How many dockings can a beta bag take? For the DELTAQUANT 190 mm single-use beta bag the published figure is up to 5 dockings per bag. That line sits on the spec card of the products page as "Multi-connect · Up to 5 dockings", and it is the only docking figure DeltaQuant Lifesciences FZE publishes. This article explains where it comes from, what it covers and how to plan around it.
The short answer
Up to 5 dockings. The bag is single-use in the sense that it is not re-sterilised and reused; within one use it can be docked to an alpha port, undocked and docked again, up to five times. The rating is a ceiling, not a target. A typical transfer docks once, transfers and undocks. The multi-connect rating is there for the processes that need the same bag at the port more than once.
What happens at the flange on every docking
The bag is a flat pouch with the flange sandwiched into its face. The rigid 190 mm beta flange, with its flat cover, sits between the clear film face and the white porous barrier face; pouch material extends above, below and to both sides of it. On a docking:
- The pouch is brought to the port flange-first, flat and parallel to the isolator wall.
- The flange engages the alpha port and the bag turns a short way to lock. The alpha door and the beta cover become one plate.
- From inside the isolator the joined door swings inward. Contents pass through the open port into or out of the pouch.
- The door closes, the bag turns back and comes away with its cover re-sealed.
Two parts do the sealing work: the beta seal, in platinum-cured LIM silicone, and the O-ring, in platinum-cured silicone. Each docking compresses and releases them. The cover is removed and replaced from inside the isolator each time; its removal force has an acceptance criterion of 30 N or less, by an in-house method. Five dockings means five cycles of lock, open, close and unlock on the same seal and the same cover, with the boundary intact throughout.
How the rating is verified
Two lines on the verification bench carry the rating:
- Alpha-port docking. In-house method. Acceptance criterion: no barrier loss.
- Multi-cycle docking. In-house method. Acceptance criterion: up to 5 dockings.
Both are read against the microbial barrier itself, which is tested to ASTM F1608 with an acceptance criterion of LRV 4 or more. In other words, the question the multi-cycle test asks is not whether the flange still turns after five dockings but whether the bag is still a barrier after five dockings. The bench publishes the method and the acceptance criterion for every test. The measured value for a batch appears when its batch report carries it; until then the bench says "awaiting batch report", and this article says the same.
What the rating does not say
It gives no figure beyond five. The documentation set covers the method and the acceptance criterion; the measured result for your batch comes with the batch report. Nobody at DeltaQuant quotes a figure beyond the rating, and no page on this site does.
It gives no hold time between dockings. The product data states storage conditions for the bag as supplied, 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat, and nothing about how long a bag may wait between dockings inside a process. That interval belongs to your process risk assessment. If you need a view on it, ask engineering with the process details.
It is not a re-sterilisation. An indA bag is autoclaved once, before its first docking; one cycle only is part of the validated use. An indB bag arrives gamma sterile and is not re-sterilised. Docking again means the same sterile bag returns to the port, not a bag that has been processed again.
It assumes the right flange for the port. The rating is for a flange that locks correctly. For chamfered alpha ports the Interlock-chamfer (IC) version is the correct flange; for standard 190 mm alpha ports, the Standard version. The configurator shows both, with a close-up of the flange edge. A flange that does not match its port is a fit question, not a docking-count question, and it is answered before the first docking.
Planning transfers against the rating
- Count dockings per bag in the batch record. Give each bag a line and tick each docking. The lot is on the carton and the bag is overwrapped and tamper-evident sealed, so the count stays with the bag.
- A transfer in and a transfer out, with the bag off the port in between, is two dockings. Tools that go into the isolator in a bag and come out in the same bag use two of the five.
- Size the pouch for the whole campaign. If the bag will dock more than once, choose the volume that holds everything the campaign needs. 10 L and 25 L are the two standard sizes; custom sizes go through engineering review.
- Use the Pre-loaded line where the count would otherwise climb. If the reason for repeated dockings is bringing components in batches, a Pre-loaded beta bag loaded in DeltaQuant's ISO Class 7 cleanroom brings them in one docking. Units per bag are agreed per kit.
- Keep the standard and the IC version apart in stores. Both are 190 mm flanges; only one of them is right for a given alpha port.
In practice
Environmental monitoring is one case where a bag docks more than once: sampling tools and monitoring equipment go into the isolator and come out again, so the same bag docks more than once in a session. See beta bags for environmental monitoring and sampling, recommended as Empty · indB · 10 L. Aseptic waste removal, where the bag is docked, filled from inside and undocked, is the single-docking case at the other end of the range: see beta bags for aseptic waste removal. To check the fit and the rating on your own port, request samples; sales replies within one business day.