Pre-loaded beta bag stoppers are rubber stoppers that reach your filling line already inside a DELTAQUANT 190 mm Single-Use Beta Bag. DeltaQuant Lifesciences FZE loads them in its ISO Class 7 cleanroom, seals the bag, and ships it so the components dock straight onto the alpha port, ready to transfer. The same service covers plungers, aluminium seals, flip-off caps and twist-off ports. This article sets out how the Pre-loaded line works and what is decided with you before the first kit is made.
Two lines, one bag
The DELTAQUANT range has two product lines. Empty beta bags are the bag on its own: you fill them, in your process. Pre-loaded beta bags are the same bag with your components loaded inside it: your components, loaded in our ISO Class 7 cleanroom. Both lines come in the two varieties, indA (autoclavable) and indB (gamma pre-sterilised), and the two standard volumes, 10 L and 25 L, with a Standard or an Interlock-chamfer (IC) flange. The lines are compared on the Products page.
The bag itself is a flat pouch with the rigid round 190 mm beta flange sandwiched into its face. The pouch material extends above, below and to both sides of the flange, so the components sit in the pouch behind the cover and pass through the open port once the bag is docked.
What can be loaded
The Pre-loaded line covers the components that normally have to be transferred into an isolator or a RABS before filling:
- Rubber stoppers.
- Twist-off ports.
- Aluminium seals and flip-off caps.
- Plungers.
- Other components, customer supplied or sourced.
The components are yours, or sourced to your specification. No component brand is ever published, and none is implied by the bag.
What is agreed per kit
Three things are agreed per kit with you, and only with you.
Units per bag
The count depends on the component, its packaging and the load limit of the volume you choose. It is set with your engineering team, not read off a table.
Sterilisation route
Whether the loaded bag is autoclaved by you (indA) or supplied pre-sterilised by gamma (indB), and what that means for the components inside, is agreed before the kit is specified.
Validation
The validation of the loaded kit in your process is yours; the documentation set supports it.
This is why no fill count appears anywhere on this site, in the configurator or in the chatbot. A number published for one stopper size would be wrong for another, and a sterilisation claim made for a bag cannot be made for a component it does not own. If a figure is not on this page, it is in the kit specification agreed with you and in the batch report that ships with the kit.
The bag the components travel in
The pouch has two faces: a white, breathable Tyvek® flash-spun HDPE microbial barrier and a clear, impervious multilayer LLDPE film, welded together around the edge. The flange and its cover are high-temperature polycarbonate; the beta seal is platinum-cured LIM silicone. Every contact material is listed on the Products page with its compliance statements.
For loaded components the variety recommended on every Pre-loaded application page of this site is indB: it is supplied pre-sterilised by gamma irradiation at 25–40 kGy to SAL 10⁻⁶ with dosimetric release per batch, needs no preparation and has a 2-year shelf life. indA is supplied non-sterile for your own validated autoclave cycle, one cycle at 121 °C for 30 min, and has a 3-year shelf life. The right variety for a loaded kit is part of the sterilisation route agreed with you.
The bag is supplied in a double-bag configuration. Each bag is overwrapped and tamper-evident sealed, and the carton carries the lot, the configuration, the dates and a QR-coded GTIN. Customer labelling and custom wrapping, for example a triple wrap, are available on request. Store the kits at 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat.
From our cleanroom to your port
At the line, the loaded bag is brought to the alpha port flange-first, the pouch flat and parallel to the wall. The flange engages the port and a short turn locks it; the alpha door and the beta cover become one plate. From inside the isolator the joined door swings inward, the stoppers pass through the open port, the door closes, and the bag turns back and comes away with its cover sealed again.
The bag is rated for up to 5 dockings. Alpha-port docking and multi-cycle docking are verified by in-house methods with no barrier loss and up to 5 dockings as the acceptance criteria; the cover removal force is accepted at ≤ 30 N. A measured value is shown only once a batch report carries it. The full bench, with every standard and criterion, is on Proof & Documents.
What ships with the kit
Every bag has a flange leak test by pressure decay at 5 in. H₂O for 60 s and a visual inspection. Every batch is tested for bioburden (ISO 11737-1, ≤ 1000 CFU/bag), endotoxin (USP <85>, < 0.25 EU/mL), particulates (USP <788>) and weld strength, and ships with a CoA and a CoC. On request the documentation set adds the extractables summary and, under MNDA, the validation package. For a loaded kit, the agreed units per bag and the sterilisation route are in the kit specification and the batch report, never on this page.
How to configure a pre-loaded bag
Open Build Your Bag, set the line to Pre-loaded, choose the variety, the volume and the port, then pick the kit: stoppers, twist-off ports, seals and caps, plungers or other. The studio shows the bag filling with the component you chose and writes a configuration code, for example Pre-loaded · indB · 25 L · IC · Stoppers. "Request this configuration" carries that code into the request form with everything prefilled. Sales sends a quotation within one business day, and engineering comes back with the questions that set the units per bag and the sterilisation route.
In practice
A typical pre-loaded kit is stoppers for vial filling; plungers for syringe lines are another. The reasoning for that use, with the recommended line, variety and volume, is on the vial, syringe and stopper loading application page. Makers of stoppers, seals and caps who want to ship their own components ready to transfer will find their case on the component makers application page. Either way, the first step is the same: request samples of the bag and dock them on your own port.