SeamlessBio – Einweg-Bioprozesse

Single-Use Bag Assemblies

Pre-assembled, gamma-sterilised bioprocess bag assemblies — 2D flat bags and 3D formed bags, complete with tubing, port manifolds and filters for fully closed, GMP-compliant fluid management. 10 mL to 2000+ L. Custom configurations available. EU and UK supply via SeamlessBio.

2D-Taschen 10 mL – 50 L

3D-Taschen 50 L – 2000+ L

Sterilisation Gamma · SAL 10⁻⁶

Material USP-Klasse VI

Cleanroom ISO Class 10K

Angebot anfordern Im Shop ansehen

What is a single-use bag assembly? A pre-configured, sterile system combining a flexible bioprocess bag with tubing, connectors and optional filters — gamma-sterilised (SAL 10⁻⁶), USP Class VI, ISO 10K cleanroom, ready to use without cleaning or sterilisation validation. Two main formats: 2D flat bag assemblies (~10 mL–50 L) for buffer/media prep, sampling and rocker bioreactors — and 3D formed bag assemblies (50 L–2000+ L) for large-scale cell culture, fermentation and bulk mixing.

2D vs 3D Single-Use Bag Assemblies

Choose the right format for your volume range and bioprocess step — both are gamma-sterilised, USP Class VI and configurable with custom tubing, connectors and filters.

2D Flat Bag Assembly

2D Single-Use Bag Assembly

Flat, pillow-style bioprocess bag assemblies for small to medium volumes — the standard format for buffer and media preparation, seed train expansion, sampling and rocker / wave bioreactor applications.

Volume range: ~10 mL – 50 L
Flat / pillow-style bag format
Bag film: PE, LDPE, EVA multi-layer
Compatible with rocker / wave bioreactors
Connectors: HB 1/8″ & 1/4″, MPC, Luer, AQG
Optional: 0.2 µm PTFE vent filter, sampling port
Tubing: silicone or TPE (sterile weld-compatible)
Gamma-sterilised · Ready to use

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Large Scale 3D Formed Bag Assembly

3D Single-Use Bag Assembly

Three-dimensional, structurally formed bioprocess bag assemblies for large-scale manufacturing — supported in stainless-steel tray or rigid container systems for stirred-tank and bulk mixing processes.

Volume range: 50 L – 2000+ L
3D / cube-formed bag format
Requires SS tray or rigid container support
For stirred-tank bioreactors and large mixing
Connectors: Tri-Clamp, MPC, HB, sanitary
Optional: dip tubes, sensors, multi-port manifolds
Tubing: silicone or TPE, custom lengths
Gamma-sterilised · Ready to use

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2D vs 3D Bag Assembly — Full Comparison

Spezifikation	2D Bag Assembly	3D Bag Assembly
Volume range	~10 mL – 50 L	50 L – 2,000+ L
Bag format	Flat / pillow-style	Three-dimensional / cube-formed
Support structure	None (lies flat on tray)	SS tray or rigid container
Primary applications	Buffer/media prep, sampling, seed train, fluid transfers	Large-scale cell culture, fermentation, bulk mixing
Rocker bioreactor compatible	✓ (10 L / 20 L / 50 L)	—
Stirred-tank bioreactor	—	✓
Standard connectors	HB 1/8″ & 1/4″, MPC, Luer, AQG	Tri-Clamp, MPC, HB, sanitary
Optional components	0.2 µm PTFE vent, sampling port	Dip tube, sensors, multi-port manifolds
Gamma-sterilised	✓ SAL 10⁻⁶	✓ SAL 10⁻⁶
USP-Klasse VI	✓	✓
ISO Class 10K cleanroom	✓	✓
TSE/BSE-free	✓	✓
Custom configurations	✓ Auf Anfrage	✓ Auf Anfrage
Ready to use (no CIP/SIP)	✓	✓

What's inside a single-use bag assembly?

Every SeamlessBio bag assembly integrates all required components into a single, pre-sterilised system — no in-house assembly, no sterility risk, no validation effort. The core components are:

Bag film — medical-grade multi-layer film (PE, LDPE, EVA copolymers) with high O₂/CO₂ gas barrier and full biocompatibility. TSE/BSE-free, endotoxin-free, tested per USP <788>.

Schläuche — medical-grade silicone or TPE (thermoplastic elastomers), sterile-weld compatible for fully closed connections. Custom diameters and lengths available. USP Class VI.

Connectors & fittings — MPC/MPX couplings, Luer Lock, Hose Barb (1/8″ & 1/4″), AQG, Tri-Clamp and needle-free sampling ports. Compatible with all standard bioprocess platforms.

