DeltaQuant Lifesciences FZE is a beta bag supplier India's sterile injectable manufacturers and CDMOs 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 from there. This page covers what an Indian QA, production or procurement team asks: why ready-to-transfer components matter on a site with several isolator lines, what the two product lines are, which documents travel with each batch, how shipping works, and how to reach sales.
Isolator lines and the need for ready-to-transfer components
India has one of the densest concentrations of sterile injectable manufacturing anywhere: vial, pre-filled syringe and lyophilisation lines for domestic supply and for export to regulated markets, and a CDMO sector that fills for customers in Europe and the United States. Those lines increasingly run in isolators and RABS, partly because the export markets inspect to EU GMP Annex 1 and to FDA's aseptic processing guidance, and partly because the revised Schedule M of 2023 brought India's own GMP closer to the PIC/S and WHO texts. A closed transfer into the Grade A zone, with a validated route and a qualified supplier for the single-use system that makes it, is now expected on every new line.
The density creates a specific need: components. A site with several isolator lines consumes rubber stoppers, plungers, aluminium seals and flip-off caps continuously, and every refill is a transfer across the barrier. Steam-sterilising closures on site and passing them through a double-door autoclave ties up equipment between batches; passing tubs through an airlock costs a cycle each time. Ready-to-transfer components in a single-use beta bag turn each refill into a closed docking on a 190 mm alpha port, sometimes called a rapid transfer port or RTP. That is why this page starts with Pre-loaded beta bags, and why Empty beta bags for product, sterile API powder, lyophilisation trays and aseptic waste come next.
Pre-loaded beta bags for component supply
You send us the components, we load them into the bag in our ISO Class 7 cleanroom, and the bag arrives ready to dock. The components can be rubber stoppers, twist-off ports, aluminium seals and flip-off caps, plungers, 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 Units per bag, the sterilisation route and the validation are agreed per kit with you; we do not publish a fill count, a component brand or a kit sterilisation claim. The same service suits Indian makers of stoppers, seals and ports who want to ship ready-to-transfer components to their own pharmaceutical customers. The stopper loading page describes the use case in detail, and the Products page lists every application with the configuration we recommend for it.
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 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 CDSCO, WHO GMP and export audits
Every batch ships with a Certificate of Analysis and a Certificate of Conformance (CoA + CoC). Release testing covers 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, against the acceptance criteria published on the Proof & Documents page. Material compliance statements cover USP <87> / <88> Class VI, ISO 10993-1, FDA 21 CFR 177.1580 / 177.2600 / 177.1520, a BSE/TSE (EMA/410/01) animal-free statement, REACH / RoHS and Ph. Eur. 3.1.5; risk management follows ICH Q9 and ISO 14971 (FMEA). On request: 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 is listed with its method and acceptance criterion; where a measured figure is not yet published on this site, it follows with the batch documentation. The validation checklist for a new beta bag supplier, the guide to shelf life and the note on CoA and CoC with every batch answer the questions an audit-facing QA team asks first. The Insights index lists the rest.
Shipping to India
Bags ship from the UAQ Free Trade Zone, Umm Al Quwain, U.A.E., by air or by sea to the Indian port of entry your site uses. The quotation states the incoterm, the carrier, the documents Indian customs require and the lead time; nothing on this page is a delivery promise. 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. Store the bags at 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat, as the label states; in the monsoon months the humidity limit is the one to watch.
Contact for India
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, 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.