Stopper Selection For Freeze Drying Applications

 

Mike Schaefers

 

West Pharmaceutical Services Deutschland GmbH & Co. KG

Stolbergerstrasse 21-41, DE-52249 Eschweiler, Germany
Tel: +49 2403 796 154  Fax: +49-2403-796-303

E-mail: Mike.Schaefers@westpharma.com        

 

  

Biography

 

Dr. Mike Schäfers is Director Marketing Europe at West Pharmaceutical Services.

 

He studied chemistry and business management and received his PhD from the Ruhr University in Bochum, Germany in 1996. After 4 years of business experience at the drug delivery company R. P. Scherer GmbH & Co. KG in Eberbach, Germany he joined West Pharmaceutical Services in 2000 where he started as Director Scientific & Technical Customer Service Europe/  Asia-Pacific. Since 2005 he is Director Marketing Europe and responsible for West´s Marketing and Technical Support activities in Europe.

 

He is member of the Parenteral Drug Association (PDA) and the ´Arbeitsgemeinschaft für pharmazeutische Verfahrenstechnik´ (APV).

 

 

 

 

Abstract

 

Unique Packaging Solutions for Prefillable Syringe Systems

 

This discussion will address the current trend to apply unique coatings to syringe plungers, tip caps and needle shields to minimize elastomeric interactions and improve extraction and leachable profiles.

 

The presentation discusses the need to minimize or eliminate protein aggregation due to silicone oil interaction and reduce drug product adsorption on the barrels. It includes a review of fluorocarbon film coated plungers and tip caps in biopharmaceutical applications, as well as recent developments on a full faced film coated plunger which negates the use to silicone as a lubricant.

 

The presentation covers practical issues from industry with proposed solutions.