In this training course, guests will gain insight into the fundamentals of pharmaceutical elastomers with practical considerations. Industry experts will describe component selection strategies, review manufacturing technologies, component processing and sterilization techniques. There will be a focus to understand the origin of defects and analytical tools applied for their characterization. Be sure to register for our training courses. Click here to register online.
Agenda
Day 1
Introduction to Container Closure Systems and Pharmaceutical Elastomers (60 min)
- Vials, PFS, Cartridges (with a focus on elastomeric and aluminum components)
- Selection criteria and key considerations
- Physical and chemical properties
- Applications, variations, and functionalities
- E/L profiles
Pharmaceutical Elastomer Manufacturing Process (45 min)
- Manufacturing technologies
- Understanding critical manufacturing parameters
Processing of Elastomeric Components (45 min)
- Fundamentals of RFS and RTU components
- Importance of siliconization and selection criteria
- Basics of camera inspection
- Sterilization choices and elastomer packaging selection
Q&A (45 min)
Day 2
Elastomeric Testing (60 min)
- Understanding origin of defects
- Defect classification (discussion of PDA TR76)
- Commonly applied analytical methods
- Test methods discussion (e.g. CCI, silicone, moisture retention, chemical identification)
Regulatory Requirements Applicable to Elastomeric Closures and Aluminum Seals (60 min)
Introduction to Aluminum Seals - Manufacturing Technologies and Processes (15 min)
Q&A (60 min)
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