We supply products of the highest safety and proven suitability for use – this standard is guaranteed by the quality management (QM) system implemented at B+K. The quality management system ensures the process capability and the quality of our products on the basis of all relevant legal regulations and standards. Back in 1990, B+K became one of the first companies within the packaging industry to obligate itself to the concept of quality, establishing and certifying its QM system according to the DIN EN ISO 9000 ff series of standards. Since then, we have complied with all revisions to the standards and are now certified according to DIN EN ISO 9001.
In internal laboratories, the quality assurance department checks the specified quality of the products. The quality assurance department additionally controls and monitors in-house
production checks and advises in all matters of relevance to quality. Technically complex tests are processed within the central Bischof + Klein laboratory. The regulatory affairs department is available in the event of questions pertaining to legal requirements and declarations of conformity, particularly with regard to foodstuffs and other commodities.
Quality assurance for such sensitive products necessitates particular care and special control mechanisms. The safety of all products, particularly high-purity products (brand name CleanFlex®), is guaranteed by conscientiously validating all quality-relevant processes and monitoring production and production conditions. This also includes regular particulate and biological monitoring to ensure purity in the production areas, particularly the clean room production facility.
Our integrated hygiene management system guarantees that materials which come into contact with foodstuffs are manufactured under flawless hygiene conditions. This system has been developed on the basis of the Codex Alimentarius, the hygiene ordinance and the DIN EN 15593:2008 standard. In addition to documentation in the QM handbook, it also contains a hygiene risk analysis (HACCP analysis), which describes the handling of critical steering points. The Konzell factory is certified on the basis of DIN EN 15593:2008.
Food Safety Management
Our food safety management system guarantees adherence to commodity legislation, i.e. all legal regulations based on framework directive 1935/2004/EC, particularly those concerning the possible transition of substances contained in packaging to a foodstuff. The exclusive use of approved raw materials and further organisational measures ensure that any risk to the health of consumers due to substance transition is out of the question. This management system has been developed on the basis of the DIN EN ISO 22.000 standard "Food Safety – Requirements on Organisations in the Food Chain". In addition, the majority of the raw materials which we use forfoodstuff contact materials comply with the corresponding FDA regulations.
GMP stands for "Good Manufacturing Practice". The legislator takes this to refer to the care required in manufacturing products using quality management and quality assurance. At B+K, GMP management is also contained in the QM documentation as an integral part of the quality management system. For materials which come into contact with foodstuffs, the GMP system is based on GMP ordinance 2023/2006/EC
and on the DIN ISO 15378 standard for primary pharmaceutical packaging. At B+K, packaging for pharmaceuticals, medical technology products and other high-purity products is manufactured under clean room conditions and marketed under the CleanFlex® brand name.
Dr. Kai Dormann
phone +49 5481 920-394
fax +49 5481 920-98394
Hygiene Certificate DIN 15593
State: 05.12.2014 (86 Kb)
DIN ISO 15378:2011 Primary Packaging Materials for Medicinal Products
State: 03.12.2014 (84 Kb)
DIN EN ISO 9001:2008 English
State: 24.11.2014 (731 Kb)