Beta bags for aseptic fill-finish carry what the filling isolator needs across the sterile boundary: product containers, closures, format parts, tools and sampling material. The DELTAQUANT 190 mm single-use beta bag from DeltaQuant Lifesciences FZE is a flat pouch with a rigid beta flange sandwiched into its face. It docks to the alpha port in the isolator wall, the port opens, the contents pass through, and the enclosure is never opened to the room. This page sets out the transfer problem on a filling line, how the bag solves it, and which line, variety and volume fit the use.
The use case: a filling isolator that stays closed
An aseptic fill-finish line runs inside an isolator or a closed RABS. The filling zone is Grade A. Everything that reaches it must be sterile on arrival and must enter without a door being opened. Once the isolator has been decontaminated and the campaign has started, every opening is an intervention: it has to be justified, recorded and, in the worst case, followed by a new decontamination cycle. EU GMP Annex 1 expects a contamination control strategy that keeps such interventions to a minimum and keeps the barrier closed while product is exposed.
The items that cross the boundary during a campaign are many and small. Stoppers for a changeover. A replacement filling needle or a format part. Sampling containers and environmental monitoring material going in; filled samples, used plates and waste coming out. A pass-box with its own decontamination cycle handles some of this, but each cycle costs time and stops the line. What the line needs is a closed transfer that can be repeated during the campaign, in minutes, with the same outcome every time.
How beta bags for aseptic fill-finish solve the transfer
The single-use beta bag is the beta half of an alpha-beta rapid transfer port. The alpha port is mounted in the isolator wall and keeps its own door. The bag brings a sealed cover of its own. When the two are locked together, the alpha door and the beta cover join into one plate, and the faces that were exposed to the room are held against each other while the plate swings inward. The inside of the isolator meets only the inside of the bag.
The DELTAQUANT beta flange is Ø 190 ± 0.4 mm, compatible with industry-standard 190 mm alpha ports. It is made in a Standard version for standard alpha ports and an Interlock-chamfer (IC) version for chamfered alpha ports; tell us the alpha port model and engineering confirms the fit before samples ship. The bag is supplied in a double-bag configuration, overwrapped and tamper-evident sealed, so the outer layer can be removed on the way into the classified area and the bag itself arrives clean at the port. One bag is rated for up to 5 dockings; the multi-cycle docking test is an in-house method with no barrier loss as the acceptance criterion, so a bag can go to the port more than once within a campaign.
How a transfer runs
The operator brings the pouch to the port flange-face forward, flat and parallel to the isolator wall. The flange bayonets engage the alpha port and the bag is turned a short way to lock; the alpha door and the beta cover are now one plate. From inside the isolator, the gloved operator swings the joined door inward and takes the contents out of the pouch, or places outgoing items into it. The door closes and seals. The bag is turned back, comes away with its cover re-sealed, and is either kept for the next docking or discarded. Held by the flange, the pouch hangs flat against the wall during the whole transfer; the long part of the pouch hangs below the flange and the short part sits above it.
Line, variety and volume for fill-finish
The recommended configuration is Empty · indB · 10 L.
- Empty beta bags. You fill the bag in your own process with what the campaign needs. An Empty bag is available in every variety, volume and port option. Where the items are rubber stoppers, plungers, seals or caps in quantity, the Pre-loaded line loads them in our ISO Class 7 cleanroom instead, with units per bag, the sterilisation route and the validation agreed per kit; both lines are described on the Products page.
- indB, gamma sterile. The bag is supplied pre-sterilised by gamma irradiation at 25–40 kGy to SAL 10⁻⁶, released dosimetrically per batch, with a 2-year shelf life and no preparation. On a filling line this takes an autoclave cycle off the critical path: the bag is loaded, sealed and taken to the port. Choose indA, autoclavable, when the contents must be steam-sterilised together with the bag in your own validated cycle (121 °C for 30 min, one cycle, 3-year shelf life).
- 10 L. The smaller pouch suits frequent, small transfers at a filling isolator: easier to hold flat at the port and to handle with gloves inside. Take 25 L when format parts or larger loads have to cross in one docking. Both volumes carry the same 190 mm beta port. Respect the load limit of the volume you choose; the figure for each volume is shown with the configuration in Build Your Bag.
What QA receives
Every batch ships with a CoA and a CoC. The release testing behind them: a 100 % flange leak test by pressure decay (5 in. H₂O over 60 s), 100 % visual inspection, dimensional inspection to AQL 0.65, and per-batch bioburden (ISO 11737-1, ≤ 1000 CFU/bag), endotoxin (USP <85>, < 0.25 EU/mL), particulates (USP <788>, ≥ 10 µm ≤ 20/mL and ≥ 25 µm ≤ 3/mL) and weld strength (ASTM F88, ≥ 5.0 lbf/in). The porous face is a Tyvek® flash-spun HDPE microbial barrier tested to ASTM F1608 with LRV ≥ 4 as the acceptance criterion. Methods and criteria for every test are on the Proof page; measured values are shown there once a batch report carries them.
On request: an autoclave compatibility statement (indA), a post-autoclave inspection protocol, load-pattern guidance, an extractables summary, and the validation package under MNDA. The contact materials are high-temperature polycarbonate (flange and cover), platinum-cured silicone (beta seal and O-ring), HDPE (weld ring and barrier face) and multilayer LLDPE (impervious face), with USP <87> / <88> Class VI, ISO 10993-1, BSE/TSE (EMA/410/01) and REACH / RoHS positions listed on the documentation desk. Store the bags at 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat.
Which variety for this use?
For a filling isolator or closed RABS, Empty · indB · 10 L: a ready-to-use sterile bag you fill in your own process, docked to a standard or interlock-chamfer 190 mm alpha port, with up to 5 dockings per bag. Switch to indA when the bag and its contents go through your autoclave together. Switch to 25 L for format parts and larger loads. Custom sizes are made on request after an engineering review. Check the fit on your own port first: request samples for aseptic fill-finish, configure the bag in Build Your Bag, and read 190 mm alpha port compatibility: what to check before the first docking.