Beta Assemblies are lesser known but indispensable components in maintaining aseptic and sterile environments during pharmaceutical manufacturing. Betas are the variety of bags, containers, flanges, and other assemblies used to transport virtually everything into and out of sterile environments. Used in conjunction with the Alpha port installed on isolators and RABs, the unheralded Betas shoulder the workload of getting essential components into (or out of) production processes.
Alpha ports and their associated Betas make up the Transfer System. One of the reasons for the popularity of Alpha/Beta Transfer Systems in the pharmaceutical manufacturing process is how well the process for maintaining sterility works. A special tool opens the Beta assembly, allowing it to be filled. Next, through whatever process the user has established, the components inside the Beta are sterilized. Finally, the sterile parts are then moved from the Beta to the fill line. Critically, the mated assembly cannot be opened until it is securely docked to the Alpha port; ensuring a sterile transfer of product into the manufacturing process without breaching containment.
Another reason that RTPs are so common is the diversity and versatility of Beta assemblies. Below is a description of the most common choices and some of the advantages of their use.
Reusable canisters, made of plastic or metal, can be used over and over to transport hazardous or radioactive materials. Canisters are ideal for aseptic components that don’t necessarily need to be sterilized or for removing waste from containment.
Specially designed autoclave canisters include venting and filters required for steam sterilization. Unlike bags, these canisters can be autoclaved multiple times. Autoclavable canisters are ideal for complex components or testing equipment that must be cleaned between uses.
Single-Use Beta Bags
Beta Bags are popular in single-use applications with high volumes such as stoppers and vials. They are significantly lighter and less expensive than canisters and designed to be discarded after one use. Beta Bags come in a variety of sizes and volumes with designs intended for both autoclave gamma irradiation.
Sterile Liquid Transfer
These specially designed Beta assemblies are used for liquid transfer. This allows tubing and other necessary components to be sterilized and then fed into the isolator. While the Beta assembly might be reused multiple times, the tubing and other components can be single-use.
Some customers prefer a simple, reusable Beta flange that can be paired with single-use bags attached with a clamp. These bags are popular for waste and sample removal as they are less expensive than single-use bag assemblies.
Due to the variety of applications and assembly options, it can be daunting to determine which Beta choice is right for you. Central Research Laboratories has a full range of customizable RTPs, Beta assemblies, and a team of material handling experts ready to assist with your application needs. Contact us for more information on any of these assemblies, or product recommendations for specific applications.