The latest improvements in aseptic blow/fill/seal technology are streamlining automation of critical processing areas, while limiting human intervention and effectively reducing particulate levels. Chuck Reed, Weiler Engineering, describes the implications for enhancing sterility assurance and patient safety.
Aseptic blow/fill/seal (B/F/S) systems for the processing of pharmaceutical liquids have experienced rapid and growing acceptance by the pharmaceutical industry over the past 20 years. This has been accelerated by enhancements made to aseptic B/F/S processes based on pharmaceutical industry input and to accommodate the requirements of regulatory agencies.
These enhancements were designed to improve product integrity and help ensure patient safety. As a result, the US FDA and the US Pharmacopoeia now characterise modern B/F/S technology as an ‘advanced aseptic process’, indicating its use as a preferred technology over other aseptic systems and a better solution for the sterile, aseptic processing of pharmaceutical liquids.
Aseptic B/F/S systems offer a unique combination of flexibility in packaging design, low operating cost and a high degree of sterility assurance. Due to its design and functionality, B/F/S processing inherently produces very low levels of particulate matter, and much of the potential for microbial contamination in its critical areas is mitigated by the absence of human intervention in these areas.
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