Web Code: MicroP2-11
Member/Nonmember Price: $75
The industry strives to manufacture and distribute pharmaceutical and biological/vaccine products for IV/IM administration that are sterile. After the product has been distributed and is in the hands of health professionals, additional manipulations are performed on the sterile products in preparation for administration to the patient. Any breach of the container/closure system carries a risk of accidental contamination. The risk may be small where simple manipulations are performed or may be large when additional pharmaceutical compounding must occur. Additionally, the use of single dose vials for vaccinations, especially in third world countries, can be difficult to manage. Multi-dose vials are more convenient. However, not all vaccines tolerate robust preservative systems. Regulations about vaccine storage and expiration dating may lead to large amounts of waste vaccine. Some products may be inherently antimicrobial, while others may be susceptible to microbial proliferation.The session will discuss the microbial quality of sterile drug products after the container/closure system has been breached. The session will also discuss the manufacturer responsibilities to understand the risk of microbial proliferation should accidental contamination occur. The second session will discuss the use of non-preserved multi-dose vaccines and what risks and benefits these products have in localities where the need for vaccination is high, but the storage and administration are difficult.
Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation Level of Expertise: Executives, Management, Scientists / Technicians
Dr. John W. Metcalfe, PhD, Review Microbiologist, CDER, Food and Drug Administration
Dr. Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD. in microbiology from the University of Rhode Island. Following his graduate studies, he worked as a college professor for a total of 14 years at Potsdam College of the State University of New York and Salem State College in Massachusetts where he taught microbiology related courses. During summers, John worked in several government (Natick Army Research Laboratories) and industry (Virus Research Institute and Avant Immunotherapeutics, Inc.) laboratories as a research microbiologist. John began his career at CDER in January of 2003, where he works as a review microbiologist.
Dr. Rudi Eggers, Team Leader Immunisation Services Strengthening Directorate: Immunizations, Vaccines and Biologicals, World Health Organisation (WHO)
Dr. Eggers served as Team Leader for the WHO Immunisation Intercountry Programme (ICP) in Eastern Africa in Nairobi, Kenya for six years before he joined the WHO headquarters in Geneva as Team Leader of the Immunisation Services Strengthening in the Directorate for Immunization, Vaccines and Biologicals in 2005. Dr. Eggers has worked with the vaccine pre-qualification team in WHO on the definition of the programmatic suitability of vaccine for pre-qualification criteria, and a the executive secretary of the Immunization Practices Advisory Committee (IPAC) of WHO. An expert in epidemiology and public health programmes, Eggers worked with the Department of Health, South Africa for six years and was holding the post of National Immunisation Programme Manager from 1995-1999. Dr. Eggers completed postgraduate degrees in Public Health and Health Administration after receiving his Medical and Surgical Degree, MBChB at the University of Pretoria.
Edward C. Tidswell, PhD, Senior Director, Research Sterility Assurance Technology Resources, Baxter Healthcare Corporation
Edward C. Tidswell, BSc, PhD - Dr. Tidswell is the Sr. Director of Sterility Assurance for Baxter Healthcare; located north of Chicago, IL (USA). His organization supports more than 40 facilities in this global strategic and tactical role which covers the entire breadth of microbiological control, sterilization and sterility assurance across a diversified healthcare company. More specifically assuring process and product control through research, development, implementation of new (or optimized) sterilization and aseptic technologies, PAT, end product testing, qualification and validation of sterile and aseptic manufacture for parenterals and medical devices. He has worked within bulk active pharmaceutical ingredient, vaccine and parenteral manufacturing operations for human health and animal health products in both technical and validation roles for the likes of Eli Lilly and Evans Vaccines. Dr Tidswell continues to actively publish and is a leading authority on risk, aseptic and sterile manufacture. In 2004 he received the Parenteral Society’s George Sykes Memorial Award for his contribution to pharmaceutical risk assessment. As a microbial physiologist Dr Tidswell retains an active interest in several areas of microbiology, which include: bacterial adhesion, quorum sensing, viability, anaerobes, and rapid microbial technologies. From 1995-2010 he has served on the Editorial Boards of Letters in Applied Microbiology and The Journal of Applied Microbiology. In June 2010 Dr Tidswell joined the USP expert committee on Microbiology & Sterility Assurance.
Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093