Sealing technology manual for the process industry

In galenics (pharmaceutical technol- ogy), the medicinal product receives its form. For example in this step a tablet is pressed and coated so that the medication can be taken. Before a tablet can be pressed, the active ingre- dients and excipients must be manu- factured according to the recipe, wet granulated, and then dried and ground. For seals, this means that they have to exist in a “dusty” environ- ment. In addition, no components of the seal that could negatively alter the pharmaceutical product in its compo- sition or color must be allowed to mi- grate into the production process. The seal must also protect the pharmaceu- tical product against external influ- ences in the sterile environment. Product formulation by blood frac- tionation In the separation of blood, the various blood constituents are separated by centrifugation. For fractionation, pro- teins are separated from blood plasma with the admixture of ethanol at –3 °C to –6 °C (+27 °F to +21 °F). The plasma is cooled to –30 °C (–22 °F) very quickly. Not every seal withstands this enormous jump in temperature. To avoid contamination, seals for this area must also be designed free of dead space and be resistant to CIP and SIP cleaning processes and cleaning media. Furthermore, defined emission limits must not be exceeded. Freuden- berg offers special sealing materials for these aseptic high-purity processes in the pharmaceutical industry which are resistant to low temperatures and chemicals. Biopharmaceuticals Strict hygiene regulations prevail in the production of vaccines, enzymes or proteins which also apply to all other process components, such as seals. With respect to separation of the active ingredients, purity has top priority, which requires seals without dead space that provide no basis for germs. As in any hygienic area, clean- ing is carried out with aggressive me- dia using the CIP/SIP method in order to clean the plant free of residues. When mixing the ingredients, cooling is required which involves cold- resistant sealing materials. It is also important to protect the pharmaceu- tical product during filling in order to prevent process contamination. APPENDIX PRODUCT PORTFOLIO MATERIALS RESISTANCE & PURITY ENGINEERING PLASTICS ELASTOMERIC MATERIALS TECHNICAL FUNDAMENTALS INTRODUCTION 17

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