Future Oriented Materials for Prefilled Syringe Components
Renaud Janssen
Helvoet Pharma
Industrieterrein Kolmen 1519, BE-3570 Alken, Belgium
Tel: +45 3211 590878 Fax: +45
3211 590923
Email: renaud.janssen@helvoetpharma.be
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Future Oriented Materials for Prefilled Syringe Components
Renaud Janssen
Helvoet Pharma Industrieterrein Kolmen 1519, BE-3570 Alken, Belgium
Tel: +45 3211 590878 Fax: +45
3211 590923 |
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Biography
Renaud Janssen graduated as a chemical engineer from Leuven University, Belgium. After finishing his doctoral study he joined Janssen Pharmaceutica in Belgium, where he worked in the Department of Chemical Development and Production. In 1988 he joined Helvoet Pharma in Belgium where he headed the Helvoet Pharma R&D Centre. As per June 2004 he is heading the Helvoet Pharma Belgium Quality and Technical Support department.
Company Profile
Helvoet Pharma is the world’s second largest manufacturer of elastomeric closures and aluminium and aluminium/plastic caps for pharmaceutical applications.
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Abstract
The presentation discusses the following:
o
the need for
compatibility of rubber plungers with WFI called for low extractables /
low leachables materials. o irradiation sterilization emerged as sterilization method. Irradiation sterilization as opposed to steam sterilization imposes different requirements on the elastic behaviour of prefilled syringe plungers.
o the advantage of high viscosity silicone in the activation and gliding behaviour as well as in the particulate cleanliness of the prefilled syringe contents is illustrated.
o for needle sheaths and tip caps market requirements have led to the phase-out of natural rubber as elastomeric base material.
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