Medical Elastomer Technology
Date: November 4, 2009 (AP8410)
Time: 8:30 a.m. - 4:30 p.m.
Cost: $495.00 USD
CEU's: .75
Instructor: Dr. Thomas Gurley
Location: Akron Polymer Training Center, Akron, OH 44325-5404
Course Overview: This course focuses on elastomers/compounds used in medical applications both closures for parenteral drugs and components for medical devices. This class will give an in-depth look at elastomeric formulations including the ingredients - polymers, curatives, fillers, processing aids, antioxidants and colorants. It will cover the vulcanization, mixing, rheology and molding including properties of cured parts - functional and physical. A strong emphasis will be on the extractable profiles, pharmacopiea comparisons, current vendors, competitive analysis and case studies of solving real problems with analytical science.
Course Outline:
- Polymers in general - plastics, elastomers and thermoplastic elastomers
- Elastomers used in pharma applications
- Chemistry of elastomers
- Cure systems
- Fillers inorganic minerals
- Processing aids
- Colorants
- Degradation inhibitors antioxidants/antiozonants
- Vulcanization - curing process
- Stopper manufacturing - mixing, molding and finishing
- Rheology of elastomers
- Current commercial formulations overview - Helvoet, Itran, Stelmi and West
- Extractable fingerprint approach to characterizing current formulations
- Stopper coatings and manufacturing processes
- Extractable profiles related to drug interactions
- Pharmacopiea comparisons/evaluation
- Current studies related to extractables/leachables
- Real life detective stories - solving real problems with analytical science
- PVC chemistry