DeltaQuant Lifesciences FZE supplies the DELTAQUANT 190 mm Single-Use Beta Bag to pharmaceutical manufacturers, CDMOs and biotechnology companies in the United States. As a beta bag supplier USA teams reach from the U.A.E., we make the bag in our ISO Class 7 cleanroom in the UAQ Free Trade Zone, Umm Al Quwain, and ship it from there with a Certificate of Analysis and a Certificate of Conformance on every batch. This page sets out what a US QA, validation or procurement team asks before the first purchase order: how the bag fits FDA's expectations for aseptic processing, what the validation package contains, how shipping and units work, and how to reach sales.
FDA expectations for aseptic processing
FDA's Guidance for Industry on sterile drug products produced by aseptic processing (2004) and the cGMP regulations for finished pharmaceuticals set the frame a US site works in. The critical area where product and closures are exposed must be protected, every intervention and transfer into it must be justified and monitored, and components that reach it must arrive in a state the process has validated. Isolators and RABS reduce the interventions; what remains is the transfer of materials across the barrier. Inspectors look at how that transfer is done, how the route was validated and what records show it is under control. The agency also expects a sterile manufacturer to qualify the suppliers of components that touch the process, to know the materials of construction, and to hold the data on biological reactivity, extractables and sterilisation.
A single-use beta bag on an industry-standard 190 mm alpha port, often called a rapid transfer port or RTP, closes that transfer. The bag docks flange-first, a short turn locks it, the alpha door and the beta cover open together as one plate, and the contents pass through without the outer face of either door being exposed to the inside of the isolator. With the indB variety nothing is autoclaved on site and no airlock cycle is run.
The product
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. 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. Two product lines: Empty beta bags, which you fill in your own process, and Pre-loaded beta bags, which we load with your components in our ISO Class 7 cleanroom. Two varieties: indA, supplied non-sterile and autoclaved by the customer in one validated cycle at 121 °C for 30 min, with a 3-year shelf life; and indB, supplied pre-sterilised by gamma irradiation at 25–40 kGy to SAL 10⁻⁶ with dosimetric release per batch, with a 2-year shelf life. Two standard volumes, 10 L and 25 L, and custom sizes on request after an engineering review. The bag is rated for up to 5 dockings. The Products page has the full comparison; Build Your Bag sets the configuration.
The validation package
A defined package is easier to file than a pile of certificates. This is what DeltaQuant supplies.
- A Certificate of Analysis and a Certificate of Conformance with every batch.
- Material compliance statements: USP <87> / <88> Class VI biological reactivity, ISO 10993-1 biological evaluation, FDA 21 CFR 177.1580 / 177.2600 / 177.1520 for the food-contact polymers, a BSE/TSE (EMA/410/01) animal-free statement, REACH / RoHS and Ph. Eur. 3.1.5. Risk management per ICH Q9 and ISO 14971 (FMEA).
- Release testing on every batch: a 100 % flange leak test by pressure decay (5 in. H₂O / 60 s), 100 % visual inspection, dimensional inspection to AQL 0.65, and bioburden, endotoxin, particulates and weld strength per batch. Acceptance criteria: bioburden ≤ 1000 CFU/bag (ISO 11737-1), endotoxin < 0.25 EU/mL (USP <85>), particulates ≥ 10 µm at ≤ 20/mL and ≥ 25 µm at ≤ 3/mL (USP <788>), non-fiber-releasing (21 CFR 210.3(b)(6)).
- For indB: gamma sterilisation at 25–40 kGy to SAL 10⁻⁶ with dosimetric release per batch; the sterility audit method is no growth over 14 days. For indA: an autoclave compatibility statement, a post-autoclave inspection protocol and load-pattern guidance. The customer validates the cycle: 121 °C for 30 min, one cycle only, a vacuum ramp of no more than 0.5 bar/min, and never 124 °C or above, which may damage the bag.
- On request: an extractables summary and the full validation package under MNDA.
The methods for alpha-port docking, multi-cycle docking, cover removal force, weld peel strength (ASTM F88), burst (ASTM F1140), seal dye penetration (ASTM F1929), film tensile and elongation (ASTM D882), microbial barrier (ASTM F1608) and transit and drop (ASTM D4169) are listed with their acceptance criteria on the Proof & Documents page. A measured figure is published there once it has been measured; until then it follows with the batch documentation. The validation checklist for a new beta bag supplier turns this list into a set of questions, and two short guides cover shelf life and CoA and CoC with every batch. The Insights index lists the rest.
Units
Every figure on the certificates and on this site is in SI units: mm, L, °C and kGy. Volumes are stated in litres, 10 L and 25 L. No fluid-ounce equivalent is published, because none exists in our verified data; if your documentation system needs one, treat the litre figure as the controlled value and note the conversion as your own.
Shipping to the United States
Bags ship from the UAQ Free Trade Zone, Umm Al Quwain, U.A.E. Each bag is overwrapped and tamper-evident sealed and supplied in a double-bag configuration. Cartons carry the lot, the configuration, the dates and a QR-coded GTIN, so receiving can book the batch against the CoA without opening a carton. Customer labelling and custom wrapping, triple wrap for example, are available on request. The incoterm, the carrier, the customs broker and the lead time are set out in the quotation, not on this page, because they depend on the destination, the quantity and whether the order is Empty or Pre-loaded. Store the bags at 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat, as the label states.
Contact for the United States
One sales desk, at the headquarters in the UAQ Free Trade Zone, Umm Al Quwain, U.A.E., serves every region. Write to the e-mail address or call the number in the contact card on this page; a quotation follows within one business day of your request. We do not publish desk hours; the first reply confirms them and the overlap with your working day. For a first contact from the United States, e-mail is the simplest route.
Request samples or a quotation
Tell us the alpha port model, the line (Empty or Pre-loaded), the variety, the volume and the application, and whether you need the validation package with the samples. Use the request form, set the configuration first in Build Your Bag, or read the Products and Proof & Documents pages. For Pre-loaded beta bags, units per bag, the sterilisation route and the validation are agreed per kit with you; we do not publish a fill count or a kit sterilisation claim.