Single-Use Bioprocessing Bags — GMP-Compliant, No Minimum Order, EU Delivery
Your production run is in three weeks. Supplier A from the US: 6–12 weeks lead time. Supplier B from Sweden: minimum one pallet. Supplier C from the US: request a quote first, 5 business days. SeamlessBio supplies 2D and 3D bioprocessing bags from EU stock — no MOQ, full GMP documentation, 2–5 business days to DACH.
Large suppliers build their logistics for commercial-scale manufacturing — not for your 15-litre pilot run. SeamlessBio exists for exactly that gap: GMP-documented 2D bags (50 mL–50 L) and 3D bags (50 L–3,000 L) from EU stock, no minimum order, 2–5 business-day delivery across DACH and EU. Full documentation included as standard.
2D and 3D Bags — Which Do You Need?
The format determines the application. Choosing wrong means process incompatibilities and validation rework.
| Format | Primary Use | Lautstärkebereich | Typical Application |
|---|---|---|---|
| 2D Bag (pillow bag) | Media/buffer storage, mixing, transfer, chromatography feed | 50 mL – 50 L | Buffer hold, media prep, intermediate product hold, harvest collection |
| 3D Bag (cube bag) | Large-volume storage, bulk transfer, intermediate hold | 50 L – 3,000 L | Upstream/downstream fluid handling, chromatography feed, cold storage |
Who Calls Us — and Why
ATMP Manufacturers (CAR-T, Gene Therapy, MSC)
A CAR-T team needs 8 bags for a Phase I batch. Supplier A from the US quotes 8 weeks. That’s the moment they call us. Clinical ATMP processes run in small batches — SeamlessBio supplies single-unit quantities with full GMP documentation: USP Class VI certification, BPOG-aligned extractables data, ISO 11137 gamma irradiation certificate. No account setup, no pallet minimum.
Contract Research Organisations (CROs)
Three parallel client studies, three different bag volumes, two different port configurations — and procurement wants one vendor. A CRO covering 50 mL through 3,000 L from a single EU source, with per-lot CoA and project-specific documentation, removes the multi-vendor coordination problem entirely.
Vaccine Manufacturers — Pilot Scale
Pilot batches for clinical trials need the same documentation as commercial production. The difference is volume. Supplier B from Sweden doesn’t ship below one pallet. SeamlessBio does — with full lot traceability, biocompatibility docs and delivery within the week.
GMP Documentation — What Comes With Every Order
Regulatory submissions require material documentation. SeamlessBio provides this as standard — not on request, not at extra cost.
- Certificate of Analysis (CoA) — lot-specific, per batch
- USP <87> / USP <88> Class VI biocompatibility certification
- ISO 10993 compliance documentation; USP <85> / USP <661>
- Gamma irradiation certificate (ISO 11137, SAL 10⁻⁶); double-bag irradiation-verified packaging
- BPOG-aligned extractables data (on request)
- ISO Class 7 cleanroom manufacturing declaration
- BSE/TSE-free declaration
- Material Safety Data Sheet (MSDS/SDS)
| Material Specification | Detail |
|---|---|
| Film material | RENOLIT 9101 multilayer: ULDPE/LLDPE fluid contact layer · EVOH gas barrier · tie layers · outer protective PE layer |
| Biocompatibility | USP <87> / USP <88> Class VI; ISO 10993 compliant; USP <85> / USP <661> |
| Extractables | Controlled extractables profile; BPOG-aligned extractables data available on request |
| Sterilisation | Gamma-irradiated (ISO 11137), SAL 10⁻⁶; double-bagged; ready-to-use |
| Manufacturing | ISO Class 7 cleanroom; 100% visual inspection and leak testing; full lot traceability with CoA |
| Ports (2D) | PCS or TPE tubing; luer-lock (male/female), 3/8″ male insert, AseptiQuick G, end plug — configurable per SKU |
| Ports (3D) | 3/8″ or 1/2″ PCS/TPE tubing; male insert, AseptiQuick G, luer-lock, end plug — 2-port or 3-port layouts |
| Compliance | EU GMP Annex 1; EMA ATMP Regulation (EC) No 1394/2007 documentation ready |
Häufig gestellte Fragen
What is the minimum order quantity for single-use bags?
There is no minimum order at SeamlessBio. You can order a single bag or a single pallet — same pricing structure, same documentation. This is specifically designed for ATMP manufacturers and clinical-phase biopharma who cannot absorb large inventory commitments.
How quickly are bags delivered to Germany, Austria, and Switzerland?
Standard delivery from EU stock: 2–4 business days to Germany and Austria; 3–5 days to Switzerland (export documentation included). Express delivery available on request. Contact us for your specific location and volume.
Can I order custom bag configurations — specific port types or sizes?
Yes. Custom port configurations, tubing sets, and non-standard volumes are available with a minimum lead time. Contact SeamlessBio with your process requirements — we coordinate with the manufacturer for custom assemblies while providing standard items from EU stock.
Are the bags compatible with Sartorius, Cytiva, and other bioreactor platforms?
Compatibility depends on the specific bioreactor system and bag holder geometry. Contact us with your bioreactor model — we confirm compatibility or recommend the correct bag geometry and port configuration before you order.
What documentation is required for an ATMP regulatory submission?
For EMA ATMP submissions under Regulation (EC) No 1394/2007, starting material documentation for single-use containers typically requires: USP Class VI certification, gamma irradiation certificate, extractables data, and BSE/TSE declaration. All of these are available from SeamlessBio as standard with each lot.
Request a Quote or Order Directly
Tell us your bag type, volume, port configuration, and required documentation. We respond within 24 hours.
View Bag Portfolio Request a Quote
English 
Deutsch