Advances In Aseptic Blow-Fill-Seal Processing: Improve Product Integrity 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 United States Food and Drug Administration and the United States armacopoeia 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.
Microbial contamination is a serious issue for companies manufacturing liquid pharmaceutical formulations. Such liquids are ideal growth areas for bacteria like Salmonella, Escherichia coli and Staphylococcus microbes that have been found in various liquid drug products. A supposedly sterile, but contaminated product may result in deterioration of the drug and loss of potency, and with parenterals can cause pyrogenic reactions after administration to patients. The majority of liquid drug product contamination over the past several decades has come about from products produced in conventional (non-B/F/S) aseptic processing facilities. In conventional aseptic processing, the drug product, container and closure are subjected to sterilization processes separately, and then brought together. There is no further processing to sterilize the product after it is in its final container, therefore it is critical that containers be filled and sealed in an extremely high-quality environment.
Aseptic B/F/S technology integrates blow molding, sterile filling and hermetic sealing in one continuous operation to produce aseptically manufactured pharmaceutical liquid products. Unique to aseptic B/F/S systems compared to traditional aseptic processing, is its capability for rapid container closure and minimized aseptic interventions.