Beta bags for component makers turn a stopper, a seal, a cap, a plunger or a twist-off port into a ready-to-transfer product: the part your pharmaceutical customer docks on an industry-standard 190 mm alpha port. DeltaQuant Lifesciences FZE offers this as a Pre-loaded beta bag. You send us the components; we load them into a DELTAQUANT 190 mm single-use beta bag in our ISO Class 7 cleanroom; the bag goes to your customer, under your label if you wish, ready to dock. This page describes the use case, the transfer problem your customers have, and the configuration we recommend.
The use case: ready-to-transfer components for pharmaceutical customers
Makers of primary packaging components sell into filling lines that run inside isolators and RABS. Those lines consume rubber stoppers, plungers, aluminium seals, flip-off caps and twist-off ports in quantity, and every one of them crosses the sterile boundary before it meets a vial or a syringe. A customer who receives components in bulk has to wash, sterilise and transfer them in-house, or buy ready-to-use components from a supplier who has done that work for them. The second option is where filling operations are moving, and the beta bag is the packaging that makes it possible: it is at once the sterile barrier pack and the transfer container.
For the component maker this is a product decision rather than a packaging detail. A ready-to-transfer presentation removes work from the customer's aseptic core, shortens the customer's qualification of the incoming part, and sets the component apart from the same part sold in bulk.
The transfer problem
Seen from your customer's side, bulk components arrive in a liner or a drum that is not a transfer container. De-bagging, washing, sterilisation and a transfer through a hatch are all steps inside the customer's facility, each with its own validation and hold time. A ready-to-use component solves this only if its packaging is itself a validated microbial barrier, docks on the customer's alpha port and survives shipping intact.
Seen from your side, loading sterile components into a transfer bag needs a controlled environment, a loading process with its own release testing, and documentation the customer's QA will accept. None of that is the core business of a moulding, stamping or coating plant. The gap between a good component and a ready-to-transfer component is exactly the loading, the cleanroom and the paperwork.
How a single-use beta bag on a 190 mm alpha port solves it
A DELTAQUANT beta bag is a flat pouch with the rigid beta flange sandwiched into its face. The clear face is an impervious multilayer LLDPE film, so the customer sees the components through the bag before docking; the white face is a breathable flash-spun HDPE microbial barrier, tested to the acceptance criterion LRV ≥ 4 (ASTM F1608). The flange, Ø 190 ± 0.4 mm in high-temperature polycarbonate, is compatible with industry-standard 190 mm alpha ports, with an Interlock-chamfer (IC) version for chamfered ports. Every contact material is listed on the Products page.
We load your components into that bag in our ISO Class 7 cleanroom. The loaded bag ships in a double-bag configuration, overwrapped and tamper-evident sealed; 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, so the pack that reaches the filling site carries your name and your part number. Transit and drop performance is tested to ASTM D4169 with the acceptance criterion of no damage, and the cover removal force method sets an acceptance criterion of ≤ 30 N, so the operator inside the isolator opens the joined door without force.
Beta bags for component makers: Pre-loaded · indB · 25 L
Pre-loaded beta bags. This is the line built for component makers: your components, loaded in our ISO Class 7 cleanroom. We load rubber stoppers, twist-off ports, aluminium seals and flip-off caps, plungers, and other components that you supply or we source. Units per bag, the sterilisation route and the validation are agreed per kit with you. None of them is published as a fixed figure, because every component and every customer specification is different. The Empty line, which your customer loads in their own process, is the alternative when the customer insists on loading in-house.
indB, gamma sterile. The bag variety is indB: supplied pre-sterilised by gamma irradiation at 25–40 kGy to a sterility assurance level of 10⁻⁶, with dosimetric release per batch and a 2-year shelf life 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 documented in the validation; we publish no sterilisation claim for a kit. indA, autoclavable with a 3-year shelf life, suits a customer who wants to run a validated 121 °C cycle on the loaded bag; few component programmes do.
25 L. Components are consumed in quantity, and a 25 L bag, with a useful volume of 25 L, carries more per docking, so the customer refills the line less often per shift. Choose 10 L for small components with a low consumption rate, or for a trial lot while the customer qualifies the presentation. Units per bag are agreed per kit; the load limit for each volume is shown with the configuration in Build Your Bag.
What the documentation set gives QA
Your customer's incoming QA receives the same documentation set as a direct DeltaQuant customer. Every batch ships with a certificate of analysis and a certificate of conformance (CoA + CoC). Release covers a 100 % flange leak test by pressure decay at 5 in. H₂O over 60 s, 100 % visual inspection, dimensional inspection to AQL 0.65 and per-batch testing of bioburden, endotoxin, particulates and weld strength. Contact materials are covered by USP <87> and <88> Class VI biological reactivity and ISO 10993-1 biological evaluation; the full compliance list is on the Proof page. On request:
- the extractables summary
- the validation package, under MNDA
- for an indA programme, the autoclave compatibility statement, the post-autoclave inspection protocol and load-pattern guidance
Gamma compatibility of the bag is verified to 40 kGy and the sterility audit for indB looks for no growth over 14 days. The method and the acceptance criterion of every test are listed on the Proof & Documents page; measured values appear there once a batch report carries them. For the kit itself, the validation agreed with you becomes part of the package your customer receives.
How a transfer runs at your customer's line
The operator brings the loaded bag to the port flange-face forward, the pouch flat and parallel to the isolator wall. The flange engages the alpha 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 components pass into the line, and the door closes. The bag turns back and comes away with its cover sealed again. The multi-cycle docking method accepts up to 5 dockings per bag, so a part-used bag can be re-docked later in the shift.
Which variety for this use?
For component makers, DeltaQuant recommends a Pre-loaded beta bag, variety indB, 25 L: your components loaded in our ISO Class 7 cleanroom, in the bag variety that is supplied gamma sterile, with the kit's sterilisation route agreed per kit, in the volume that keeps refills on the line to a minimum. Choose 10 L for trial lots and small parts, and indA only for a customer who runs their own cycle. Configure this bag in the studio, compare both lines on the Products page, request samples or ask for a quotation. Sales replies within one business day. The related page on vial, syringe and stopper loading describes the same bag from the filling line's side.