Radiation Sterilization of Medical Products – Beyond the Basics: 2-day In-person Seminar

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.

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.

We need the below information to serve you better

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.

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)
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
Day One (9:00 AM – 4:30 PM)
  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 Hemmerich
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
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.


Sunnyvale, CA(Venue to be announced shortly)

August 14-15, 2014
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Local Attractions:

Sunnyvale Heritage Park Museum
Located next to the Sunnyvale Community Center and Heritage Orchard, the museum is a replica of the original "Murphy Family Home". The Martin Murphy family, founders of the City of Sunnyvale, constructed the Murphy Family Home in the 1850s. In 1958, the Murphy family home was made a California State Historical Landmark. In 1961, the house was demolished by the city due to extensive damage following a fire. The Sunnyvale Historical Museum was dedicated and opened to the general public in September, 2008, as a testament to the history of Sunnyvale and the contributions made by the Martin Murphy family towards the founding of Sunnyvale.

Sunnyvale Art Gallery
The gallery showcases local artists with monthly rotating exhibitions. The gallery also houses a cafe, an art supply store, and a flower shop. The cafe is a spacious and quiet place great for studying. They also carry professional grade art supplies in their small art store. To encourage all forms of artistic expression, the gallery hosts an open mic every 1st and 3rd Thursday of the month.

The Lace Museum
The Lace Museum is a non-profit organization incorporated in 1981. It is the only lace museum in the western part of the United States and showcases one of the most extensive collections of lace and lace tools. The museum houses hundreds of tools, lace examples, books and other materials about the history of lace. The museum provides on-going needlework classes with experienced instructors. It is entirely staffed by volunteers and is supported by donations and the Lace Museum Guild. The museum also has a gift shop featuring one-of-a-kind vintage and contemporary tools and other items for needlework.

WeirdStuff Warehouse
This aptly-named store offers surplus and salvaged electronic equipment. Visitors and patrons describe it as a museum of technology where everything’s for sale, usually for extremely reasonable prices. Walking through its aisles will take you through the entire history of personal computing.
Mountain View
Mountain View is a city in Santa Clara County, in the San Francisco Bay Area of California. It is named for its views of the Santa Cruz Mountains. The city shares its borders with the cities of Palo Alto, Los Altos, and Sunnyvale, as well as Moffett Federal Airfield and the San Francisco Bay.

Sunnyvale Library
The Sunnyvale Library hosts a string of interesting activities year round including book clubs and Shakespeare readings. You can bring your own copy or use one from the library to run lines with fellow Shakespeare enthusiasts.

Baylands Park
Located near the beautiful San Francisco Bay, Baylands Park provides over 70 acres of developed parkland offering active recreation, pathways and picnic areas for families and large groups. An additional 105 acres of seasonal wetlands is protected as Wetlands Preserve providing habitat for plants and wildlife. Baylands Park is a successful joint venture between Santa Clara County which owns the property and the City of Sunnyvale which manages and maintains the Park. The park offers a variety of playgrounds and play structures for toddlers and small children too.