New state-of-art Competence Centre for metals testing in pharmaceuticals and biopharmaceuticals established in Copenhagen

By Hanne Kyhnau Hansen and Jacob Jacobsen, Eurofins Pharma Product Testing, Denmark

Eurofins Pharmaceutical Products Testing has established a new state-of-the-art testing facility in Copenhagen for the testing of trace metals in pharmaceuticals, clinical and preclinical samples.

The site is equipped with ICP MS and ICP OES equipment and with Part 11 compliant software and qualified according to European and US guidelines. A special high pressure room has been established to enable detection down to ppt level, especially relevant for microscale (10 mg) analysis of tissue samples for trace metals.

Eurofins Pharma is regularly audited by FDA, European authorities and major global pharmaceutical companies and has established a strong audit track record. The Metals Team is headed by Hanne Kyhnau Hansen, with more than 15 years analytical metal testing experience, a team of senior chemists and very experienced metals analysis lab technicians. The team develops and validates analytical methods for the routine analysis of samples with critical importance for the pharmaceutical industry and routinely conducts release testing for pharmaceutical clients.

The Eurofins Pharma Products Testing Group has invested significant resources in high pressure facilities, specialised equipment for pre-treatment and analysis of samples, training of specialists, complete qualification of equipment and software in line with the Eurofins philosophy to create Centres of Excellence for highly specialised analytical purposes.

This Centre of Excellence is designed to meet the increasing demand from regulatory authorities in Europe, US and Asia for the quantification of metal impurities in pharmaceuticals in order to protect human health. The increasing quantification requirements are exemplified by the upcoming USP <232> and <233> and EP counterparts, recently introduced by US and European Pharmacopoeias.

The Metals Competence Centre in Copenhagen has been set up in close collaboration with the Metals Competence Lab located at the Eurofins Lancaster Laboratories site in the US. Both sites use the same metals testing equipment and approaches in order to facilitate a global analytical service offering for the pharmaceutical industry.

For further information, please contact:
Europe: pharma@eurofins.dk
USA:  GMP_US@eurofins.com