Proof & documents
Beta bag validation documents, test by test.
The beta bag validation documents DeltaQuant issues all start on this page: the method and acceptance criterion of every test, the release testing on every bag and every batch, and the certificates and protocols that travel with the single-use beta bag. A Tyvek® flash-spun HDPE face that breathes and a microbial barrier that holds. Measured values appear once a batch report carries them; until then the bench says so.
Microbial barrier · log reduction
The verification bench
Tested like a boundary should be.
Twelve tests, each with its standard and its acceptance criterion: docking, the barrier, the welds, the film, transit, and the checks specific to indA and indB. A measured value appears only once a batch report carries it; until then the bench shows the criterion and says so.
Why some values are not shown yet
A result is published only when a batch report carries it. Until then the bench shows the method and the acceptance criterion and marks the value as not yet published. The rule is the same in the studio, in the chatbot and in every document we send: no figure is quoted that cannot be traced to a report. When a measured value is released it appears here, on the gauges, and in the validation package.
Docking and the barrier
Alpha-port docking is verified by an in-house method with no barrier loss as the criterion. Multi-cycle docking uses the same method with up to 5 dockings as the criterion, which is why the bag is rated for up to 5 dockings. Cover removal force is accepted at ≤ 30 N. The microbial barrier of the porous face is tested to ASTM F1608 with an acceptance of LRV ≥ 4.
Welds, film and transit
Weld peel strength is tested to ASTM F88 with an acceptance of ≥ 5.0 lbf/in; burst to ASTM F1140, ≥ 18 kPa; seal dye penetration to ASTM F1929, no penetration. Film tensile strength and elongation are tested to ASTM D882, ≥ 25 MPa and ≥ 300 %. Transit and drop are tested to ASTM D4169 with no damage as the criterion.
indA and indB
Steam compatibility for indA is verified by an in-house method: no damage after one cycle. Gamma compatibility for indB is verified to 40 kGy, and a sterility audit looks for no growth over 14 days. The varieties themselves are compared on the Products page, and you can set either one in Build Your Bag.
Release, every batch
Nothing leaves untested.
Every bag is leak tested and inspected. Every batch is sampled, tested and certified, and the certificates travel with it. Nothing leaves untested, and nothing is certified that was not measured.
The flange leak test is a pressure-decay test at 5 in. H₂O for 60 s, on 100 % of bags. Every bag is also inspected visually, and dimensions are inspected to AQL 0.65. Per batch, bioburden is tested to ISO 11737-1 with a limit of ≤ 1000 CFU/bag, endotoxin to USP <85> with a limit of < 0.25 EU/mL, particulates to USP <788> with limits of ≤ 20/mL at ≥ 10 µm and ≤ 3/mL at ≥ 25 µm, and weld strength as above. The materials are non-fiber-releasing (21 CFR 210.3(b)(6)).
Inside the isolator
One door. Both sides.
Cover off, doors open. The transfer happens inside, and the boundary never breaks.
Cover removal force
In-house method · measured value awaiting batch report
Docking cycle
Material compliance
The paper behind the polymer.
Every product-contact material in the bag is covered by the statements a validation file expects: USP <87> / <88> Class VI for biological reactivity; ISO 10993-1 for biological evaluation; the FDA food-contact polymer regulations 21 CFR 177.1580 / 177.2600 / 177.1520; BSE/TSE (EMA/410/01), animal-free; REACH / RoHS substance restrictions; Ph. Eur. 3.1.5 for polyethylene with additives; and risk management to ICH Q9 and ISO 14971 (FMEA).
The contact materials are high-temperature polycarbonate (flange and cover), platinum-cured silicone (beta seal and O-ring), HDPE (the weld ring), Tyvek® flash-spun HDPE (the porous face) and multilayer LLDPE (the inner impervious film). The optional stainless-steel pull handle is removable and non-contact. The bags are made and, for the Pre-loaded line, loaded in an ISO Class 7 cleanroom.
Documentation desk
Paper that travels with the bag.
A certificate of analysis and a certificate of conformance ship with every batch. Statements, protocols and the validation package are prepared on request and sent with your quotation.
A CoA and a CoC come with every batch, for both lines and both varieties. Per-batch testing covers bioburden, endotoxin, particulates and weld strength against the limits above, and the carton carries the lot, the configuration, the dates and a QR-coded GTIN.
On request: the autoclave compatibility statement for indA, which gives the cycle the bag is designed for; the post-autoclave inspection protocol, which tells your operators what to check after the cycle; load-pattern guidance for the chamber; the extractables summary for the contact materials; and the validation package, released under a mutual NDA. Each row above has a Request link that opens the form with that document selected.
Qualifying a new supplier
From sample to signed-off.
A single-use beta bag is qualified the same way whatever its source: fit, process, documents. Start with samples for your own alpha port, Standard or Interlock-chamfer, and check the docking on the line that will use them.
For indA, run the bag through your own autoclave validation with the compatibility statement and the load-pattern guidance beside you; the cycle is yours to validate, and the bag is designed for one cycle at 121 °C for 30 min. For indB, sterilisation is by gamma irradiation, 25–40 kGy to SAL 10⁻⁶, with dosimetric release per batch. Then place the CoA, the CoC, the compliance statements and, under NDA, the validation package into your supplier file. Nothing in that file will carry a number that this site does not: the Products page, the configurator and the documents all read from the same verified data. The full list is in Validation checklist for a new beta bag supplier.
Next step
Ask for the paper. Or the bag.
One form, one business day. Tell us the port, the volume and the application; sales replies with the documents, a quotation or samples for your line.