3D Bioprocessing Bags
Cubic, freestanding single-use bags for large-volume storage, bulk transfer and upstream/downstream fluid handling — 100 litres to 1,000 litres. RENOLIT 9101 film, gamma-sterilised, ISO Class 7 cleanroom. Full GMP documentation. EU stock, 2–5 business days to DACH.
Buy single-use bioprocessing bags from EU stock
Request a quote or a sample – stocked in Germany, gamma irradiated 25–45 kGy, full GMP documentation, batch reservation up to 36 months.
3D bioprocessing bags are cubic, freestanding single-use containers for large-volume fluid handling in biopharmaceutical manufacturing. SeamlessBio supplies them from EU stock in volumes from 100 litres to 1,000 litres — RENOLIT 9101 multilayer film, certified to USP <87>/<88> Class VI, gamma-sterilised (ISO 11137, SAL 10⁻⁶), ISO Class 7 cleanroom. No minimum order. Full GMP documentation with every lot.
100 L to 1,000 L
Pilot scale through commercial production — one supplier, one documentation package, one contact for the full volume range.
RENOLIT 9101 Film
ULDPE/LLDPE fluid-contact layer, EVOH gas barrier, outer PE. USP <87>/<88> Class VI certified, ISO 10993 compliant. Controlled extractables profile.
Freestanding Geometry
Cubic design sits in standard stainless-steel support frames and cages. Stable footprint for bulk fluid hold, cold storage and large-volume chromatography feed.
2- and 3-Port Layouts
3/8" and 1/2" PCS/TPE tubing; male insert, AseptiQuick G, luer-lock, end plug — standard and custom configurations available.
Where 3D bags fit in your process
3D bioprocessing bags — also called cube bags — are the single-use container of choice wherever large volumes need to be stored, transported or transferred cleanly in a biopharmaceutical process. Their freestanding, cubic geometry allows them to sit in standard stainless-steel support frames or custom cage systems, making them a direct replacement for rigid tanks in buffer hold, bulk product storage and large-volume chromatography feed applications.
Unlike 2D pillow bags, 3D bags do not require a flat surface or rocking platform — they stand independently once filled. This makes them practical for GMP buffer suites, cold rooms and large-scale downstream processing areas where floor space is managed carefully.
SeamlessBio 3D bags use the same RENOLIT 9101 film platform as the 2D range — same certifications, same extractables documentation, same GMP documentation package. This simplifies supplier qualification when both formats are used in the same facility.
Typical applications
- Large-volume buffer hold (equilibration, wash, elution)
- Bulk product intermediate storage pre-/post-chromatography
- Chromatography column feed — large-scale loading and elution
- Upstream media hold for large bioreactor runs
- WFI and purified water hold for buffer preparation
- Cold storage of purified bulk drug substance
- Viral vector manufacturing — upstream fluid handling (AAV, lentiviral)
- mRNA process — buffer and reagent hold at scale
- Vaccine production — pilot and commercial batch fluid handling
- TFF/UF hold tank replacement — single-use retentate and permeate hold
Material specification and certifications
SeamlessBio 3D bags are manufactured from RENOLIT 9101 multilayer film — a controlled-extractables platform used across regulated biopharmaceutical manufacturing in Europe and the US. The same film is used in both the 2D and 3D ranges, allowing a single extractables data package to cover both formats in a supplier qualification dossier.
| Property | Specification |
|---|---|
| Film material | RENOLIT 9101 multilayer — ULDPE/LLDPE fluid-contact layer · EVOH gas barrier · tie layers · outer protective PE layer |
| Volume range | 100 litres – 1,000 litres (3D / cube format) |
| Biocompatibility | USP <87> cytotoxicity; USP <88> Class VI biological reactivity; ISO 10993 compliant |
| Chemical resistance | USP <85> particulate matter; USP <661> plastics — compliant |
| Extractables | Controlled extractables profile; BPOG-aligned extractables data available on request |
| Sterilisation | Gamma irradiation, ISO 11137, SAL 10⁻⁶; double-bagged; ready-to-use from packaging |
| Manufacturing environment | ISO Class 7 cleanroom; 100% visual inspection; 100% leak testing; full lot traceability |
| BSE/TSE status | BSE/TSE-free declaration included with each lot |
| Regulatory readiness | EU GMP Annex 1 compatible; EMA ATMP Regulation (EC) No 1394/2007 documentation ready |
Port configurations — 3D bags
3D bags are typically supplied in 2-port or 3-port configurations. Port selection determines connection to pumps, sensors, filters and downstream equipment. Standard configurations are in EU stock; non-standard assemblies are sourced with a 3–5 week lead time.
