1:30PM –1:55PM

Abstract:
Conventional sterilization technologies, such as ethylene oxide and irradiation, have been established for more than 40 years. As medical device technologies evolve, new requirements for sterilization methods are now needed that can meet challenges in product development, supply chain, and regulatory aspects.

The seminar will discuss the implementation of alternate and nontraditional sterilization methods. Participants will learn about different sterilization methods, regulatory pathways, standards for sterilization validation and required testing in sterilization. Upon completion of this seminar, attendees would be able to:

a. Address traditional methods versus nontraditional sterilization methods;
b. Understand FDA guidance documents, regulatory pathways and validation of non-traditional sterilization methods;
c. Consider sterilization process development, packaging, and integration with manufacturing and supply chain; and
d. Compare aseptic processing versus terminal sterilization.

We will discuss:

a. Sterilization methods and issues;
b. Traditional versus nontraditional sterilization methods;
c. Regulatory pathways and validation of non-traditional sterilization methods;
d. Consideration of packaging, integration with manufacturing and supply chain;
e. Aseptic processing versus terminal sterilization.

Intended audience: Professionals who work in the following areas: manufacturing, microbiology, process engineering, product design, quality assurance, quality control, regulatory affairs, research and development, validation, or any personnel involved in sterilization

About the speaker(s)
Mike, Valentine, Director of REVOX Sterilization Services
Mike Valentine is the Director of REVOX® Sterilization Services for Minntech – Infection Prevention & Control Chemistries Group. Prior to Minntech, Mike worked for Johnson & Johnson in progressive marketing, sales and business development roles including Worldwide Director for the Scientific & Industrial Business of Advanced Sterilization Products division. Mike brings over twenty five years of experience in providing novel sterilization solutions for medical device, pharmaceutical and research applications. Mike's expertise includes medical device sterilization and packaging, global medical device regulations, pharmaceutical aseptic and terminal sterilization processes. Mike is well versed in steam, ethylene oxide, hydrogen peroxide gas plasma, chlorine dioxide and other sterilization methods.