Beta bags for lyophilisation trays carry the trays, frames and tray tools that a freeze-drying line needs into the loading isolator, and bring them out again, through a 190 mm alpha port with the sterile boundary intact. 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, which suits flat, rigid items better than a round container would. This page covers the transfer problem around a lyophiliser, how the bag solves it, which line, variety and volume fit, and what QA receives.
The use case: loading and unloading a lyophiliser under isolation
In a freeze-dried product, vials are filled, partially stoppered and placed on trays, then moved into the lyophiliser; after the cycle the chamber is vented, the vials are fully stoppered under the shelves and the trays are unloaded. On an isolator-based line the filling, the loading and the unloading all take place in Grade A, and the lyophiliser door opens only into the isolator. The trays themselves, the tray frames, the tray tools and the spare parts of the loading system must therefore reach the isolator sterile and leave it closed, every campaign and sometimes several times within one.
Development and clinical-scale lines have the same need at a smaller scale: a handful of trays go in with the batch, sample vials come out, and the trays return for cleaning. Each movement is an intervention unless it runs through a port.
The transfer problem
Trays are large, flat and rigid. They do not fit the small transfer devices used for stoppers and tools, and they are an awkward load for a pass-box. They are also stainless steel, which means they are cleaned and steam-sterilised anyway, so the useful question is how to get a tray from the autoclave to the inside of the isolator without it ever being exposed in between. A transfer device that can be autoclaved with its contents, and that takes a flat item, closes that gap.
How beta bags for lyophilisation trays solve it
The single-use beta bag is the beta half of an alpha-beta rapid transfer port. The trays are loaded into the pouch in your preparation area, the pouch is sealed, and bag and trays go through your validated autoclave cycle as one unit. Afterwards the sealed bag is brought to the alpha port in the isolator wall. 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 trays pass into the isolator through an opening that was never exposed to the room. Used trays, frames and sample vials leave the same way, in a fresh bag or, within the rating, in the same one.
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 what lets steam in and out during the cycle and 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.
How a transfer runs
The operator brings the pouch to the port flange-face forward, flat and parallel to the isolator wall; with a tray inside, the pouch is held by the flange and the weight hangs below it. The flange bayonets engage the alpha port and a short turn locks the bag; the alpha door and the beta cover are now one plate. From inside the isolator the gloved operator swings the joined door inward, slides the tray out of the pouch onto the loading table, and closes the door, which re-seals. The bag is turned back and comes away with its cover sealed again. The pouch stays flat against the wall throughout, the long part below the flange and the short part above it.
Line, variety and volume for lyophilisation trays
The recommended configuration is Empty · indA · 25 L.
- Empty beta bags. The trays are yours and are loaded in your own process, so the Empty line is the right one: a ready-to-use transfer bag in every variety, volume and port option. Both lines are described on the Products page.
- indA, autoclavable. Supplied non-sterile and autoclaved by you, with its contents, in one validated cycle: 121 °C for 30 min, the chamber within 121–123 °C, since 124 °C or more may damage the bag; a vacuum ramp no faster than 0.5 bar/min; the bag laid flat with the porous face down; the load limit respected; one cycle only. A steam indicator dot (ISO 11140-1 Class 1) on the bag serves as the process indicator that it has been through the cycle. The bag keeps for 3 years from manufacture. Because the trays have to be steam-sterilised in any case, indA turns two steps into one. Choose indB, gamma sterile, when the trays arrive sterile by another route or no autoclave is available at the line: it is supplied pre-sterilised at 25–40 kGy to SAL 10⁻⁶, released dosimetrically per batch, with a 2-year shelf life.
- 25 L. The larger pouch gives the length and width a tray needs, and the flat pouch shape keeps the tray parallel to the wall at the port. Take 10 L for tray tools, spare parts and sample vials. 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). Steam compatibility of indA is checked by an in-house method with no damage after one cycle as the acceptance criterion. Methods and criteria for every test are listed on the Proof page; measured values appear there once a batch report carries them.
Three documents on request matter most for this use: the autoclave compatibility statement (indA); the post-autoclave inspection protocol, which tells the operator what to check on the bag after the cycle and before it goes to the port; and the load-pattern guidance for placing bags in the chamber. The extractables summary and the validation package under MNDA complete the set. Contact materials are high-temperature polycarbonate, platinum-cured silicone, HDPE and multilayer LLDPE, with USP <87> / <88> Class VI, ISO 10993-1, BSE/TSE (EMA/410/01) and REACH / RoHS positions on the documentation desk. Store the bags at 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat, and count the shelf life from the date on the carton.
Which variety for this use?
For lyophilisation trays, Empty · indA · 25 L: a bag you load with the trays and autoclave with them in your own validated cycle, then dock to a standard or interlock-chamfer 190 mm alpha port, up to 5 dockings per bag. Choose indB when the trays are already sterile or there is no autoclave at the line. Choose 10 L for tools and sample vials. Custom sizes are made on request after an engineering review. Request samples for lyophilisation trays to check the fit and the load on your own port, configure the bag in Build Your Bag, and read How many dockings can a beta bag take? before planning a multi-docking campaign.