Pharmaceutical manufacturers are increasingly interested in biologically derived drug products. Many biopharmaceuticals are administered as injections, and sterility is of paramount importance for parenteral delivery. This month's featured products are appropriate for biopharmaceutical production processes that require sterility. The first is a filter that removes bacterial contaminants and can be used in biopharmaceutical fill–finish applications. The second is an automated, aseptic filling system for injectables that can accommodate a disposable fluid path. This month's third product is a series of platinum-cured stoppers that withstand gamma irradiation and various chemicals, thus facilitating sterilization.
Filling system accepts various vial sizes
Lambert adds that the FPC50 unit features Watson-Marlow's peristaltic dispensing pump. The peristaltic pump allows the use of disposable fluid paths, which simplify the cleaning validation of injectable filling.
The FPC50 system is designed to enable tool-free format changeovers.
Filter withstands gamma-sterilization
The Steridyne 50 unit can be easily incorporated into single-use biocontainer assemblies as a sterile vent filter. The product is also designed for in line filtration of air or gases and as a sterile barrier in receiving vessels, culture vessels, bioreactors, fermentation tanks, transfer vessels, carboys, and other small containers.
Stoppers meet regulatory standards
The platinum-cured silicone units offer higher purity and longer life expectancy than components made from other materials, according to the company. Unlike rubber products, the closures withstand temperatures from –100 to 400 °F and resist cracking and various chemicals. In addition, users can sterilize the components by autoclave or gamma radiation. The products are appropriate for reuse and single-use applications.
The biologically safe products are designed to ensure aseptic fluid transfer, sealing, filling, and sampling.
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