How to Integrate Compendial Testing into the Quality Control of Medical Plastics

Frank De Smedt

Toxikon Europe NV
Romeinsestraat 12, BE-3001 Leuven, Belgium
Tel: +32 16 400484   Fax: +32 16 401304
Email: frank.de.smedt@toxikon.be

Biography

Frank De Smedt received his Ph.D. in Science (Physical and Analytical Chemistry) in 2000 from the Catholic University Leuven, Belgium. He is experienced in the field of analytical and environmental chemistry. After seven years of postdoctoral research at the University of Leuven during which he was involved in various European research projects, he started at Toxikon Europe as study director, responsible for the validation of the analytical methods for extractables and leachables studies.

Company Profile

Toxikon Corporation, headquartered in Bedford (USA), is a life science company and a Contract Research Organization (CRO) that primarily conducts compliance studies for product safety. The European laboratories are located in Leuven (Belgium). They operate a brand new state-of-the-art facility.

With 30 years of industry experience, Toxikon conducts compliance safety testing and research following Good Laboratory Practices (GLP) and according to the most recent guidelines and standards. Additional to the total package of services including safety studies, lot release testing, microbiology and in vitro toxicological procedures, Toxikon Europe is focusing on Extractables and Leachables testing.

Abstract

This presentation will illustrate the use of compendial testing in the pre-market and in the post-market phase of a medicinal product. Recently the use of compendial testing in the quality control of e.g. medical plastics is getting more attention.
In a first part the regulatory aspects for plastic materials intended to be used for the packaging of active substances and medicinal products are summarized, more particularly the corresponding FDA and EMEA-guidelines.

The latter guideline will be discussed in more detail, e.g. the decision tree for the plastic packaging material for the active substance and the drug product. An important item within this guideline are the tests for packaging materials which are described in the European Pharmacopeia, e.g. PVC, EP, silicone, … One compendial test will be elaborated, more specifically E.P. 3.1.5 for Polyethylene with additives.

Finally some conclusions concerning the use of compendial testing in quality control will be made.