Life science products like pharmaceuticals, biologics and biosimilars that feature active pharmaceutical ingredients (APIs) require the safe, efficient, contamination-free, i.e., “aseptic,” handling of raw materials and finished products. Maintaining a sterile production process demands that all components used in a cleanroom or isolator be kept contaminant-free. Beta bags play a critical role in this process, but before selecting a beta bag brand or model, the aseptic-process operator should consider four things:
1. What is the main purpose of beta bags?
Alpha ports (sealed openings) used in cleanrooms and isolators give operators access to various components during an aseptic-production process, allowing the operator to retrieve items ranging from vial stoppers to syringe plungers, hand wipes to cable ties, and simple pen and paper. Contamination-free access is created by using a beta bag docked to the alpha port via a flange on the isolator’s alpha port, with newer beta bag designs compatible with different models or styles of alpha ports.
2. How do single-use beta bags improve aseptic-processing operations compared to traditional procedures?
Single-use beta bag systems reduce the downtime and cost needed to clean and revalidate a multi-use system. Fully sterilized beta bags will facilitate the leak-free transfer of sterile components into isolation and the removal of toxic components or waste. Beta bags are constructed of sheets of Tyvek — a high-density, tear-resistant polyethylene fiber — and a high-density polyethylene (HDPE) plastic. These two sheets are welded together to form a strong, tear-free bond that helps ensure leak-free operation. Additionally, the beta bags are welded to an HDPE weld ring mated to a polycarbonate flange that docks to the isolator’s alpha port to complete the beta bag system.
3. What is the typical size and capacity of a beta bag?
Beta bags sizes are delineated by a measurement in millimeters. The delineation is based on the approximate maximum width of an object that can fit through an open alpha port, though the maximum cylinder diameter of the object is generally 15–20 mm (0.6-0.8 inches) smaller than the model size. So, a typical beta bag size is 190 mm, or 7.5 inches, meaning it’s compatible with an alpha port that can accommodate an object from 170 to 175 mm (6.7-6.9 inches) in width. In terms of capacity, a 190-mm beta bag can hold volumes of up to 25 liters (6.6 gallons).
4. Can your supplier deliver single-use beta bags on time?
Beta bags are useless if they are sitting in a supply warehouse, on a loading dock or the bed of an idled delivery truck. Realizing on-time delivery, however, can be problematic when dealing with large beta bag manufacturers that can have delivery lead times as long as 30–50 weeks. Also, in some instances, operators may be asked to purchase beta bags in “one size fits all” or “inconvenient” quantities that are not in tune with their specific needs. New customers may also not be able to get a timely supply as existing customers get priority.
Jim Peterson is a sales manager for Central Research Laboratories (CRL) based in Red Wing, Minnesota. He can be reached at [email protected] More information is available at https://crlsolutions.com/single-use-beta-bags.