BiofilmNetworking Group (BNG), and co-developer of the Contamination Control by Design (CCbD) concept. Dr. Clontz is a member of the USP Pharmaceutical Waters Expert Committee (2005-2010) and Panel (2010-2015) and the PDA Bioburden and Biofilm Management Task Force (2011-2012).

Dr. Carmen M. Wagner has over twenty-eight years of experience in the health industry and is founder and President of Strategic Compliance International, Inc (SCI). Dr. Wagner has consulted with several clients, successfully carrying out assignments in the US and abroad, independently and in affiliation with other consulting firms. Since 1999, Dr. Wagner has serviced multinational, as well as mid-sized and small start-up biotech companies. Dr. Wagner started her pharmaceutical career as a Research Associate, progressing to positions of responsibility in Technical Operations, QA, and Regulatory Compliance. She has worked for academic/research institutions and multinational, Fortune 100 companies. In her management capacity, she has lead several new product quality control teams, directed product problem resolution, CMC section development, and participated in the development of quality policies, development of product specifications and cross-site technology transfer projects. Corporate management experience includes tenures at E.I. Du Pont, Johnson & Johnson, American Cyanamid, Wyeth, and MERIX Bioscience.

Dr. Wagner also enjoys working on workforce development and has incorporated workforce training, mentoring and coaching in her list of services. In 2002, she co-founded Hot Topics Workshops (www.hottopicsworkshops.com), with International Regulatory Affairs Services, Inc to provide cost-effective workforce development worldwide. Through Hot Topics Workshops she teaches companies to build an effective workforce ready to incorporate GMPs into product development and execute technology transfer and outsourcing projects to expedite product launches.