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.
BFS technology provides a significant advantage by drastically reducing the risk of microbial and particulate contamination. BFS is classified as an ‘advanced aseptic’ technique and meets the demands of the FDA’s 2004 cGMP guidance, ‘Sterile drug products produced by aseptic processing’, in terms of equipment, controls and microbial challenge test results. The process has no direct interventions made by operators and there are no open product containers or exposed product outside of the controlled class A space within the machine. Finally, the time and exposure in the class A environment is only seconds. This technology is fast, automated, and operates in a robustly controlled environment, with all parameters machine set and remotely monitored.
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