Beta bags for sterile API powder bring the active ingredient to the point where it is needed, inside an isolator or a closed RABS, without exposing it to the room or the room to it. The DELTAQUANT 190 mm single-use beta bag from DeltaQuant Lifesciences FZE is a flat pouch with a rigid beta flange sandwiched into its face; it docks to industry-standard 190 mm alpha ports and opens only into the closed process. This page describes the transfer problem with sterile powder, how the bag solves it, which line, variety and volume fit, and what QA receives with every batch.
The use case: sterile powder into a closed process
A sterile active pharmaceutical ingredient is made under aseptic conditions, dried and sealed in a primary container, and later dispensed or dissolved inside a closed process: a compounding isolator, a powder-filling line, a formulation suite under RABS. Between those two points the material has to cross at least one sterile boundary. Unlike a sealed vial, a powder cannot be surface-decontaminated and passed through an airlock: the container can, the contents cannot, and any transfer that opens the container outside the closed zone exposes the product.
The transfer therefore has to carry the primary container, still closed, into the isolator, where it is opened and the powder handled under Grade A conditions. The same path is used in reverse for sample containers and for the empty primary container that leaves the zone after dispensing.
The transfer problem
Three things make powder transfers demanding. The first is sterility: whatever carries the container into the isolator must be sterile on its inside, so that nothing is introduced with it. The second is repeatability: dispensing runs in lots, and a transfer that depends on a decontamination cycle each time becomes the bottleneck of the process. The third is traceability: QA needs to show that the transfer device was released to defined limits, batch by batch, with the documentation to prove it.
The DELTAQUANT beta bag is specified as an aseptic transfer device. Whether a given transfer also meets your occupational exposure requirement for a potent compound is assessed with your engineering team per application; no figure for it is published here.
How beta bags for sterile API powder solve it
The single-use beta bag is the beta half of an alpha-beta rapid transfer port. The alpha port sits in the isolator wall with its own door; the bag arrives with its own sealed cover. The primary container of API, in its outer packaging or as supplied from the sterile manufacturing step, is placed in the pouch in your process, the pouch is sealed, and the bag goes to the port. Docked and locked, the alpha door and the beta cover become one plate; the surfaces that were outside are held together while the plate swings inward, and the container passes into the isolator through an opening that was never exposed to the room.
The beta flange is Ø 190 ± 0.4 mm, compatible with industry-standard 190 mm alpha ports, in a Standard version and an Interlock-chamfer (IC) version for chamfered alpha ports. The pouch has two faces: a clear, impervious multilayer LLDPE film and a white Tyvek® flash-spun HDPE microbial barrier, welded together around the edge; the barrier face is tested to ASTM F1608 with LRV ≥ 4 as the acceptance criterion. Each bag is supplied in a double-bag configuration, overwrapped and tamper-evident sealed, and is rated for up to 5 dockings, so a bag that carried a container in can carry a sample out of the same campaign.
How a transfer runs
The operator brings the pouch to the port flange-face forward, flat and parallel to the isolator wall. The flange bayonets engage the alpha port; a short turn locks the bag, and the alpha door and the beta cover join into one plate. From inside the isolator the gloved operator swings the joined door inward, lifts the container out of the pouch and closes the door, which re-seals. The bag is turned back and comes away with its cover sealed again. Throughout, the pouch hangs flat against the wall, held by the flange, with the long part below the flange and the short part above it.
Line, variety and volume for sterile API powder
The recommended configuration is Empty · indB · 10 L.
- Empty beta bags. The primary container of API is yours and is placed in the bag in your own process, so the Empty line is the right one: a ready-to-use transfer bag available in every variety, volume and port option. The Pre-loaded line is for components we load in our ISO Class 7 cleanroom, such as stoppers and seals; both lines are set out on the Products page.
- indB, gamma sterile. Supplied pre-sterilised by gamma irradiation at 25–40 kGy to SAL 10⁻⁶, released dosimetrically per batch, with a 2-year shelf life and no preparation. Many API containers are not meant to go through a steam cycle, so a bag that is already sterile inside is what the transfer needs: load, seal, dock. Choose indA, autoclavable, only where the primary container tolerates your validated autoclave cycle (121 °C for 30 min, one cycle) and you want bag and container sterilised together; indA keeps for 3 years from manufacture.
- 10 L. A 10 L pouch takes the usual API containers one at a time, and the smaller pouch is easier to hold flat at the port and to handle with gloves inside the isolator. Take 25 L for larger containers or several containers in one docking. Both volumes carry the same 190 mm beta port. Respect the load limit of the volume you choose; the figure for each volume is shown with the configuration in Build Your Bag.
What QA receives
Every batch ships with a CoA and a CoC. Behind them: a 100 % flange leak test by pressure decay (5 in. H₂O over 60 s), 100 % visual inspection, dimensional inspection to AQL 0.65, and per-batch bioburden (ISO 11737-1, ≤ 1000 CFU/bag), endotoxin (USP <85>, < 0.25 EU/mL), particulates (USP <788>, ≥ 10 µm ≤ 20/mL and ≥ 25 µm ≤ 3/mL) and weld strength (ASTM F88, ≥ 5.0 lbf/in). The bag is non-fiber-releasing (21 CFR 210.3(b)(6)). Methods and acceptance criteria for every test are listed on the Proof page; measured values appear there once a batch report carries them.
For a product-contact assessment the extractables summary is available on request, together with the validation package under MNDA, load-pattern guidance, and for indA the autoclave compatibility statement and post-autoclave inspection protocol. Contact materials are high-temperature polycarbonate, platinum-cured silicone, HDPE and multilayer LLDPE, with USP <87> / <88> Class VI, ISO 10993-1, Ph. Eur. 3.1.5, BSE/TSE (EMA/410/01) and REACH / RoHS positions on the documentation desk. In normal use the powder stays in its primary container and does not touch the bag. Store the bags at 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat.
Which variety for this use?
For sterile API powder into a closed process, Empty · indB · 10 L: a gamma-sterile bag you load with the closed primary container in your own process, docked to a standard or interlock-chamfer 190 mm alpha port, up to 5 dockings per bag, nothing to prepare. Choose indA where container and bag are autoclaved together. Choose 25 L for larger or multiple containers. Custom sizes are made on request after an engineering review. Request samples for sterile API powder to check the fit on your own port, configure the bag in Build Your Bag, or read Autoclave vs gamma: choosing a beta bag if the variety is still open.