Ensuring product is free from contamination is critical in any aseptic manufacturing process. Whether working with sterile API formulation and production or sterile fluid transfer and aseptic filling – in pharmaceutical manufacturing processes, sterility must be maintained at every step to ensure the final product is contaminant-free.
Therefore, in a single-use process environment, how do we transfer components into or out of controlled environments, without compromising the sterility?
Single-Use Beta Bags offer the solution
Single-Use Beta Bags are the vital link in the aseptic manufacturing chain, constructed of high-grade plastics that are autoclavable or gamma-sterilisable, together with a flange that directly connects to an Alpha port on the isolator. The Beta Bag system then allows for sterilised components to be transferred into the production process, with no risk of contamination to the components and maintaining sterility of the environment.
How is it made?
Manufactured using a combination of Tyvek® and a high-density polyethylene (HDPE) plastic, which are welded together to form a strong bond in this single-layer bag. A HDPE weld ring is then welded to the bag which is permanently connected to a polycarbonate flange, to complete the beta bag system. When combined with an Alpha Port, this polycarbonate flange is what mates the entire bag assembly to the Alpha port on an isolator – Ensuring sterility from beginning to end.
Are Beta Bags suitable for my application?
Single-Use Beta Bags are a safe, efficient, and cost-effective solution, produced specifically for life science applications. Providing a simple and reliable way of transferring components such as stoppers, connectors, bottles or caps into a controlled environment, the beta bags can be supplied pre-filled or filled on site.
In liquid transfer applications, beta bags can be manufactured as a full tube set assembly complete with filling needles, ports, connectors and bioprocessing bags to your specification, making them ideal for final fill applications.
How do you attach a Beta Bag to an Alpha Port?
Connecting a beta bag to the port is made simpler with the reusable, removable handle system.
At BioPharma Dynamics, together with our supply partner CRL, we can offer a complete solution with the isolator port and single-use beta bag assemblies that suit your process. Working to your specifications, we can supply Single-Use Beta Bags that are pre-filled with the components you need and fully gamma irradiated, to guarantee complete sterility.
Providing complete flexibility in your process, CRL’s Single-Use Beta Bag flange is compatible with other Alpha port designs, working seamlessly with your current solutions for even greater production flexibility. Both autoclavable and gamma-sterilisable versions of the Single-Use Beta Bags are available.
Contact us today to discuss your processes.
01235 750 690