Beta bag shelf life is a short answer with a few details attached. For the DELTAQUANT 190 mm single-use beta bag the figures are 3 years for indA and 2 years for indB, both counted from the date of manufacture, both for a bag stored in its overwrap under the published conditions. Those are the only shelf-life figures DeltaQuant Lifesciences FZE publishes, and they apply to every volume, port version and line. This article explains what the figures cover, how the two varieties differ, how to read the carton and how to plan stock around the dates.
The figures
- indA, the autoclavable variety, supplied non-sterile: 3 years from manufacture.
- indB, the gamma-sterile variety, supplied pre-sterilised: 2 years from manufacture.
The same two lines sit in the comparison table on the products page, next to supply state, sterilisation and preparation. They are the same for Empty beta bags and Pre-loaded beta bags, and for the 10 L and the 25 L pouch.
How the two varieties differ
The two varieties leave the cleanroom in different states. indA leaves non-sterile; the sterilisation step, one validated autoclave cycle at 121 °C for 30 min, happens in your plant on the day you choose. indB leaves sterile, gamma irradiated at 25–40 kGy to a sterility assurance level of 10⁻⁶ and released by dosimetry batch by batch. The shelf life of each variety is the period, from manufacture, for which that supply state is supported: a non-sterile bag ready to be autoclaved for indA, a sterile bag ready to dock for indB. The site does not publish the data behind either figure. What can be provided for your validation is listed on the documentation desk; ask for it with your quotation.
Counted from manufacture
Both figures run from the date of manufacture, not from the date of shipment or receipt. Each carton carries the lot, the configuration, the dates and a QR-coded GTIN, so the start and the end of the window are on the outside of the box. Two consequences follow:
- A bag that has spent time in transit has used part of its window before it reaches you. Plan orders on the dates printed on the carton, not on the delivery date.
- Shelf life is not reset by anything you do. Autoclaving an indA bag is one cycle, part of its validated use, not a renewal of the date; an indB bag is not re-sterilised.
Storage conditions
The published storage conditions are 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat. They apply for the whole of the shelf life, and they apply to the bag in its overwrap, in its carton. Each bag is overwrapped and tamper-evident sealed; the overwrap stays closed until the bag is needed.
Two lines on the verification bench relate to storage and handling. Transit and drop is tested to ASTM D4169 with an acceptance criterion of no damage. Film tensile and elongation is tested to ASTM D882 with an acceptance criterion of 25 MPa or more and 300 % or more. As with every test on the bench, the method and the criterion are published and the measured value appears when a batch report carries it.
indA: before and after the autoclave
The 3-year figure is for the bag as supplied, non-sterile, in its overwrap. The product data gives no separate figure for an indA bag after its autoclave cycle, and this page does not invent one. What the documentation set offers instead is a post-autoclave inspection protocol, an autoclave compatibility statement and load-pattern guidance, all on request, so that the bag's condition after the cycle is checked and recorded in your own system. A hold time between the cycle and the docking, if your process needs one, is set in your validation. A bag past its date is not brought back by a cycle: one cycle only is part of the validated use, and the date comes first.
indB: ready to dock, for 2 years
The 2-year figure is for the sterile bag in its overwrap. There is no preparation step and no second window to manage. The steam indicator dot belongs to indA; an indB bag is released by dosimetry, batch by batch, and goes from the overwrap to the port. The autoclave vs gamma guide sets the two varieties side by side if the choice is still open.
Planning stock
- Order against consumption. Size each order so that the bags are used well inside the window. For a slow-moving line the longer indA window matters; for a campaign that uses its bags within months, either variety fits.
- First expired, first out. Shelve by the dates on the carton and take the earliest first. The QR-coded GTIN on the carton supports scanning at goods-in.
- Match lots to certificates. A CoA and CoC come with every batch; file them by lot, with the dates, so the paperwork is found as fast as the carton.
- Label for your system. Customer labelling and custom wrapping, triple wrap for example, are available on request, and the configurator previews the label with your part number and lot fields.
- Ask before you assume. If a storage question is not answered by the conditions above, ask engineering rather than extending a figure that is not published.
In practice
Cleanroom staging is where shelf life is managed day to day: bags pre-positioned in the controlled environment, waiting for the port, each one inside its window. See beta bags for cleanroom staging, recommended as Empty · indA · 10 L, where the 3-year window gives the staging stock the most room. To check the dates and the carton for yourself, request samples for your own alpha port; sales replies within one business day.