Medical products need to be validated for Radiation Sterilization

Do it right the first time” should be the mantra for medical device manufacturers that plan to make radiation products. Choosing the most functional and radiation resistant materials for their medical device will help them avoid the trouble of going through the post launch cycle of product revisions.

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To get this right, one simple line of thinking is crucial for medical device manufacturers to inculcate: To “think like a molecule”. This is the basis on which to plan and design around radiation induced changes in the qualities such as color, odor and brittleness that go into the materials.

Learning the right method

Professionals in the medical devices industry, who work on these aspects will benefit immensely from a two-day seminar on the topic, “Validating Radiation Sterilization for Medical Products”, which is being organized by GlobalCompliancePanel, a highly popular provider of professional trainings for all areas of regulatory compliance.

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The Director of this seminar, Karl J. Hemmerich, President of Ageless Processing Technologies, who brings over 35 years of experience in medical device product design, development, manufacturing, and sterilization, will offer a range of learning on this topic.

Identifying the best suited materials

Apart from helping participants identifying the materials that perform best upon radiation, keeping color and odor out of their irradiated products and enhancing product and packaging designs to take advantage of radiation; he will also offer understanding to them on how to avoid the materials that are certain to fail.

This seminar, for which medical device professionals can enroll by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900685SEMINAR?validating-radiation-Washington-DC, has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Understanding optimum sterilization modality

Participants will also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics and understand which modality (Gamma, E-beam, or X-ray) will perform best for their product.

Karl will cover the areas relating to validation of radiation sterilization for medical products, such as Materials Guidances – AAMI TIR # 17, ASTM, sterilization validation and bioburden, Shelf Life Test Methods – Accelerated Aging design, Test Design, Product Design, the influences of product assembly (molding, automation, etc.), material selection and post irradiation degradation, Regulatory Guidances – AAMI/ISO 11137, TIR #17, packaging design and materials, and biological polymers – tissue, serum at this two-day in person seminar.

The following areas will be covered at this seminar:

  • Polymers Chemistry – choosing the best polymer candidate
  • Gamma, E-beam, X-ray sterilization
  • Accelerated Aging
  • Product Qualification
  • Sterilization Validation – Establishing the Minimum Sterilization dose (VDmax)
  • Sterilization Modality Selection Criteria
  • Biocompatibility
  • Preventing Plastic Part Failure Post Irradiation

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