Beta bags for RABS bring pre-sterilised items, aluminium seals and flip-off caps, rubber stoppers, plungers and twist-off ports, into a restricted access barrier system through its alpha port, so that the barrier stays closed while the line is resupplied. DeltaQuant Lifesciences FZE supplies them as Pre-loaded beta bags: you send us the components, we load them into a DELTAQUANT 190 mm single-use beta bag in our ISO Class 7 cleanroom, and the loaded bag arrives ready to dock on an industry-standard 190 mm alpha port. This page describes the use case, the transfer problem and the configuration we recommend for it.
The use case: resupplying a RABS without opening it
A RABS keeps the operator outside the critical zone with a rigid wall and glove ports, like an isolator, but it stands in a classified room and relies on that room, the airflow and a strict door regime rather than on a sealed, decontaminated enclosure. The doors are opened only for defined, rare interventions, and every opening is recorded and justified. That makes material entry the daily question: closures for the capping station, stoppers for a format change, plungers for a syringe line and the small tools a line needs all have to get in, several times per shift, without the doors moving. Lines that were built around a RABS are often older lines with no autoclave in the suite, which rules out the classical route of sterilising components on site and passing them through a double-door steriliser.
The transfer problem
The options without an alpha port are a transfer hatch, a mouse hole for containers or, in the worst case, a door opening. A hatch exposes the outer wrap of the components to the room between steps and needs its own decontamination and cycle time. A mouse hole suits a stream of containers, not a batch of loose closures. A door opening is an intervention with all that follows from it. The components themselves add a problem: closures arrive from the maker in bulk packaging that was never meant to cross a barrier, so someone has to repack, re-sterilise and document them before they can go in, and that work is repeated for every delivery.
Beta bags for RABS on a 190 mm alpha port
A single-use beta bag on the RABS wall turns the resupply into a closed transfer. The DELTAQUANT bag is a flat pouch with the rigid 190 mm beta flange sandwiched into its face: a clear film face on one side, a white Tyvek® flash-spun HDPE microbial barrier face on the other, welded together around the edge, with the flange mounted into the face at the lower middle of the pouch. The flange cover docks to the alpha port, a short turn locks it, and the alpha door and the beta cover open together as one plate. The components pass through the open port into the RABS; the outer faces of both doors are never exposed to the inside, and no door of the RABS has moved. Because the bag is loaded in our ISO Class 7 cleanroom, the repacking and the paperwork that went with it disappear from the suite.
The flange is made to Ø 190 ± 0.4 mm and is compatible with industry-standard 190 mm alpha ports. An interlock-chamfer (IC) version exists for chamfered alpha ports; send us the alpha port model fitted to your RABS and engineering will confirm the fit; what to look at on the port is set out in 190 mm alpha port compatibility: what to check. The bag is designed for up to 5 dockings, so a bag that is only part-emptied can be removed and docked again later. The product is supplied in a double-bag configuration, each bag overwrapped and tamper-evident sealed; the carton carries the lot, the configuration, the dates and a QR-coded GTIN.
Which line, variety and volume
We recommend Pre-loaded · indB · 10 L for this application.
- Pre-loaded beta bags. We load the customer's components into the bag in our ISO Class 7 cleanroom so they arrive ready to transfer. The components can be aluminium seals and flip-off caps, rubber stoppers, plungers, twist-off ports, or other components you supply or we source. Units per bag, the sterilisation route and the validation are agreed per kit with you; we do not publish a fill count or a sterilisation claim for a kit. See both lines side by side on the Products page.
- indB, gamma sterile. The bag variety is supplied pre-sterilised by gamma irradiation at 25–40 kGy to SAL 10⁻⁶, with dosimetric release per batch and a shelf life of 2 years from manufacture. Those are the facts of the bag; the sterilisation route of the loaded kit as a whole is agreed with you per kit, and we publish no sterilisation claim for a kit. A RABS line that has no autoclave in the suite, or that wants to dock and go, is the case indB was made for.
- Why not indA for this use. An indA bag is supplied non-sterile and autoclaved by the customer in one validated cycle at 121 °C for 30 min, which only makes sense where the site already autoclaves its closures and wants the bag to go through the same cycle. It is available, with a 3-year shelf life, for sites set up that way.
- 10 L. RABS lines tend to run smaller, more frequent batches than a large filling isolator, and a 10 L pouch is easier to handle flat against the wall at glove height and to empty through the port. The 25 L version suits long campaigns and bulk closures. The load limit for each volume is shown with the configuration in Build Your Bag.
Set this configuration up in Build Your Bag: Pre-loaded · indB · 10 L. Custom sizes are made on request after an engineering review.
What the documentation set gives QA
Every batch ships with a CoA and a CoC. On request we provide the autoclave compatibility statement (indA), the post-autoclave inspection protocol, load-pattern guidance, an extractables summary and the validation package under MNDA. For indB the type tests QA asks about are gamma compatibility (in-house method, to 40 kGy) and the sterility audit (in-house method, no growth over 14 days), alongside alpha-port docking (no barrier loss), multi-cycle docking (up to 5 dockings) and the microbial barrier of the porous face (ASTM F1608, LRV ≥ 4). Release testing covers a 100 % flange leak test by pressure decay (5 in. H₂O / 60 s), 100 % visual inspection, dimensional inspection at AQL 0.65 and per-batch testing of bioburden, endotoxin, particulates and weld strength.
The cleanliness limits are bioburden ≤ 1000 CFU/bag (ISO 11737-1), endotoxin < 0.25 EU/mL (USP <85>), particulates ≥ 10 µm ≤ 20/mL and ≥ 25 µm ≤ 3/mL (USP <788>) and non-fiber-releasing per 21 CFR 210.3(b)(6). The product-contact materials, high-temperature polycarbonate, platinum-cured silicone, HDPE and multilayer LLDPE, are covered by USP <87> / <88> Class VI, ISO 10993-1, FDA 21 CFR 177.1580 / 177.2600 / 177.1520, BSE/TSE (EMA/410/01), REACH / RoHS and Ph. Eur. 3.1.5, and the risk management follows ICH Q9 and ISO 14971 (FMEA). Every method and acceptance criterion, and the request link for each document, is on the Proof & Documents page. Storage before use: 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat.
How a transfer runs
The operator takes the bag out of its overwrap, checks the label and brings it to the port flange-face forward, the pouch flat and parallel to the RABS wall. The bayonets on the flange engage the alpha port and a short turn locks the bag; the alpha door and the beta cover become one plate. From inside the barrier, through the glove ports, the joined door swings inward, the seals or stoppers are tipped through the open port into the feeder or a staging tray, the door closes, the bag turns back and comes away with its cover re-sealed. The RABS doors have not moved, and the transfer is recorded against the lot on the carton.
Which variety for this use?
Pre-loaded · indB · 10 L: your components loaded in our ISO Class 7 cleanroom, in the indB bag variety, which is supplied gamma sterile, with the sterilisation route of the loaded kit agreed per kit, in the volume that handles well at a RABS wall. indA is the alternative for sites that autoclave their closures in-house; 25 L is the alternative for long campaigns. Both are built the same way and dock on the same industry-standard 190 mm alpha ports. Request samples for your RABS, or ask for a quotation and sales will reply within one business day.