Validating the Sterilization Process for a NEW Medical Device

Karl Leinsing
Instructor:
Karl Leinsing
Date:
Thursday, July 21, 2016
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 500950

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Price Detail Options
Overview:

Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

The following subjects will be covered in detail:

  • AAMI TIR # 17 - Sterilization Modalities and Materials Guidance's
  • Sterilization validation and Bioburden - D-value
  • Shelf Life Test Methods - Accelerated Aging design
  • Product design
  • The influences of product assembly (molding, automation, etc.)'
  • Material selection and post sterilization degradation
  • Regulatory Guidance's - AAMI/ISO 11137, AAMI/ISO 11135, etc.
  • Packaging Design and Materials

Why should you Attend: "Do it right the first time", choose the design and material for your medical device instead of going through the post launch cycle of product revisions. Learn the basics for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics.

Learn how to "think like a molecule" and plan and design around sterilization constraints and product/materials qualities (color, odor, brittleness). Learn about:
  • FDA's Traditional and Non-Traditional Sterilization Modalities
  • Identify the materials that perform best in a given sterilization modality
  • Keeping color, odor, and residuals out of your products
  • Restraints on Package Designs. Enhance product and packaging designs to take advantage of any given sterilization modality
  • Which modality will perform best for my product
  • Restraints on Package Design and Maintenance of Package Integrity


Areas Covered in the Session:
  • Sterilization Modality Basics and Selection Criteria
  • Polymers Chemistry - choosing the best polymer candidate
  • Radiation (Gamma, E-beam, X-ray), Ethylene Oxide, Moist Heat, Dry Heat, H2O2, Vaporized Chemical sterilization, Ozone, NO2
  • Sterilization Validation - Establishing the baseline cycle/dose
  • Accelerated Aging
  • Product Validation
  • Production Considerations and Assembly Techniques

Who Will Benefit:
  • Medical product design Engineers
  • Sterilization Experts
  • Quality Management and Engineers
  • Regulatory Affairs
  • Project Managers
  • Purchasing and Supply Chain Managers
  • Staff evaluating risk, safety, and effectiveness
  • R&D Staff - engineering and lab personnel
  • Process Engineers
  • Packaging Engineers
  • Materials Engineers
  • Manufacturing Engineers


Speaker Profile
Karl R. Leinsing has experience with design and project management since 1988 and has been in the Medical Product Device Design and Development industry since 1992. His areas of expertise include full life cycle product development, product conception, polymer selection, thorough computer-aided product design, dynamic mechanical analysis and root cause analysis, molding and manufacturing, project organization, technical presentations and leadership, and cross-functional teamwork. Karl currently holds 19 patents (several patents pending), 5 design awards, was listed as one of "100 notable people in the Medical Device Industry" by Medical Device and Diagnostic Industry (MDDI), and was inducted into the Product Design & Development Engineer Hall of Fame.

Karl has a Masters of Science Degree in Mechanical Engineering from North Carolina A&T State University and a Bachelor of Science Degree in Mechanical Engineering from the University of New Hampshire. He is a licensed professional engineer in New Hampshire and has lectured Medical Device and Manufacturing (MD&M) Seminars on The Science of Successful Product Design. Karl Leinsing serves on Eureka Medical's Board of Advisors and reviews and evaluates new medical product ideas for this company along with its other distinguished members. He also serves on the Inventor's Workshop Board of Directors to review new products for the promotional and retail industry.


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