DeltaQuant Lifesciences FZE is a beta bag supplier Europe can qualify from published data. We make the DELTAQUANT 190 mm Single-Use Beta Bag in our ISO Class 7 cleanroom in the UAQ Free Trade Zone, Umm Al Quwain, U.A.E., and ship it to pharmaceutical manufacturers, CDMOs, biotechnology companies and clinical manufacturing organisations across the EU, the UK and Switzerland. This page covers what a European team asks before a first purchase order: how the bag sits against EU GMP Annex 1, which documents come with each batch, how shipping from the free zone works, and how to reach sales.
What European buyers ask: Annex 1 and closed transfers
The revised EU GMP Annex 1, published in 2022 and applied from 2023, asks a sterile manufacturer to write down its contamination control strategy and to prefer closed systems over open interventions. Transfers into Grade A are one of the points QA looks at most closely. Every item that enters an isolator or a RABS has to cross the barrier by a validated route, and the strategy has to say which route, why, and what evidence sits behind it. A single-use beta bag on a 190 mm alpha port is one of those routes. The bag docks flange-first, a short turn locks it, the alpha door and the beta cover become one plate, and the contents pass through the open port. The outer faces of both doors are never exposed to the inside of the isolator.
Annex 1 also treats single-use systems as components in their own right. It expects the user to assess the supplier, the materials in contact with the product, the extractables data, the sterilisation method and the integrity of the closed system, and to hold a record of each. The documentation section below lists what DeltaQuant supplies for that assessment, so the supplier file can be complete before the first bag is docked.
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.
Documentation for the QA file
Every batch ships with a Certificate of Analysis and a Certificate of Conformance (CoA + CoC). Release testing is the same for every market: a 100 % flange leak test by pressure decay (5 in. H₂O / 60 s), 100 % visual inspection, dimensional inspection to AQL 0.65, and per-batch testing of bioburden, endotoxin, particulates and weld strength. The acceptance criteria are on the Proof & Documents page: bioburden ≤ 1000 CFU/bag by ISO 11737-1, endotoxin < 0.25 EU/mL by USP <85>, particulates ≥ 10 µm at ≤ 20/mL and ≥ 25 µm at ≤ 3/mL by USP <788>, and non-fiber-releasing per 21 CFR 210.3(b)(6).
Material compliance covers the statements a European dossier needs: USP <87> / <88> Class VI and ISO 10993-1 for biological evaluation, Ph. Eur. 3.1.5 for polyethylene with additives, a BSE/TSE (EMA/410/01) animal-free statement, REACH / RoHS, and FDA 21 CFR 177.1580 / 177.2600 / 177.1520 for the food-contact polymers. Risk management follows ICH Q9 and ISO 14971 (FMEA).
On request we supply an autoclave compatibility statement and a post-autoclave inspection protocol for indA, load-pattern guidance, an extractables summary, and the validation package under MNDA. Every test on the proof page is listed with its method and its acceptance criterion; where a measured figure is not yet published on this site, it follows with the batch documentation. Three short guides answer the questions a European QA team asks first: the validation checklist for a new beta bag supplier, shelf life explained and CoA and CoC with every batch. The Insights index lists the rest.
Shipping to Europe
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 goods-in can book the batch against the CoA without opening a carton. Customer labelling and custom wrapping, triple wrap for example, are available on request. Incoterms, the carrier, the customs paperwork and the lead time are set out in the quotation rather than on this page, because they depend on the destination country, 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 Europe
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. Figures on the certificates and on this site are in SI units, mm, L, °C and kGy, as European QA expects, and volumes are stated in litres.
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 documents listed above 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.