Sealing technology manual for the process industry - Pharmaceutical industry

The purity requirements with respect to processes and products in the phar- maceutical industry require sealing solutions that reliably prevent process contamination, beyond their respec- tive media resistance. Freudenberg has developed special materials and seals, such as white EPDM and Simriz® (FFKM), which comprehensively satisfy both the de- manding operating conditions and si- multaneously support the hygienic processes. In the pharmaceutical industry, the synthesis of products takes place from basic chemicals. The basic and reactive chemicals need to be extra pure so that no unwanted by-products are generated in the synthesis. In general, production is done in batches in order to ensure traceability from the raw Production of finished medicinal products During the production of chemically produced drugs API (Active Pharma- ceutical Ingredients) or in vivo diag- nostics (contrast agents, biomarkers), chemicals and toxic substances are used. During organic synthesis, high temperatures and high pressures oc- cur, whereas cooling takes place dur- ing the precipitation of the product. The temperature range is correspond- ingly quite large. To ensure the hy- giene and purity of a batch, special at- tention must be paid to the documen- tation of the processes. Thus, the ingredients of the sealing materials must be known too, or appropriate confirmation of biocompatibility ac- cording to USP Chapter 88 (Class VI) must be available. material supplier to the patient in the event of quality problems. Seals are a not to be underestimated part in this process because they partly have di- rect contact with the media. And with the appropriate sealing technology, the risk of contamination and thus of costly and time-consuming retracing can be reduced. A particular challenge for this industry lies in the versatility of its processes where many different demands are made on the components. To illustrate this, three areas and their peculiarities are presented in this context. THE PROCESS INDUSTRY AND ITS REQUIREMENTS PHARMACEUTICAL INDUSTRY Introduction 16

Pages Overview