25 June 2012
Merck Animal Health Facility Among the First Sites Certified According to New Standard CWA 15793:2008 on Laboratory Biorisk Management
COLOGNE (Germany), June 25, 2012 – The Merck Animal Health (known as MSD Animal Health outside the United States and Canada) foot-and-mouth disease (FMD) research and vaccine manufacturing site in Cologne (Germany) is among the first facilities worldwide that have been certified according to the new standard CWA 15793:2008 on Laboratory Biorisk Management. This new standard sets requirements for the control of risks associated with working with biological agents and toxins in laboratories and facilities.
Upon initiative of the local management, the facility has been audited in March 2012 by the German Social Accident Insurance Institution for the Raw Materials and Chemical Industry (BG RCI), an industrial institution for statutory accident insurance and prevention. The official certificate declares that the site meets the requirements of systematic and effective occupational safety and health on the basis of the “Systematic Safety” seal of approval for the industry-specific implementation of ILO-OHS 2001 (guidelines on occupational safety and health management systems of the International Labour Organization). The assessment also proved that the CWA 15793:2008 guidelines are implemented. The official documentation was presented on June 21 at a formal ceremony to Dr. Klaus Kriebitzsch, site director of the Cologne facility.
“At Merck Animal Health, raising biosafety standards and adherence to the applicable guidelines are top priorities. Therefore, we are extremely proud that our FMD facility here in Cologne is among the first in the world certified according to this biosafety standard that is likely to become a new norm in the international biosafety community”, said Dr. Tobias Schlapp, head of Regional Animal Health Bio-Manufacturing at Merck Animal Health.
Standard CWA 15793:2008, which is voluntary to companies, has been developed by the European Committee on Standardization (CEN) following discussions with biosafety and biosecurity experts from around the globe, including representatives of the European and American Biological Safety Associations (EBSA and ABSA, respectively), the Asia-Pacific Biological Safety Association, the World Health Organization (WHO) and Det Norske Veritas (DNV).
The Cologne FMD site is Merck Animal Health’s international competence center for emerging diseases. The EU-approved site researches, develops and produces vaccines against FMD. The facilities for antigen production, research and quality control are located in an area that is isolated from the environment (high containment, BSL3). The site also hosts antigen banks for several countries which can guarantee the emergency supply of FMD vaccines.