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Radiation Sterilization of Medical Products - Beyond the Basics

By:
Karl J. Hemmerich,
President- Ageless Processing Technologies
Martell Winters,
Senior Scientist - Nelson Laboratories
Coming soon.. Please contact customer care for new schedule

Course "Radiation Sterilization of Medical Products - Beyond the Basics" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Learn from two of the foremost validation, materials, and operations leaders in the marketplace. The course instructors have decades of experience in microbiology, validation, operations on traditional as well as tissue/biologic and combination products. Save time and money by attending this course dedicated to increasing your knowledge in radiation sterilization.

Course Description:

This two day highly interactive course will cover all aspects of radiation sterilization validation, materials selection and processing implementation. This workshop has been designed to help attendees learn the ins and outs of all the radiation modalities, materials selection, and validation of the sterilization process per ISO 11137.

Additionally, 483 case studies will explore how to avoid the operational and legal issues that arise from nonconformance with regulators (FDA) and auditors.




Learning Objectives:

Upon completing this course on radiation sterilization, participants will:

  • Understand how to select product polymer materials for optimal product performance after radiation sterilization processing.
  • Know how to complete an optimal validation test design – inclusive of dose, dosimetry, sample size, accelerated ageing, ASTM standards, and thermal analysis.
  • Understand the effect of product design and assembly on bioburden, product safety and the success in executing the validation journey.
  • Understand all the foundations of a successful radiation sterilization program – materials, bioburden, validation, maintenance of validation.
  • Understand the impacts of all regulatory guidances on the radiation sterilization process.
  • Perform risk assessments effectively.
  • Understand where companies miss the mark in triggering, investigating and executing bioburden action levels and quarterly sterilization audits.


Who will Benefit:

This course is designed for medical device, biologic products, and pharmaceutical professionals who desire to get a complete understanding of the validation and use of radiation sterilization for their products. Following personnel will benefit from the course:

  • Senior quality managers
  • Sterilization managers
  • Quality professionals
  • Regulatory and Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • R&D engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal professionals





Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (9:00 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Review of the radiation sterilization – modalities, history, strengths and limitations, terms, processing parameters.
    1. History/Terms
    2. Gamma, E-beam, X-ray – Is there a best choice?
    3. Irradiator Designs and Processing Variables
    4. Dose Rate and Distribution
    5. Costs - Contractors, In-house Systems
  2. Process Validation – Part I
    1. History – Kilmer and Beyond
    2. VD Max
    3. Method 1
    4. Method 2
    5. Dose Audits
  3. Materials Selection - Radiation Effects
    1. Polymer Chemistry
    2. AAMI - TIR # 17
      • Guidance Offered
    3. Desirable/Undesirable Changes
      • Brittleness
      • Color Change
      • Odor
      • Hardness/Softness
      • Films, Adhesives
      • Crosslinking/Toughness
    4. Stress – Out of Our Parts, Out of Our Lives
    5. Supplier Databases and Websites
  4. Process Validation – Part II
    1. Bioburden Sampling
    2. Sterility Testing
    3. Family Grouping
    4. Dose Audits
  5. Product and Process Design – It all starts in R&D
    1. Critical Decision Points
    2. The Shotgun vs a Targeted Approach
    3. Molding/Extrusion
    4. 3D Printing
  6. Bioburden Control and Epidemiology
    1. Environmental Control
    2. Control Levels
    3. Bioburden Excursions
      • Typical Causes and How to Fix Them
      • People and Processes
  7. Laboratory Issues
    1. Choose a Good Partner and Save Time
    2. Bioburden Counts – What does it Mean
      • Recovery Efficency
      • IDs – Where did that come from?
    3. Sterility Failures
      • Typical Causes and How to Address Them
    4. Planning Timeline
  8. Basic Biocompatibility

  1. Packaging – Design & Materials
    1. Regulatory Requirements
    2. Design Latitude – Pouches, Trays, Materials
    3. Materials to be Avoided
    4. Breathability Requirements
  2. ISO/AAMI/FDA Standards
    1. ISO 11137-1
    2. ISO 11137-2
    3. ISO 11137-3
    4. TIR #
    5. FDA Guidance
  3. Unique Materials
    1. Polypropylene and Polyethylene
    2. PC, Polyester,
  4. Product Validation
    1. Dose Limits
    2. Attributes – Design Limits
    3. Accelerated Aging
  5. Unique Aspects of Different Product Types
    1. Biologics and Tissue Sterilization Validation and Processing
    2. Pharmaceuticals
    3. Combination Products Sterilization
  6. Product Validation Summary/Planning… Planning…Planning
  7. Learning from 483’s - Case Study Exercise from current FDA Warning Letters
  8. The SAL Debate
    1. 10-6, 10-3, 10-4
    2. North America, Europe, ……





Meet Your Instructors

Karl J. Hemmerich
President- Ageless Processing Technologies

Mr. Karl J. Hemmerich, President of Ageless Processing Technologies, has over 35 years of experience in medical device product design, development, manufacturing, and sterilization. He specializes in sterilization method selection and program development with emphasis on component material selection, process development and sterilization process validation. Karl has extensive experience in radiation sterilization with over 10 years in management of a gamma processing facility, as well as a technical resource for Customers with materials and dose related product issues. Karl made numerous presentations at Customer sales seminars, industry technical conferences and the FDA. Some of the subjects covered included radiation compatibility and selection of materials (i.e. radiation grade polypropylene), gamma processing, dosimetry, package design, validation test design, preventing part failure through enhancements in processing and product design, and accelerated aging.

In 2004 Medical Device and Diagnostics Industry selected Mr. Hemmerich as one of the 100 Most Notable People in the medical device industry. He holds numerous medical device patents and is a member of American Society of Mechanical Engineers, American Society for Quality Control and the Society of Plastics Engineers. He has written and presented papers on sterilization and materials selection for many corporations, universities and professional organizations, including MDDI, SPE, FDA, HIMA, & ASQC, and his paper on radiation effects on polymers published in Medical Device and Diagnostics magazine remains an industry standard (www.mddionline.com/article/polymer-materials-selection-radiation-sterilized-products ). He has taught courses in Radiation Sterilization of Medical Polymers and Preventing Plastic Part Failure through the College of Engineering, University of Wisconsin. He is a contributing member of the AAMI SWG96/ISO11137 “Radiation Materials Working Group” that developed Technical Information Report # 17 as the guidance for materials selection, qualification/validation test techniques and quality processing methods for all common sterilization methods. Mr. Hemmerich is Co-director of the Editorial Advisory Board for MDDI magazine where he offers forward looking guidance as well as technical review for state-of-the–art articles prior to publication.


Martell Winters
Senior Scientist - Nelson Laboratories

Martell Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University. Mr. Winters has been at Nelson Laboratories for 20 years and spent most of that time working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue and pharmaceutical products. He is currently a Senior Scientist for Nelson Laboratories.

Mr. Winters serves on many AAMI Sterilization Working Groups. He is also on the AAMI Sterilization Standards Committee and is the AAMI liaison to the AATB Standards Committee. In 1995 he received his Registered Microbiologist (RM) certification, and in 2001 his Specialist Microbiologist (SM) certification in consumer products and quality assurance microbiology from the U.S. National Registry of Microbiologists.






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