Beta bag cleanroom manufacturing decides what a transfer bag brings to the alpha port besides its contents. The DELTAQUANT 190 mm Single-Use Beta Bag is made, and for the Pre-loaded line also loaded, in the ISO Class 7 cleanroom of DeltaQuant Lifesciences FZE at the UAQ Free Trade Zone, Umm Al Quwain, U.A.E. This article explains what happens in that room, which limits every batch is tested against, and why the cleanroom class is a manufacturing claim and not a sterility claim.
Why the room matters for a transfer bag
A beta bag exists to move items across a barrier without breaking it. Everything on the bag that reaches the port, the flange, the cover, the seal and the inside of the pouch, is carried into the controlled side of your process. Whatever the bag picks up during manufacture travels with it. A classified cleanroom limits what the bag can pick up: airborne particles are controlled, the surfaces are controlled, and the people working on the bag are gowned for the class. ISO Class 7 is the class DeltaQuant operates, and it is the only cleanroom or quality claim made on this site.
What is made in the room
The bag is a flat pouch. Two faces are welded together around the edge: a clear, impervious multilayer LLDPE film and a white, breathable Tyvek® flash-spun HDPE microbial barrier. The rigid round beta flange, Ø 190 ± 0.4 mm in high-temperature polycarbonate, is sandwiched into the face of the pouch at its lower-middle, with pouch material above, below and to both sides of it. Its flat cover, also polycarbonate, faces outward. A platinum-cured LIM silicone beta seal and a platinum-cured silicone O-ring sit between cover and flange, and an HDPE weld ring is what the film is welded to. An optional removable stainless-steel pull handle never touches the product. That is all eight parts, and all of them are assembled under ISO Class 7.
For Pre-loaded beta bags the same room is where your components go in: rubber stoppers, twist-off ports, aluminium seals and flip-off caps, plungers, or other components you supply or we source. The units per bag, the sterilisation route and the validation are agreed per kit with you, and no fill count is published. The two lines, Empty beta bags and Pre-loaded beta bags, are described on the Products page, and either can be set up in Build Your Bag.
The limits every batch is tested against
Cleanroom manufacturing is only a claim until it is measured. Every batch is tested against four cleanliness limits:
- Bioburden ≤ 1000 CFU/bag, tested to ISO 11737-1.
- Endotoxin < 0.25 EU/mL, tested to USP <85>.
- Particulates ≥ 10 µm ≤ 20/mL and ≥ 25 µm ≤ 3/mL, tested to USP <788>.
- Non-fiber-releasing materials, per 21 CFR 210.3(b)(6).
These are limits, not averages, and they are reported on the CoA of the batch. Weld strength is tested per batch alongside them.
Every bag, every batch
Release testing sits on top of the batch limits. Every bag has a flange leak test by pressure decay at 5 in. H₂O for 60 s. Every bag is inspected visually. Dimensions are inspected to AQL 0.65. Per batch, bioburden, endotoxin, particulates and weld strength are tested as above. A CoA and a CoC ship with every batch. The release list and the full test bench, each test with its standard and acceptance criterion, are on Proof & Documents. A measured value from the bench is published only once a batch report carries it; until then the page shows the criterion and says so.
The materials behind the cleanliness
A low particle count means little if the materials shed. Every contact material is chosen with its compliance statements: USP <87> / <88> Class VI for biological reactivity, ISO 10993-1 for biological evaluation, FDA 21 CFR 177.1580 / 177.2600 / 177.1520 for food-contact polymers, BSE/TSE (EMA/410/01) for animal-free status, REACH / RoHS for substance restrictions and Ph. Eur. 3.1.5 for polyethylene with additives. Risk management follows ICH Q9 and ISO 14971 (FMEA). The porous face is tested as a microbial barrier to ASTM F1608 with an acceptance of LRV ≥ 4, so what the cleanroom keeps out, the barrier keeps out afterwards.
Packaging that keeps it clean
The bag leaves the room in a double-bag configuration. Each bag is overwrapped and tamper-evident sealed; the carton carries the lot, the configuration, the dates and a QR-coded GTIN, so a bag can be traced to its batch and its CoA from the outside of the box. Customer labelling and custom wrapping, for example a triple wrap, are available on request. Store the bags at 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat.
Clean is not the same as sterile
ISO Class 7 describes the room the bag is made in. It does not make the bag sterile, and the two varieties reach sterility by different routes.
indA: your autoclave
indA is supplied non-sterile and autoclaved by you: one validated cycle at 121 °C for 30 min, within 121–123 °C, with the vacuum ramp limited to ≤ 0.5 bar/min and the bag lying flat, porous face down. You validate the cycle; the autoclave compatibility statement, the post-autoclave inspection protocol and the load-pattern guidance are available on request. Shelf life is 3 years.
indB: gamma, released per batch
indB is supplied pre-sterilised by gamma irradiation at 25–40 kGy to SAL 10⁻⁶, with dosimetric release per batch and no preparation. Shelf life is 2 years. For a pre-loaded kit, the sterilisation route is agreed with you and never claimed for the components on a web page.
If a question goes beyond these pages, for example an autoclave parameter beyond the validated cycle or a result from a test still marked not yet published, the documentation set says what is covered and the figure comes with the batch report.
In practice
One case where the cleanroom is the whole point is a component maker who wants to ship stoppers, seals and ports to pharma customers ready to transfer: the components are loaded in our room, sealed, and reach the customer's alpha port without a repack. The reasoning for that use, with the recommended line, variety and volume, is on the component makers application page. To see the room's output on your own port, request samples, and ask for the CoA of the batch when they ship.