POLYMER PRODUCER'S APPROACH TO MEET WITH THE NEW TESTING REQUIREMENTS OF PHARMACEUTICAL PACKAGING AND DEVICE INDUSTRY

摘要

The examination of extractables and leachables is an area that is fast growing in importance. As a raw material supplier for the Healthcare industry Borealis wants to extend the current focus on product quality, pharmacopoeia and other regulatory compliances to meet also with the new demand. Borealis has started an extractables study for the Bormed product range to get extensive extraction profiles for the materials and to analyze the sources of identified components. Borealis' target is to help our customers and partners in the healthcare industry with their material selection process by giving indications on the possible leachables they could find in the finished products. Collected data can also be used to further enhance Borealis' quality procedures.