The European Directorate for the Quality of Medicines & HealthCare (EDQM) in Strasbourg has again confirmed Sachtleben's leading status as a producer of high-purity barium sulfate for use in X-ray contrast agents. The new certificate now applies without any chronological limitation in practically all countries of the European Union and in those states that have pharmaceuticals produced and monitored in accordance with the European Pharmacopoeia. In addition, both the US pharmaceuticals-registration authority, the FDA, and the registration authorities of Canada, Australia, New Zealand, Tunisia and Morocco, also recognize this certificate. With this CEP (Certificate of suitability of Monographs of the European Pharmacopoeia) document, Sachtleben demonstrates to its partners its adherence to the very highest quality and purity standards, in accordance with the rules of European pharmaceuticals surveillance, in the production of its BLANC FIXE XR range, the primary ingredient in X-ray contrast agents.
Sachtleben's BLANC FIXE XR branded range of products makes the company one of the world's largest producers of active ingredients for X-ray contrast agents. This high-purity synthetic barium sulfate permits fast and easy X-ray examination of the gastrointestinal tract, for example, at rational cost. Incorporated into surgical instruments, medical sutures and catheters, BLANC FIXE XR makes the corresponding examinations and operations visible on the X-ray screen. Even small plastic toy parts which could be swallowed by children are impregnated with BLANC FIXE XR to make them easier to detect in emergencies.
No loss of know-how thanks to CEP
As a producer of active ingredients, Sachtleben is obliged to document its production route and registration of BLANC FIXE XR for subsequent use in the pharmaceutical and/or medical sector. This documentation is effected by means of the CEP certificate and is deposited with the EDQM in Strasbourg. It is subdivided into a "General" section, which describes the analytical methods applied, the transportation containers used and their materials, the chemicals used and, of course, detailed information on the active ingredient itself, and a "Non-public section", in which the product process, methods, plus the feed materials and their suppliers are recorded. Only the important chemical, pharmacological and pharmaceutical data and substance properties are accessible to pharmaceuticals producers via the general section of the CEP. This assures for the substance producer - in this case, Sachtleben - that there will be no loss of know-how as a result of disclosure of all production operations.
The EDQM, Europe's supreme pharmaceuticals control authority, thus makes a great contribution to preventative health care. It also facilitates free trade in goods between the member states, since the regulatory instruments and methods of the European Pharmacopoeia Convention (Ph. Eur.) are recognized and acclaimed well beyond the bounds of the European Economic Region.
