2021 - Radiation Sterilization of Medical Products - Beyond the Basics

Day 01(9:00 AM - 5:00 PM EDT)
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 - 5:00 PM EDT)
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, ……