3/8" Male Insert
Standard high-flow port for bulk fluid transfer and pump connections. The most common configuration for buffer hold and chromatography feed.
1/2" Male Insert
High-flow port for high-volume transfer at commercial scale. Reduces transfer time for 500 L+ volumes. Available in standard 3-port layouts.
AseptiQuick G
Aseptic quick-connector for closed-system integration — sterile connection and disconnection without opening the fluid path to the environment.
PCS Tubing
Polycarbonate-based silicone tubing for peristaltic pump integration. Standard in media hold and large-volume buffer transfer applications.
TPE Tubing
Thermoplastic elastomer tubing — preferred for aggressive buffer formulations and processes using organic solvents or low-pH solutions.
End Plug
Sealed port for unused connections. Maintains sterility during transport and storage of pre-filled or staged bags in cold storage.
Who calls us — and why
Vaccine manufacturers scaling to commercial
A vaccine producer moves from Phase II pilot batches (100–200 L) to Phase III commercial runs (1,000–3,000 L). Supplier A from the US quotes 10 weeks and a pallet minimum. SeamlessBio ships from EU stock — same documentation at 100 L as at 3,000 L, no lead time premium for smaller runs during the scale-up phase.
CDMO downstream processing teams
A CDMO running parallel client programmes needs 500 L buffer hold bags for three different projects in the same week — each with its own CoA, lot documentation and client-specific labelling. One EU supplier, one qualification, delivered on the same day.
mAb manufacturers replacing stainless steel
A biologics manufacturer eliminating stainless-steel buffer prep tanks needs 200 L and 1,000 L 3D bags for buffer hold between chromatography steps. No cleaning validation, no cross-contamination control between batches. Single-use from EU stock with full cleaning validation replacement documentation.
ATMP manufacturers at commercial scale
An advanced therapy manufacturer scaling AAV vector production to 500 L bioreactor runs needs large-volume upstream media hold and harvest collection bags. Clinical-grade documentation for regulatory submission, EU delivery within 5 business days.
GMP documentation — standard with every lot
Regulatory submissions require material documentation. SeamlessBio provides this as standard — not on request, not at extra cost.
- Certificate of Analysis (CoA) — lot-specific
- USP <87> / USP <88> Class VI biocompatibility certification
- ISO 10993 compliance documentation
- USP <85> / USP <661> compliance statement
- Gamma irradiation certificate (ISO 11137, SAL 10⁻⁶)
- ISO Class 7 cleanroom manufacturing declaration
- BSE/TSE-free declaration
- Material Safety Data Sheet (MSDS/SDS)
- BPOG-aligned extractables data — on request
- Batch reservation documentation — on request
3D vs. 2D bags — choosing the right format
3D and 2D bioprocessing bags serve different process steps. The format determines mixing behaviour, storage geometry and volume range. Using the wrong format creates process incompatibilities that require validation rework.
