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.
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.
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
Materials Selection - Radiation Effects
AAMI - TIR # 17
Stress – Out of Our Parts, Out of Our Lives
Supplier Databases and Websites
Process Validation – Part II
Product and Process Design – It all starts in R&D
Critical Decision Points
The Shotgun vs a Targeted Approach
Bioburden Control and Epidemiology
Typical Causes and How to Fix Them
People and Processes
Choose a Good Partner and Save Time
Bioburden Counts – What does it Mean
IDs – Where did that come from?
Typical Causes and How to Address Them
DAY 02(9:00 AM - 4:30 PM)
Packaging – Design & Materials
Design Latitude – Pouches, Trays, Materials
Materials to be Avoided
Polypropylene and Polyethylene
Attributes – Design Limits
Unique Aspects of Different Product Types
Biologics and Tissue Sterilization Validation and Processing
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, ……