Beta bags for stopper loading carry the closures a filling line consumes, rubber stoppers, syringe plungers, aluminium seals and flip-off caps, into the isolator or RABS without opening the sterile boundary. 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 bag arrives ready to dock on an industry-standard 190 mm alpha port. This page describes the use case, the transfer problem it answers and the configuration we recommend for it.
The use case: closures into the filling line
A filling line consumes closures continuously. Vials need stoppers, pre-filled syringes need plungers, and both need the seals or caps that complete the container closure system. These parts are made outside the aseptic core, often in another building or another company, and they have to cross from a lower classified area into the critical zone where the product is open. In an isolator or a RABS the stopper bowl, the plunger feeder and the capping station sit inside the barrier, so every refill is a transfer across that barrier. On a long campaign the line is refilled many times per shift, and each refill is a moment where the environment can be put at risk.
The transfer problem
The classical ways in are slow, or weak, or both. Steam-sterilising components on site and passing them through a double-door autoclave ties up equipment and people and adds a cooling and drying step before the parts can be used. Passing a sealed tub through a decontamination airlock or a hatch exposes the outer wrap to the room between steps and needs its own cycle time. Every open-the-door moment has to be risk-assessed, monitored and justified, and the records build up. Volume adds a second problem: a stopper bowl holds a lot of parts, and a bag that is too small means more dockings, more handling and more risk per batch.
Beta bags for stopper loading on a 190 mm alpha port
A single-use beta bag turns the refill 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 isolator; the outer faces of both doors are never exposed to the inside. No airlock cycle is run, and the bag is discarded after use, so there is nothing to clean or revalidate between refills.
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; if you are not sure which you have, send us the alpha port model and our engineering team will confirm the fit. The bag is designed for up to 5 dockings, so a part-used bag can be removed and docked again later in the campaign. The product is supplied in a double-bag configuration, each bag overwrapped and tamper-evident sealed, and the carton carries the lot, the configuration, the dates and a QR-coded GTIN.
Which line, variety and volume
We recommend Pre-loaded · indB · 25 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 rubber stoppers, plungers, twist-off ports, aluminium seals and flip-off caps, 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 the two lines side by side on the Products page, and how a kit is agreed and loaded in Pre-loaded stoppers, ready to transfer.
- 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. This is the variety for a line that wants to dock and go.
- 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. That puts the autoclave back into the workflow this application is trying to remove, so indA fits only where you already autoclave your closures in-house and want the bag to go through the same cycle.
- 25 L. The larger useful volume keeps up with a stopper bowl and means fewer dockings per batch. The 10 L version fits smaller lots and clinical batches. 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 · 25 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. 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 a QA reviewer will ask for 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 are high-temperature polycarbonate (flange and cover), platinum-cured silicone (beta seal and O-ring), HDPE (weld ring and outer porous film) and multilayer LLDPE (inner film); their compliance covers 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. The methods and acceptance criteria of the type tests (alpha-port docking, multi-cycle docking, cover removal force, weld peel, burst, dye penetration, film tensile, microbial barrier, transit) are listed on the Proof & Documents page; the documents can be requested from there.
How a transfer runs
The operator brings the bag to the port flange-face forward, the pouch flat and parallel to the isolator 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 isolator the joined door swings inward, the stoppers or plungers are tipped through the open port into the bowl or a staging tray, the door closes, the bag turns back and comes away with its cover re-sealed. The long part of the pouch hangs below the flange throughout, so the operator can lift it to empty it completely.
Which variety for this use?
Pre-loaded · indB · 25 L: your closures 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 keeps up with a filling line. indA is the alternative for sites that autoclave their closures in-house; 10 L is the alternative for small lots. Both are built the same way and dock on the same industry-standard 190 mm alpha ports. Request samples for stopper loading, or ask for a quotation and sales will reply within one business day.