The company claims the single-use four-layered medical grade container is very clear, making it easier for production staff to see into the process container and monitor production. It also offers robust containment of the container's contents.
The use of disposable equipment in biologic drugs production is increasing, as the benefits of reduced contamination risks and time savings, mainly by eliminating the need for cleaning and sterilisation between batches, become clear.
As an example, an analysis of the the vaccine sector estimated recently that 70 per cent of development and production time is spent on quality and safety controls. The introduction of disposables will eliminate steps like cleaning, thus reducing cost and time spent on unnecessary steps.
The concept of PureFlex container film is that it will be a substitute for large volume containers. The film is either designed to a customer's specifications or come in a standard format. Millipore promises the film has been designed to show "exceptional clarity and gas barrier performance", "robustness" and "increased flexibility". Further advantages, it says, come from the product's "maximum resistance to flex-cracking, outstanding inert contact layer with low extractable levels and animal-free formulation."
Millipore anticipates the film will be used in a number of applications, such as in process intermediates, bulk storage, transportation of liquids under sterile conditions, cell culture, and buffer and media preparation.
PureFlex is a new addition to the Mobius brand of flexible bioprocessing solutions. On December 6-7, the disposable film will be introduced at the IBC Life Sciences Biopharmaceutical Manufacturing & Development Summit" in Orlando, Florida.