| Criterion | 3D Bag (cube bag) | 2D Bag (pillow bag) |
|---|---|---|
| Volume range | 100 litres – 1,000 litres | 150 mL – 50 litres |
| Geometry | Cubic / freestanding — sits in stainless steel cage or support frame | Flat / pillow — lays on flat surface or hangs |
| Mixing | Paddle or impeller-driven mixing via integrated port; or gravity-fed transfer | Excellent on orbital shakers and rocking platforms |
| Primary use | Large-volume buffer hold, bulk transfer, upstream/downstream integration | Media prep, buffer mixing, intermediate product hold, chromatography feed |
| Typical users | Commercial biopharma, large-scale vaccine production, biologics manufacturing, CDMOs | Clinical ATMP, CROs, process development, pilot vaccine batches |
| Storage | Requires cage/frame infrastructure; cold room compatible | Flat — hangs in use, stacks in storage |
| Film material | RENOLIT 9101 multilayer (same certification basis) | RENOLIT 9101 multilayer (same certification basis) |
3D bag applications — by process step
3D bags are specified wherever large-volume, closed-system containment is needed in a biopharmaceutical process. Key steps where 3D bags replace rigid stainless-steel vessels:
Buffer hold and dispensing
Equilibration, wash and elution buffers prepared and held in 3D bags, dispensed directly to chromatography columns via peristaltic pump. No CIP, no tank cleaning between batches.
Bulk product intermediate hold
Clarified harvest or partially purified intermediate held in 3D bags between process steps. Cold-room compatible, with full closure between steps and lot-specific CoA documentation.
Large-scale chromatography feed
500 L to 3,000 L loading volumes fed from 3D bags to large-scale protein A, ion exchange or mixed-mode columns. Gravity or pump-assisted, closed-system transfer.
TFF retentate and permeate hold
Tangential flow filtration retentate and permeate collected in 3D bags for hold and further processing. Replaces stainless retentate tanks in single-use TFF configurations.
Viral vector upstream media hold
Large-volume media hold for AAV or lentiviral vector production bioreactor runs. GMP documentation for IND/IMPD submissions included as standard.
WFI and purified water hold
Purified water and WFI staged in 3D bags for buffer preparation suites. Closed-system fill, hold and dispense — eliminates open vessel contamination risk at water dispensing.
Frequently asked questions
What is the minimum order quantity for 3D bioprocessing bags?
There is no minimum order at SeamlessBio. You can order a single bag — whether that is a 50 L pilot bag or a 2,000 L commercial-scale container — or a full pallet. Same pricing structure, same documentation, regardless of quantity.
What volume range are 3D bioprocessing bags available in?
100 litres to 1,000 litres in the standard range from EU stock. Custom volumes outside this range are available on request with a production lead time. Contact SeamlessBio with your volume requirement for a stock and lead time confirmation.
What film material is used in SeamlessBio 3D bags?
RENOLIT 9101 multilayer film — the same platform used in the 2D bag range. ULDPE/LLDPE fluid-contact layer, EVOH gas barrier, outer protective PE layer. USP <87>/<88> Class VI certified, ISO 10993 compliant, with a controlled extractables profile. BPOG-aligned extractables data is available on request.
What is the difference between 2D and 3D bioprocessing bags?
2D bags are flat (pillow-style), 150 mL to 50 L, optimised for mixing on rocking or orbital shakers — primarily media prep, buffer mixing and small-volume intermediate hold. 3D bags are cubic and freestanding, 100 L to 1,000 L, for large-volume storage, bulk transfer and chromatography feed in support frames or cage systems. Both use the same RENOLIT 9101 film and carry equivalent GMP certifications.
How quickly are 3D bags delivered in Germany and the EU?
Standard delivery from EU stock: 2–4 business days to Germany and Austria; 3–5 business days to Switzerland (export documentation included). Express delivery available on request. Contact us with your location, volume and required delivery date — we confirm stock availability the same day.
Can 3D bags be used for cold storage?
Yes. 3D bags are cold-room compatible when filled and sealed — suitable for bulk drug substance hold at 2–8°C and freeze-thaw applications where the support frame is designed for temperature cycling. Contact us with your cold storage requirement for material compatibility confirmation.
What documentation is required for ATMP and mAb regulatory submissions?
For EMA ATMP submissions under Regulation (EC) No 1394/2007 and mAb/biologic dossiers under EMA guidelines, single-use container documentation typically includes: USP <88> Class VI certification, gamma irradiation certificate, extractables data, and BSE/TSE-free declaration. All of these are available from SeamlessBio as standard with each lot.
Request a quote or order directly
Tell us your bag volume, port configuration and required delivery date. We respond within 24 hours — with stock confirmation, pricing and delivery date.
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