The autoclave vs gamma beta bag question is the first one to settle, and it is simpler than it looks. Both varieties of the DELTAQUANT 190 mm single-use beta bag are the same bag: a flat pouch with the flange sandwiched into its face, compatible with industry-standard 190 mm alpha ports, in 10 L or 25 L, as Empty or Pre-loaded beta bags. What differs is how the bag becomes sterile, and everything that follows from that: supply state, preparation, documentation and shelf life.
Two varieties, one bag
indA is the autoclavable variety. It is supplied non-sterile and you run one validated steam cycle in your own autoclave. indB is the gamma-sterile variety. It is supplied pre-sterilised, released by dosimetry batch by batch, and needs no preparation. The flange, the beta seal, the two pouch faces and the port options are the same for both. So is the release testing: every bag is leak tested and inspected, every batch is sampled and certified, and a CoA and CoC travel with every batch. The choice does not change the bag you dock; it changes who sterilises it and when.
indA: you run the cycle
Supply state and preparation
indA arrives non-sterile in its tamper-evident overwrap. Preparation is one validated autoclave cycle at 121 °C for 30 min. The cycle is yours: DeltaQuant Lifesciences FZE states the parameters the bag is validated for, and you validate the cycle in your autoclave, with your load, in your plant.
The validated parameters
The parameters published for indA are the ones in the product data, and only those:
- Lay the bag flat, porous face down.
- Chamber at 121 °C, within the 121–123 °C band. At 124 °C or above the bag may be damaged.
- Hold for 30 min.
- Vacuum ramp of 0.5 bar/min or less.
- Respect the load limit.
- One cycle only. A second cycle is outside the validated use.
A steam indicator dot (ISO 11140-1 Class 1) on the bag shows that it has been through a steam process. It is a process indicator, not a sterility result; sterility assurance comes from your validated cycle. The documentation set adds three items on request: an autoclave compatibility statement for indA, a post-autoclave inspection protocol and load-pattern guidance. Autoclave parameters beyond the validated cycle, a different hold time or temperature for example, are not published. Where a question goes past the cycle above, the answer comes from engineering with your process details, not from a figure on this page.
What indA is for
indA suits plants with an in-house autoclave that want control over timing. The bag can sit in stock non-sterile and be sterilised the day it is needed, on the plant's own cycle and in the plant's own records. Shelf life is 3 years from manufacture.
indB: unwrap and dock
indB arrives sterile. Each batch is gamma irradiated at a validated dose of 25–40 kGy to a sterility assurance level of 10⁻⁶ and released by dosimetry. There is no preparation: the bag comes out of its overwrap and goes to the port. Two tests on the verification bench are specific to indB: gamma compatibility, with an acceptance criterion of no damage to 40 kGy, and a sterility audit, with an acceptance criterion of no growth over 14 days. As with every test on the bench, the method and the criterion are published, and the measured value appears once a batch report carries it. Shelf life is 2 years from manufacture.
indB suits lines without autoclave capacity for transfer bags, lines where the autoclave is already the slowest step of the day, and any process that wants zero preparation between stores and the port.
Side by side
- Supply state: indA non-sterile, indB pre-sterilised.
- Sterilisation: indA in the customer's autoclave at 121 °C for 30 min, one cycle; indB by gamma at 25–40 kGy, SAL 10⁻⁶.
- Preparation: indA one validated autoclave cycle; indB none, ready to use.
- Shelf life: indA 3 years from manufacture; indB 2 years from manufacture.
- Best for: indA, an in-house autoclave and control over timing; indB, zero preparation.
The same table sits on the products page, next to the full specification.
How to decide
Three questions settle the choice.
Do you have a validated autoclave cycle for transfer bags, and the capacity to run it? If yes, indA keeps sterilisation inside your own records and lets you time it to the batch. If no, or if the autoclave is already the bottleneck, indB removes the step.
How long will the bags sit in stock? indA carries 3 years from manufacture, indB 2 years. If stock turns slowly, the longer window of indA counts; if bags are ordered against a campaign and used within months, both fit. The shelf-life guide covers storage and the dates on the carton.
Is the bag Empty or Pre-loaded? For Empty beta bags the choice above is the whole decision. For Pre-loaded beta bags, where DeltaQuant loads your stoppers, plungers, seals or ports in its ISO Class 7 cleanroom, the sterilisation route of the kit is agreed with you per kit, together with units per bag and the validation. The variety of the bag is chosen in the same conversation.
Once you have decided, the configurator shows the bag in either variety and writes the configuration code that goes on your request.
What does not change
Whichever variety you choose, the bag is built in the same ISO Class 7 cleanroom from the same eight parts, and it meets the same release controls: a 100 % flange leak test by pressure decay at 5 in. H₂O over 60 s, a 100 % visual inspection, dimensional inspection to AQL 0.65, and per-batch testing of bioburden, endotoxin, particulates and weld strength. The cleanliness limits are the same for both: bioburden of 1000 CFU/bag or less by ISO 11737-1, endotoxin below 0.25 EU/mL by USP <85>, particulates by USP <788>. Steam compatibility for indA, with a criterion of no damage after one cycle, and gamma compatibility for indB are the only variety-specific lines on the bench. The proof page lists every test with its method and acceptance criterion.
In practice
A lyophilisation line that loads and unloads freeze-drying trays through the port, with an autoclave beside it and a schedule it controls, is the typical indA case: see beta bags for lyophilisation trays, recommended as Empty · indA · 25 L. An aseptic fill-finish isolator that wants sterile components at the port with no preparation is the typical indB case: see beta bags for aseptic fill-finish, recommended as Empty · indB · 10 L. Either way the next step is the same: request samples for your own alpha port, and sales replies within one business day.