EMPLOYING QBD TO MITIGATE RISK IN ASEPTIC PARENTERAL FILL AND FINISH

摘要

It will probably come as something of a surprise to European biopharmaceutical manufacturers that few injectable drug products are packaged using blow/fill/seal (BFS) technology in the US. This advanced aseptic process has been used for decades to provide sterile products in the ophthalmic and respiratory markets and is extremely well understood in those sectors. Additionally, it is commonly employed by pharma companies in Europe, Asia and South America for injectables. Yet in the US, despite its many benefits over traditional aseptic filling techniques, it has thus far had limited use in the injectables market.