Quality Management

DIN ISO 9001

Viscofan BioEngineering is certified according to DIN ISO 9001:2008. Therefore, all processes and especially the production and quality assurance processes are reliably defined, controlled and described in a quality management system. With this system, a detection of the possible errors, their causes and a consequent revision is guaranteed. Thus, the DIN ISO 9001 is one important component to achieve our quality objectives.

 

 

 

 

Safety

For our collagen products bovine skin is used, which has been classified by the World Health Organization (WHO) as a category 4 tissue with no detectable infectivity. Thus, the skin has been assigned to the lowest category and at the same level as milk. This assessment is also shared by the World Organisation for Animal Health (OIE). Additionally, our raw material is in compliance with the norm DIN EN ISO 22442 “medical devices utilizing animal tissues and their derivatives”. According to this, we source our collagen from animals with full traceability and in all processes we strictly keep the raw material separated to minimize the risk of cross-contamination.

Biocompatibility

The monitoring of our industrial purification, filtration and production processes ensures the production of ultrapure biocompatible collagen products, consisting of collagen type I. We routinely assess the quality of our products in chemical, physical and biological assays. Microbiological testing, in particular determination of endotoxin levels, is routinely performed for our products. Different tests from cooperation partners have demostrated the excellent suitability of our products for applications in the fields of cell culture, basic research in tissue engineering and regenerative medicine. In several in-vivo implantation studies the high biocompatibility of our collagen procuts has been proved in animal experiments.

Cell cultivation

Our Collagen products are excellently suited for cell culture applications. The compliance with our product specifications is controlled in our quality control system by regular measurement of parameters like DNA- and RNA-concentration and Endotoxin levels. As the final quality test, cells are cultivated on our products and their morphology, proliferation and viability are assessed.