Beta bags for cleanroom staging hold the materials an isolator or RABS will need before the campaign starts: tools, change parts, empty containers, sampling consumables and the wipes and swabs of the next intervention. DeltaQuant Lifesciences FZE supplies them as Empty beta bags. Your team loads a DELTAQUANT 190 mm single-use beta bag in your own process, runs one validated autoclave cycle, and the sealed bag waits in the controlled environment until it is docked on an industry-standard 190 mm alpha port. This page describes the staging use case, the transfer problem behind it and the configuration we recommend.
The use case: materials pre-positioned in the controlled environment
Staging means preparing transfers before they are needed. In an aseptic facility the isolator or RABS is the critical zone and the room around it is a controlled background. Everything the critical zone will consume during a campaign has to arrive sterile and in a known state. Staging moves that preparation off the critical path: bags are loaded, sterilised, labelled and placed on a rack or in a pass-through near the port, so an operator inside the barrier can call for the next bag without waiting for a sterilisation cycle to finish.
The content of a staged bag is decided by the process owner. Typical loads are small instruments, change parts for a filling machine, empty containers for samples, cleaning tools and the consumables of a planned intervention. Because each bag is loaded by your team, the inventory of a staged bag can be matched exactly to the plan for that shift or that batch, and the label on the overwrap can carry your own part number and lot.
The transfer problem
A staged item is worth little if the act of bringing it in breaks the barrier. Opening the isolator means a new decontamination cycle before the campaign can continue; passing an item through a hatch that is not an alpha-beta port adds a decontamination step and a hold time to every transfer. Staging also creates a storage problem. A sterilised load that is not sealed inside a validated microbial barrier loses its state as soon as it leaves the autoclave, and a load sealed in the wrong material cannot be autoclaved in the first place.
The requirements are simple to state. The container must be a microbial barrier in storage. It must be a barrier to the room at the moment of transfer. It must be autoclavable with its contents, in your own cycle, with an indicator that shows the cycle ran. And it must be single-use, so that the staging stock is traceable per bag and nothing is reprocessed.
How a single-use beta bag on a 190 mm alpha port solves it
A DELTAQUANT beta bag is a flat pouch with the rigid beta flange sandwiched into its face. One face is a clear, impervious multilayer LLDPE film; the other is a white, breathable Tyvek® flash-spun HDPE microbial barrier. The flange, Ø 190 ± 0.4 mm in high-temperature polycarbonate, sits in the lower-middle of the pouch with pouch material above, below and to both sides of it. Steam passes through the porous face during the autoclave cycle; afterwards the same face is what keeps microorganisms out. The microbial barrier is tested to the acceptance criterion LRV ≥ 4 (ASTM F1608).
Because the flange is compatible with industry-standard 190 mm alpha ports, a staged bag goes straight from the rack to the port. There is no re-wrapping and no decontamination of the outside of the load: the flange cover and the alpha door are the only surfaces that ever face the room, and they mate and open together. For chamfered alpha ports the Interlock-chamfer (IC) version is available. Every bag ships in a double-bag configuration, overwrapped and tamper-evident sealed, and the carton carries the lot, the configuration, the dates and a QR-coded GTIN.
Beta bags for cleanroom staging: Empty · indA · 10 L
Empty beta bags. Staging is, by definition, loading in your own process: the content changes from shift to shift and only your team knows what the next intervention needs. The Empty line gives you a ready-to-use transfer bag in every variety, volume and port option. The Pre-loaded line, where we load your components in our ISO Class 7 cleanroom, suits recurring, identical kits rather than ad-hoc staging.
indA, autoclavable. indA is supplied non-sterile and autoclaved by you, with its contents, in one validated cycle at 121 °C for 30 min. Staging stock is produced in-house whenever the autoclave has capacity, which keeps the timing under your control. The guidance is short: keep the chamber within 121–123 °C, since 124 °C or more may damage the bag; limit the vacuum ramp to 0.5 bar/min; lay the bag flat with the porous face down; respect the load limit; run one cycle only. A steam indicator dot (ISO 11140-1 Class 1) on the bag shows that the cycle ran. Unopened stock keeps for 3 years from manufacture when stored at 13–27 °C and 30–60 % relative humidity, away from sunlight, ozone and heat. indB, gamma sterile with a 2-year shelf life, is the better choice when there is no autoclave or when zero preparation matters more than control over the cycle.
10 L. Most staged loads are small: a set of tools, a few containers, one intervention's worth of consumables. The 10 L bag, with a useful volume of 10 L, hangs flat against the isolator wall and is the easier size to place on a rack and to handle at the port. Choose 25 L when a single staged load is bulky, for example a tray or a set of larger change parts. The load limit for each volume is shown with the configuration in Build Your Bag. The hold time between autoclaving and use is set by your own validation; DeltaQuant publishes no figure for it.
What the documentation set gives QA
Every batch ships with a certificate of analysis and a certificate of conformance (CoA + CoC). Release covers a 100 % flange leak test by pressure decay at 5 in. H₂O over 60 s, 100 % visual inspection, dimensional inspection to AQL 0.65 and per-batch testing of bioburden, endotoxin, particulates and weld strength. For a staging process that depends on your autoclave, four documents are available on request:
- the autoclave compatibility statement for indA
- the post-autoclave inspection protocol
- load-pattern guidance for the chamber
- the extractables summary
A validation package is available under MNDA. The method and the acceptance criterion of every test are listed on the Proof & Documents page; measured values appear there once a batch report carries them. Together with the steam indicator dot on each bag, this gives QA a closed record per staged bag: the batch it came from, the cycle it went through and the inspection it passed before use.
How a transfer runs
The operator brings the staged bag to the port flange-face forward, the pouch flat and parallel to the isolator wall. The flange engages the alpha port and a short turn locks it; the alpha door and the beta cover become one plate. From inside the isolator the joined door swings inward, the staged items are taken out, and the door closes. The bag turns back and comes away with its cover sealed again. A bag can be docked more than once during a campaign; the multi-cycle docking method accepts up to 5 dockings.
Which variety for this use?
For cleanroom staging, DeltaQuant recommends an Empty beta bag, variety indA, 10 L: you load it, you autoclave it in one validated cycle, and it waits sealed until the port needs it. Choose indB when zero preparation outweighs control over the cycle, and 25 L for bulky loads. Configure this bag in the studio, compare both lines on the Products page, or request samples for your port. Sales replies within one business day; custom sizes are made on request after an engineering review. The related page on environmental monitoring and sampling covers the bags that go in and out of the isolator during the session itself.