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 United States Food and Drug Administration and the United States
Pharmacopoeia now characterize 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.
Posted by Dr. Tim Sandle
