2011 Micro Conference - B2: Challenges in Radiation Sterilization of Pharmaceutical and Medical Devices

Web Code: MicroB2-11
Member/Nonmember Price: $75

Seminar Summary

Radiation sterilization has become the method of choice for sterilization of heat sensitive pharmaceutical products and for medical devices. The delivery and validation of a specific dose to a medical product/device is critical when using radiation sterilization. The sterilization dose is impacted by material interactions, radiation stability, and bioburden. This seminar will cover factors important in the development, validation, and control of a radiation sterilization process. The challenges faced in the design of a sterilization plan and tools to improve success rates for irradiation of active pharmaceutical ingredients and fillers or inert materials will be discussed. Continued interactions between manufacturers and sterilization centers are crucial for the process. The seminar will conclude with the evaluation of radiation sterilization process during device inspections and a discussion of irradiation facility related issues.

Who Should Attend

Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation Level of Expertise: Executives, Management, Scientists / Technicians

Presenters Bio

Joyce Hansen, President , J.M. Hansen & Associates

Joyce Hansen is a consultant to the medical device, pharmaceutical and tissue product industries, with more than 26 years of experience in the field of sterilization, quality systems, research & development, and management of facility and corporate level sterility assurance functions.

In 2005, Joyce founded JM Hansen and Associates to build a practice which provides manufacturing companies with strategic plans for optimized use of internal sterilization equipment or the use of contract sterilization and laboratory services.  The strategic plans focus on validation of the appropriate sterilization process (radiation, ethylene oxide, moist heat, etc.) to meet regulatory requirements.  She specializes in the area of radiation (gamma, electron beam and x-ray) and ethylene oxide sterilization.  She has provided technical support for product and process problem solving, educational seminars, and resolution of U.S. and International regulatory compliance issues.

Prior to becoming a consultant, Joyce spent 6 years (from 1998 to 2004) working for Baxter Healthcare Corporation, a world-wide leading supplier of healthcare products, systems and services as Vice President, Sterility Assurance and Sterilization Core Technical Competency (CTC) Champion.  In this position she was responsible for directing personnel that supported product development, sterilization technical support to worldwide operations, and sterilization research and development.

Joyce was the Director, Global Sterility Assurance for Sherwood Davis & Geck (1997 to 1998) and was responsible for the sterilization operations worldwide (radiation, ethylene oxide, moist heat, contract sterilization) and sterility assurance laboratories worldwide (microbiology, chemistry and toxicology).

Previously, Joyce held the positions:
Director, Sterilization Science Center for Baxter Healthcare Corporation where she was responsible for the development of a new department that specialized in sterilization research and development;
Vice President, Regulatory Affairs/Quality Assurance for Isomedix (a contract firm offering gamma and ethylene oxide sterilization); and
several positions of increasing responsibility at Becton Dickenson & Company plant manufacturing, research and corporate faciltiies.

Betty Howard, Radiation TechTeam Manager, STERIS Isomedix Services

Ms. Howard has been with STERIS since 2002 and manages Technical Support and dose validation activities for irradiation processing. Betty has over 20 years experience in Biotechnology Research, applications development and technical support related to drug discovery, analytic instrumentation, microbiology, biochemistry including previous positions with Amersham , PerkinElmer, Illinois Department of Public Health. She holds a BS and MS degree from the University of IL in biological Sciences and an MBA in Marketing and General Business

Patrick B. Weixel, Consumer Safety Officer, CDRH, Office of Compliance, Quality System Team

Patrick Weixel has been a Consumer Safety Officer with the Food and Drug Administration (FDA) for nineteen years.  He began his FDA career as an investigator in 1992 and primarily conducted medical device inspections.  In 1999 Mr. Weixel received his Level II Investigator Certification in Medical Devices from the Office of Regulatory Affairs/FDA.  In July of 1999 Mr. Weixel accepted a position in the Office of Compliance/Center for Devices and Radiological Health.  In the Office of Compliance his primary responsibilities include the review of establishment inspections reports and regulatory actions, and conducting reviews for the Office of Compliance that involve industrial sterilization issues.  He is also involved in assignments dealing with reprocessing of single use devices.

Mr. Weixel regularly participates in sterilization standards meetings and is the FDA Primary Representative for the following standards committees:

Association for the Advancement of Medical Instrumentation (AAMI) – Radiation Sterilization Working Group

American Society of Testing and Materials (ASTM) International – E10.01 Committee – Radiation Processing: Dosimetry and Applications and F02 - Flexible Barrier Packaging Materials.

Mr. Weixel a received his Bachelor of Science degree from Frostburg State University in 1989.

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org