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Radiation Sterilization of Medical Products - Beyond the Basics  

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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

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Seminar Summary:

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. (see full course description)

 

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Training Course Syllabus:


Radiation Sterilization of Medical Products - Beyond the Basics

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:

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.

DAY 01(8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Review of the radiation sterilization – modalities, history, strengths and limitations, terms, processing parameters.
History/Terms
Gamma, E-beam, X-ray – Is there a best choice?
Irradiator Designs and Processing Variables
Dose Rate and Distribution
Costs - Contractors, In-house Systems
Process Validation – Part I
History – Kilmer and Beyond
VD Max
Method 1
Method 2
Dose Audits
Materials Selection - Radiation Effects
Polymer Chemistry
AAMI - TIR # 17
Guidance Offered
Desirable/Undesirable Changes
Brittleness
Color Change
Odor
Hardness/Softness
Films, Adhesives
Crosslinking/Toughness
Stress – Out of Our Parts, Out of Our Lives
Supplier Databases and Websites
Process Validation – Part II
Bioburden Sampling
Sterility Testing
Family Grouping
Dose Audits
Product and Process Design – It all starts in R&D
Critical Decision Points
The Shotgun vs a Targeted Approach
Molding/Extrusion
3D Printing
Bioburden Control and Epidemiology
Environmental Control
Control Levels
Bioburden Excursions
Typical Causes and How to Fix Them
People and Processes
Laboratory Issues
Choose a Good Partner and Save Time
Bioburden Counts – What does it Mean
Recovery Efficency
IDs – Where did that come from?
Sterility Failures
Typical Causes and How to Address Them
Planning Timeline
Basic Biocompatibility

DAY 02(9:00 AM - 4:30 PM)

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

Seminar Summary:

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. (see full course description)

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