Beta bags for environmental monitoring carry the plates, swabs and sampler parts that an environmental monitoring (EM) programme consumes into the isolator, and bring the exposed samples back out, without opening the sterile boundary. DeltaQuant Lifesciences FZE supplies them as Empty beta bags: your QC team loads a DELTAQUANT 190 mm single-use beta bag, and because the recommended variety is indB, gamma sterile, the bag is ready to use with no preparation. It docks on an industry-standard 190 mm alpha port. This page describes the EM use case, the transfer problem it creates and the configuration we recommend.
The use case: sampling tools in, exposed samples out
Environmental monitoring in an isolator or RABS happens during the process, not around it. Settle plates are exposed for the duration of the filling operation, contact plates and swabs are taken from gloves and surfaces at defined points, and active air samplers need their heads placed and retrieved. Each of these items has to go in before the session and come out after it, and the samples that come out have to reach the microbiology laboratory intact, labelled and in the state they left the critical zone.
The traffic is two-way and it is frequent. A monitoring plan for one session can call for plates at several locations, a sequence of exposures and a set of swabs at the end. Every one of those movements is a transfer across the barrier, and each one is recorded against the batch.
The transfer problem
A monitoring programme that disturbs the environment it measures is worth little. Passing plates through a hatch with its own decontamination step delays the sample, exposes the plate medium to the decontaminating agent and gives the laboratory an exposure time that includes the hatch cycle. Carrying exposed plates out through a door is not an option during a campaign. And a plate that leaves the isolator must stay a closed sample until it is incubated: contamination picked up in the corridor is a false positive, and a false positive costs an investigation.
The requirements follow from that. The container must keep the room out of the sample and the sample out of the room. The transfer must take seconds, not a cycle. The bag must be sterile when it is opened inside the isolator, without a sterilisation step that the plates and swabs could not survive. And the same port must serve the way in and the way out during one session.
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. The clear face, an impervious multilayer LLDPE film, lets the operator see the plates and read their labels through the bag before the transfer. The white face is a breathable Tyvek® flash-spun HDPE microbial barrier, tested to the acceptance criterion LRV ≥ 4 (ASTM F1608). The flange, Ø 190 ± 0.4 mm in high-temperature polycarbonate, is compatible with industry-standard 190 mm alpha ports; an Interlock-chamfer (IC) version exists for chamfered ports.
Loaded plates go into the bag in the laboratory or the preparation area. The bag docks, the joined door opens, and the plates are placed. At the end of the session the exposed plates are returned into a bag docked on the same port, the door closes, and the bag comes away with its cover sealed, so the samples travel to incubation inside a closed microbial barrier. The bag is specified so that it does not add to what the plates measure. The cleanliness limits per bag are bioburden ≤ 1000 CFU/bag (ISO 11737-1), endotoxin < 0.25 EU/mL (USP <85>) and particulates ≤ 20/mL at ≥ 10 µm and ≤ 3/mL at ≥ 25 µm (USP <788>); the materials are non-fibre-releasing.
Beta bags for environmental monitoring: Empty · indB · 10 L
Empty beta bags. The EM load is set by the monitoring plan: which plates, how many, which swabs, which sampler head. It changes with the session and the location, so the bag is loaded by your team. The Empty line is available in every variety, volume and port option. The Pre-loaded line, where we load components in our ISO Class 7 cleanroom, is for recurring, identical kits such as closures for a filling line.
indB, gamma sterile. indB is supplied pre-sterilised by gamma irradiation at 25–40 kGy to a sterility assurance level of 10⁻⁶, with dosimetric release per batch, and needs no preparation. That matters twice for EM. The plates and swabs are sterile consumables that cannot go through an autoclave cycle with the bag, so a bag that is sterile on arrival is the one that can be loaded with them. And a QC laboratory rarely runs its own cycle for transfer bags; a ready-to-use bag with a 2-year shelf life from manufacture suits a stock that is drawn from daily. indA, autoclavable with a 3-year shelf life, is the choice only where the load can take a 121 °C cycle and the team wants control over timing.
10 L. One session's plates, swabs and a sampler head fit a 10 L bag, with a useful volume of 10 L, and still lie flat. The flat pouch hangs against the isolator wall, which keeps the plates in the orientation they were loaded in. Choose 25 L when a session's load is larger, for example when the consumables for several sampling locations are brought in at once. The load limit for each volume is shown with the configuration in Build Your Bag. Store unopened bags at 13–27 °C and 30–60 % relative humidity, away from sunlight, ozone and heat.
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 an EM application the per-batch cleanliness data and the gamma release matter most: the CoA records the batch tests, and each indB batch is released dosimetrically. On request:
- the extractables summary
- the validation package, under MNDA
Gamma compatibility of the bag is verified to 40 kGy, and the sterility audit for indB looks for no growth over 14 days. 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. For the EM record itself, the lot on the overwrap and the QR-coded GTIN on the carton give each transfer a bag identity that can be written against the sample.
How a transfer runs
The operator brings the loaded 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 plates and swabs are taken out and placed, and the door closes. The bag turns back and comes away with its cover sealed again. At the end of the session the sequence runs in reverse: a bag docks, the exposed plates go in, the door closes, and the bag leaves the port as a closed sample container. The multi-cycle docking method accepts up to 5 dockings per bag.
Which variety for this use?
For environmental monitoring and sampling, DeltaQuant recommends an Empty beta bag, variety indB, 10 L: sterile on arrival, loaded by your QC team, docked for the way in and the way out. Choose indA only where the load can be autoclaved with the bag, and 25 L for larger sampling 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. The related page on cleanroom staging covers the bags prepared ahead of the campaign.