High Market Requirements and their Impact on the Manufacturing of Elastomeric Closures

Renaud Janssen

Helvoet Pharma

Industrieterrein Kolmen 1519, BE-3570 Alken, Belgium

Tel: +3211 590878   Fax: +3211 590923
Email: renaud.janssen@helvoetpharma.be

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 until 2004 he headed the Helvoet Pharma R&D Centre. Currently Renaud is leading Helvoet Pharma’s Global Technical Support group.

Company Profile

Helvoet Pharma is the world’s second largest manufacturer of elastomeric closures and aluminium and aluminium/plastic caps for pharmaceutical, medical and diagnostic applications.

Abstract

Primarily driven by the sensitivity of the Japanese market for the cosmetic quality of elastomeric products and for the absence of contamination of any kind, both particulate and biocontamination, requirements in this field of the entire world market have grown tremendously in the last decade.

For elastomeric closure manufacturers this poses a considerable challenge. It urges them to raise the bar in several fields. Manufacturing processes must be subjected to a risk analysis with the aim to isolate critical points where contamination can come in. Subsequently these points need to be worked on both in a preventative and next, as an extra level of security, in a corrective way.

Preventive measures a.o. lead to manufacturing in clean areas, controlling these areas to tighter limits, systematically keeping products away from potential environmental contamination, strict limitations on exposure of products to men during the manufacturing process, consequent application of cGMP rules including in-depth training of all personnel, also outside of the manufacturing area, and adaptation of Quality Systems.

Corrective measures a.o. entail the development and implementation of improved final washing processes and of advanced camera inspection systems for detection of cosmetically contaminated products.