190 mm beta bags. Empty, or pre-loaded.

It is a flat pouch with a rigid 190 mm beta flange sandwiched into its face. The flange docks to industry-standard 190 mm alpha ports on isolators, RABS and filling lines, so components, product or waste cross the sterile boundary without opening it. The flange measures Ø 190 ± 0.4 mm and the bag is supplied in a double-bag configuration. An Interlock-chamfer (IC) version fits chamfered alpha ports. Custom sizes are possible after an engineering review.

indA is supplied non-sterile and autoclaved by you: one validated cycle at 121 °C for 30 min, with a 3-year shelf life. indB is supplied pre-sterilised by gamma irradiation at 25–40 kGy to SAL 10⁻⁶, released dosimetrically per batch, with a 2-year shelf life and no preparation. Choose indA when you have an in-house autoclave and want control over timing; choose indB when you want zero preparation.

Lay the bag flat with the porous face down and run one validated cycle at 121 °C for 30 min. Keep the chamber within 121–123 °C; 124 °C or more may damage the bag. Limit the vacuum ramp to 0.5 bar/min, respect the load limit of the size you use, and run one cycle only. A steam indicator dot (ISO 11140-1 Class 1) on the bag serves as the process indicator. You validate the cycle; an autoclave compatibility statement and a post-autoclave inspection protocol are available on request.

indB bags are gamma irradiated at 25–40 kGy to a sterility assurance level of 10⁻⁶ and released dosimetrically, batch by batch. Gamma compatibility is verified to 40 kGy and a sterility audit looks for no growth over 14 days; the method and acceptance criterion of each test are listed on the Proof page, and measured values appear only once a batch report carries them. The bag arrives ready to use: unwrap, dock, transfer.

indA has a 3-year shelf life from manufacture; indB has a 2-year shelf life from manufacture. Store the bags at 13–27 °C and 30–60 % relative humidity, away from sunlight, ozone and heat. Each bag is overwrapped and tamper-evident sealed, and the carton carries the lot, the configuration, the dates and a QR-coded GTIN, so the remaining shelf life can be read without opening the pack.

The bag is single-use but multi-connect: it is rated for up to 5 dockings to the alpha port. Multi-cycle docking is verified by an in-house method with up to 5 dockings as the acceptance criterion, and alpha-port docking with no barrier loss as the criterion; the measured results appear on the Proof page once a batch report carries them. After its last docking the bag is discarded, never cleaned and reused.

Two standard volumes: 10 L and 25 L useful volume, both on the same 190 mm flange and both available in indA and indB, Empty or Pre-loaded. The maximum load for each size is shown on the product cards. Other sizes are made to order after an engineering review: tell us the port, the contents and the volume you need, and engineering confirms what is possible before a quotation is prepared.

The Standard version fits standard 190 mm alpha ports. The Interlock-chamfer (IC) version is made for chamfered alpha ports. If you are not sure which you have, give the alpha port model on the request form and engineering confirms the right flange before anything ships. Samples let you check the fit on your own port, with your own line, before you order.

Yes. The Pre-loaded line is loaded with your components in our ISO Class 7 cleanroom so they arrive ready to transfer: 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, so none of them is published as a fixed figure. Configure a kit in Build Your Bag and request a quotation.

Every bag passes a 100 % flange leak test by pressure decay at 5 in. H₂O for 60 s and a 100 % visual inspection; dimensions are inspected to AQL 0.65. Every batch is tested for bioburden (≤ 1000 CFU/bag, ISO 11737-1), endotoxin (< 0.25 EU/mL, USP <85>), particulates (≤ 20/mL at ≥ 10 µm and ≤ 3/mL at ≥ 25 µm, USP <788>) and weld strength. Nothing leaves untested.

A certificate of analysis and a certificate of conformance (CoA + CoC) ship with every batch. On request, and sent with your quotation: an autoclave compatibility statement for indA, a post-autoclave inspection protocol, load-pattern guidance, an extractables summary, and the validation package under a mutual NDA. Material compliance covers USP <87> / <88> Class VI, ISO 10993-1, FDA 21 CFR 177.1580 / 177.2600 / 177.1520, BSE/TSE (EMA/410/01), REACH / RoHS and Ph. Eur. 3.1.5.

Use the request form: choose samples, a quotation or a question, tell us the application, the alpha port and the volume, and sales replies within one business day. A configuration built in Build Your Bag travels with the request. No prices are published; the quotation is prepared for your configuration and quantity. For anything urgent, write to sales@beta-bags.com or talk to the transfer specialist on any page.