René Fuhlendorff is a professional chemist with a background in organic analytical chemistry. René Fuhlendorff holds his degrees in organic chemistry and physics from the University of Aarhus, Denmark and from the University of East Anglia, Norwich, England.

In his 12 years of professional experience he has worked with analytical chemistry in former employment at the Danish Technological Institute and at the Laboratory division at the Danish Land Development Service (now a member of the MILJØ-KEMI Group).

He has a specialised experience in chromatography and mass spectrometry regarding analyses for a numbers of organic compounds in various solid matrices as materials (polyurethane, plastics, rubbers and polymers, consumer products and toys, food packaging, medico technical equipment and safety equipment, chemical products and various environmental samples (soil, sediment, sludge, ground water etc.).

René Fuhlendorff manages the Division for Advanced Laboratory Testing and R&D in MILJØ-KEMI, Danish Environmental Center A/S (member of Eurofins Scientific). His responsibilities include supervision of specialised analyses and testing, method development, validations, and customer relations. He is in charge of contract work and testing for national and international industrial clients and authorities.

The use of chemical tests for documentation of materials in medical applications is widespread.

As the tests are required from authorities there is a long tradition for standardized tests with very specific purposes. Due to this fact the answers to more transverse questions regarding product quality cannot always be found from these tests.

Tailored material tests are becoming more interesting whenever documentation is needed in the early stages of the product development, or whenever more complex product knowledge is needed. This can also be seen in related areas where plastic materials are used: In the foodstuffs industry; for food packaging, for plastic articles intended to contain foodstuffs, and even in the toy industry where high quality products are of increasing interest to the consumers and the authorities.

In qualification and quality control of packaging components for human drugs and biologics there is a correlation between the degrees of concern associated with the route of administration and the likelihood of packaging component – dosage form interaction: The higher the likelihood of packaging component – dosage form interaction the more comprehensive information is needed.

Suitability studies and quality control studies of materials for medical use requires various tests to describe and continuously prove the suitability for the intended use. Examples of such tailored tests are described.