A beta bag validation checklist is short when the supplier publishes its data. This one is written for the DELTAQUANT 190 mm Single-Use Beta Bag from DeltaQuant Lifesciences FZE, but every item is a question you can put to any supplier of a single-use beta bag. Each answer below comes from the verified technical data behind this site. Where a figure is not published yet, the checklist says so, and the figure comes with the batch report.
Start with the fit
The bag is a flat pouch with a rigid round beta flange sandwiched into its face. The flange is the part that meets your equipment, so qualification starts there. The flange diameter is Ø 190 ± 0.4 mm, and the bag is compatible with industry-standard 190 mm alpha ports. Two flange versions exist: Standard, for standard 190 mm alpha ports, and Interlock-chamfer (IC), for chamfered alpha ports. If you are not sure which port you have, give engineering the alpha port model on the request form and the right flange is confirmed before samples ship.
Two standard volumes exist, 10 L and 25 L. Custom sizes are available on request after an engineering review. The bag is single-use but multi-connect: it is rated for up to 5 dockings. Set line, variety, volume and port in Build Your Bag and the configuration code travels with your request.
Know what the bag is made of
Ask for the full list of contact materials. The DELTAQUANT bag has eight parts. The beta flange and its cover are high-temperature polycarbonate. The beta seal is platinum-cured LIM silicone and the O-ring is platinum-cured silicone. An HDPE weld ring is what the film is welded to. The outer porous face is a Tyvek® flash-spun HDPE microbial barrier; the inner impervious face is a multilayer LLDPE film. A removable stainless-steel pull handle is optional and never touches the product.
The material compliance statements cover USP <87> / <88> Class VI and 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, Ph. Eur. 3.1.5 and risk management under ICH Q9 and ISO 14971 (FMEA). The anatomy and the materials are set out on the Products page.
Ask for the methods and the acceptance criteria
A supplier should name the standard and the acceptance criterion of every test before any result is discussed. For the DELTAQUANT bag they are:
Docking and barrier
- Alpha-port docking: in-house method, no barrier loss.
- Multi-cycle docking: in-house method, up to 5 dockings.
- Cover removal force: in-house method, ≤ 30 N.
- Microbial barrier of the porous face: ASTM F1608, LRV ≥ 4.
Welds, film and transit
- Weld peel strength: ASTM F88, ≥ 5.0 lbf/in.
- Burst: ASTM F1140, ≥ 18 kPa.
- Seal dye penetration: ASTM F1929, no penetration.
- Film tensile and elongation: ASTM D882, ≥ 25 MPa and ≥ 300 %.
- Transit and drop: ASTM D4169, no damage.
Variety-specific
- Steam compatibility (indA): in-house method, no damage after one cycle.
- Gamma compatibility (indB): in-house method, to 40 kGy.
- Sterility audit (indB): in-house method, no growth over 14 days.
A measured value is published only when a batch report carries it. Until then the bench on Proof & Documents shows the criterion and marks the value as not yet published. Treat that as a good sign: a supplier that quotes a number it cannot trace to a report is the one to question.
Check the release testing
Release testing is what protects you batch after batch, so ask what is done on every bag and what is done on every batch. Every DELTAQUANT bag has a flange leak test by pressure decay at 5 in. H₂O for 60 s, and every bag is inspected visually. 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)).
File the documents
A CoA and a CoC ship with every batch. On request the documentation set adds the autoclave compatibility statement for indA, the post-autoclave inspection protocol, the load-pattern guidance and the extractables summary. The validation package is available under MNDA. Where a buyer question goes beyond these documents, for example a docking count beyond the rated up to 5 or a measured value from a test on the bench, the answer is not a figure from a web page: the documentation set says what is covered, and the figure comes with the batch report.
Qualify the variety you will use
The two varieties are qualified differently, so decide early. indA is supplied non-sterile and autoclaved by you: one validated cycle at 121 °C for 30 min, within a band of 121–123 °C, because 124 °C or more may damage the bag. The vacuum ramp is limited to ≤ 0.5 bar/min, the bag lies flat with the porous face down, the load limit of the volume is respected and the cycle runs once only. A steam indicator dot (ISO 11140-1 Class 1) shows the bag has seen steam. You validate the cycle; the compatibility statement and the load-pattern guidance are written to sit beside your protocol. Shelf life is 3 years from manufacture.
indB is supplied pre-sterilised by gamma irradiation at 25–40 kGy to SAL 10⁻⁶, with dosimetric release per batch. There is no preparation. Shelf life is 2 years from manufacture. Both varieties are stored at 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat.
The checklist
- Flange Ø 190 ± 0.4 mm; Standard or IC confirmed against your alpha port.
- Volume 10 L or 25 L, or a custom size after engineering review.
- Eight contact materials listed, with the compliance statements.
- Every test named with its standard and its acceptance criterion.
- Release testing on every bag and on every batch, with the limits.
- CoA and CoC with the batch; the on-request documents in the supplier file.
- Variety chosen, and either your autoclave validation (indA) or the dosimetric release (indB) filed.
- Samples tested on your own port before the first order.
In practice
A typical place to start a new-supplier qualification is aseptic fill-finish, where the bag carries sterile components into the filling isolator without breaking the barrier. The reasoning for that use, with the recommended line, variety and volume, is on the aseptic fill-finish application page. When the checklist is complete, request samples and run them on your own port. A quotation follows within one business day.