Automated Vision Inspection for Elastomeric Components

Mike Schäfers

West Pharmaceutical Services Deutschland GmbH & Co. KG
Stolbergerstrasse 21-41, DE-52249 Eschweiler, Germany
Tel: +49 2403 796 154  Fax: +49 2403 796 303

Biography

Dr. Mike Schäfers is Vice President Marketing Europe at West Pharmaceutical Services and responsible for West´s Marketing and Technical Customer Service activities in Europe.

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 headed the Scientific & Technical Customer Service Group for the European and Asian-Pacific market, before he became in 2005 responsible for Marketing and Technical Customer Service at West.

He is member of the Parenteral Drug Association (PDA) and the ´Arbeitsgemeinschaft für pharmazeutische Verfahrenstechnik´ (APV) and a frequent speaker and organizer of conferences.

Abstract

Good pharmaceutical practise requires the individual physical inspection of containers in order to reject those showing evidence of contamination with visible foreign material. In addition, specific markets as i.e. Japan or market segments as i.e. high value biotech drugs are also sensitive about any cosmetical defect which negatively impacts the visual appearance of the drug product. Offering ready-to-use or ready-to-sterilize elastomeric components that are already visually inspected under ISO 5 (class 100) cleanroom conditions just before final packaging helps on one hand to improve the manufacturing process at pharmaceutical/ biopharmaceutical companies by optimizing throughput and reducing waste after filling but on the other hand also increases the quality level and quality perception of the final drug product. The session will make you familiar with innovative, automated visual inspection technologies for elastomeric components, the detection principle, the detectable contamination categories like particles, hairs/fibres and sizes as well as the necessary steps to detect e.g. cosmetic defects based on customer specific requirements. The visual inspection established as a documented, validated process helps to ensure consistency of elastomeric component preparation from clinical testing through commercialization and offers the advantage of 100% optical control even in areas of rubber components not accessible after drug filling.