Beta bags for aseptic waste removal take what a campaign leaves behind, used stoppers, rejected vials, filter housings, wipes, empty component wraps and sampling consumables, out of the isolator through the alpha port, so that the waste path is as closed as the material path in. DeltaQuant Lifesciences FZE supplies the DELTAQUANT 190 mm single-use beta bag for this use as an Empty beta bag: you load it from inside the isolator, in your process, and it leaves with its cover re-sealed. This page describes the use case, the transfer problem and the configuration we recommend for it.
The use case: waste out of a closed isolator
Every isolator produces waste while it runs. A filling isolator accumulates rejected containers, used stoppers from a change of format, the packaging that components arrived in, environmental monitoring consumables and the wipes from a glove-port intervention. A containment isolator around a potent material produces the same, with the added rule that nothing inside may reach the operator or the room. In both cases the waste has to leave while the campaign continues, and it has to leave without opening the barrier. In practice it is often the most frequent transfer on the line, and the one with the least attention paid to it.
The transfer problem
Taking waste out through the same hatch that sterile material comes in is the weak point. The hatch or the airlock has to be decontaminated after every pass, the waste sits in the lock exposed to the room, and the inbound flow stops while it does. Waste is bulky and irregular, and broken glass and used filter housings are heavier and sharper than the components that came in. An outbound path therefore needs three things: a boundary that stays closed on both sides, a pouch with enough volume and a tough enough film for a full shift's waste, and a bag that leaves with its contents and is never reprocessed.
Beta bags for aseptic waste removal on a 190 mm alpha port
A single-use beta bag turns the waste path into a closed transfer in the outbound direction. The DELTAQUANT bag is a flat pouch with the rigid 190 mm beta flange sandwiched into its face: a clear film face on one side, a white Tyvek® flash-spun HDPE microbial barrier face on the other, welded together around the edge, with the flange mounted into the face at the lower middle of the pouch. The flange cover docks to the alpha port, a short turn locks it, and the alpha door and the beta cover open together as one plate. Waste goes through the open port into the pouch, which hangs flat against the isolator wall below the port. When the door closes and the bag is turned back, the cover re-seals and the bag comes away closed, with the waste inside and the outer faces of both doors never exposed to the inside.
The flange is made to Ø 190 ± 0.4 mm and is compatible with industry-standard 190 mm alpha ports; an interlock-chamfer (IC) version exists for chamfered alpha ports. A waste bag normally docks once and leaves full, but the bag is designed for up to 5 dockings, so a part-filled bag can be removed and docked again later in the shift. 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 bag that leaves the line can be traced back to its batch.
Which line, variety and volume
We recommend Empty · indA · 25 L for this application.
- Empty beta bags. An Empty beta bag is a ready-to-use transfer bag the customer fills in their own process; for this use the filling happens from inside the isolator. It is available in every variety, volume and port option. Nothing is loaded by us and nothing has to be agreed per kit: you load the bag from inside the isolator, and it leaves with its contents. See both lines side by side on the Products page.
- indA, autoclavable. The bag is supplied non-sterile and autoclaved by the customer in one validated cycle at 121 °C for 30 min, with a steam indicator dot (ISO 11140-1 Class 1) on the bag. Sites that run an isolator usually already autoclave their consumables, so an indA waste bag goes through the same cycle, on the site's own timing, from stock with a 3-year shelf life. The guidance for the cycle: lay the bag flat, porous face down; run at 121–123 °C, since 124 °C or more may damage the bag; keep the vacuum ramp at or below 0.5 bar/min; respect the load limit; one cycle only; the customer validates the cycle.
- Why not indB for this use. indB arrives gamma sterile and needs no preparation, which is the right choice when the bag's interior has to be ready to receive sterile components. A waste bag receives waste; what matters is the closed interface and the film, not a pre-sterilised interior, so the autoclavable variety, run through the cycle the site already uses, is the fit. indB remains available for sites without an autoclave; the two routes are compared in Autoclave vs gamma: choosing a beta bag.
- 25 L. Waste is bulky, so the larger useful volume means fewer bags and fewer dockings per shift. The 10 L version suits short runs and small isolators. The load limit for each volume is shown with the configuration in Build Your Bag; a bag of sharps or glass should be loaded well inside it.
Set this configuration up in Build Your Bag: Empty · indA · 25 L. Custom sizes are made on request after an engineering review.
What the documentation set gives QA
Every batch ships with a CoA and a CoC. On request we provide the autoclave compatibility statement for indA, the post-autoclave inspection protocol, load-pattern guidance for the autoclave, an extractables summary and the validation package under MNDA. For a waste bag the type tests QA tends to look at first are the ones that describe a loaded, docked pouch: weld peel strength (ASTM F88, acceptance ≥ 5.0 lbf/in), burst (ASTM F1140, ≥ 18 kPa), film tensile and elongation (ASTM D882, ≥ 25 MPa and ≥ 300 %), transit and drop (ASTM D4169, no damage), seal dye penetration (ASTM F1929, no penetration) and steam compatibility for indA (no damage after one cycle). The microbial barrier of the porous face is tested to ASTM F1608 with an acceptance of LRV ≥ 4, and alpha-port docking is tested in-house with the criterion of no barrier loss.
Release testing covers a 100 % flange leak test by pressure decay (5 in. H₂O / 60 s), 100 % visual inspection, dimensional inspection at AQL 0.65 and per-batch testing of bioburden, endotoxin, particulates and weld strength. The cleanliness limits are bioburden ≤ 1000 CFU/bag (ISO 11737-1), endotoxin < 0.25 EU/mL (USP <85>), particulates ≥ 10 µm ≤ 20/mL and ≥ 25 µm ≤ 3/mL (USP <788>) and non-fiber-releasing per 21 CFR 210.3(b)(6). The full list of methods and acceptance criteria, and the request link for each document, is on the Proof & Documents page. Storage before use: 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat.
How a transfer runs
The operator brings the autoclaved bag to the port flange-face forward, the pouch flat and parallel to the isolator wall. The bayonets on the flange engage the alpha port and a short turn locks the bag; the alpha door and the beta cover become one plate. From inside the isolator the joined door swings inward and the waste is passed through the open port into the pouch, which hangs below the flange against the wall. The door closes, the bag turns back and comes away with its cover re-sealed; the sealed pouch goes to the site's waste stream. The isolator has not been opened, and the inbound port is free for the next transfer in.
Which variety for this use?
Empty · indA · 25 L: a bag you load from inside the isolator and autoclave in your own validated cycle, in the volume that takes a full shift's waste in one docking, from stock with a 3-year shelf life. indB is the alternative for sites without an autoclave; 10 L is the alternative for short runs. Both are built the same way and dock on the same industry-standard 190 mm alpha ports. Request samples for aseptic waste removal, or ask for a quotation and sales will reply within one business day.