Optional components — 0.2 µm PTFE vent filters, sterilising-grade PES filters, dip tubes, pressure sensors and multi-line manifold assemblies — all pre-integrated and gamma-sterilised.

For applications requiring 2D bag assemblies connected directly to rocker bioreactors, see our Single-Use Rocker Bags — same USP Class VI standard, pre-validated connector combinations.

Typische Anwendungsbereiche

Buffer and media preparation (upstream)
Seed train and inoculum expansion
Rocker / wave bioreactor operation (2D bags)
Large-scale cell culture and fermentation (3D bags)
Downstream filtration feed and hold
Aseptic fluid transfer between vessels
In-process sampling (needle-free port)
ATMP / cell therapy closed-system processing
Virus vector production (AAV, lentiviral)
Vaccine manufacturing (CHO, Vero cell)
Freeze-thaw bulk drug substance storage (2D)
Chromatography buffer management

Quality documentation available on request

Certificates of conformity, batch records and material documentation are available for each bag assembly configuration. Contact us for details specific to your application and regulatory requirements.

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Single-Use Assemblies — Full Portfolio

Beyond bag assemblies, SeamlessBio supplies the full range of single-use assemblies for biopharma fluid management — all configurable on request.

Bioprocess Bag Assemblies 2D flat bags (10 mL–50 L) and 3D formed bags (50 L–2000+ L) with tubing, connectors and filters — this page.

Flask Assemblies Single-use Erlenmeyer flask assemblies (125 mL–5 L) with vented caps, HB connectors and sterile tubing sets for cell culture and media prep.

Bottle & Carboy Assemblies Sterile bottle and carboy assemblies with multi-port closures (1–3 ports), tubing and connectors for buffer handling and downstream storage.

Tubing & Fluid Transfer Sets Custom tubing assemblies in silicone, TPE or C-Flex — sterile-welded, connector-terminated fluid transfer sets for closed-system processing.

All assemblies are gamma-sterilised and manufactured from materials suitable for biopharma applications. Exact specifications and available certifications on request.

Used by

ATMP Manufacturers

CDMOs & CROs

Vaccine Producers

Cell Therapy Labs

Biopharma CMOs

Biotech R&D

Academic Bioprocessing

Diagnostics Companies

Häufig gestellte Fragen

A single-use bag assembly is a pre-configured, gamma-sterilised system combining a flexible multi-layer bioprocess bag with tubing, connectors (MPC/MPX, Luer, Hose Barb), optional filters and sensors — ready to use without cleaning or sterilisation validation. Two main formats: 2D flat bag assemblies (10 mL–50 L) and 3D formed bag assemblies (50 L–2000+ L).

2D bag assemblies are flat, pillow-style bioprocess bags (~10 mL–50 L) for buffer/media preparation, sampling and rocker bioreactors. 3D bag assemblies are three-dimensionally formed, tray-supported bags (50 L–2000+ L) for large-scale cell culture, fermentation and bulk mixing. Both are gamma-sterilised (SAL 10⁻⁶) and USP Class VI compliant.

Yes. SeamlessBio bag assemblies are manufactured in ISO Class 10K cleanrooms, gamma-sterilised to SAL 10⁻⁶ and produced from USP Class VI materials — ready to use directly, with no cleaning or sterilisation validation required. Full GMP documentation (batch records, CoC, E&L test reports) is available on request.

Standard tubing options include medical-grade silicone, thermoplastic elastomers (TPE) and C-Flex — all compatible with sterile tube welding. Custom diameters, wall thicknesses and lengths are configured on request. All tubing is USP Class VI compliant and gamma-sterilised.

All standard bioprocessing connectors are available: MPC/MPX couplings, Luer Lock, Hose Barb (1/8″ & 1/4″), AQG, Tri-Clamp sanitary fittings and needle-free sampling ports. We configure the optimal connector combination for your specific bioprocess equipment and bag port standard.

Yes. SeamlessBio 2D bag assemblies (10 L, 20 L, 50 L) are directly compatible with rocker / wave bioreactor bags. Tubing sets and manifolds connect via sterile tube welding or HB connectors, enabling closed-system media addition, sampling, harvest and waste removal without sterility break.

Yes. We configure both 2D and 3D bag assemblies to your exact requirements: bag film type and volume, tubing material and length, port count, connector type, optional 0.2 µm PTFE vent filter and sampling ports. Contact SeamlessBio for a consultation and custom quote — fast delivery to EU and UK.

Request a Quote for Your Bag Assembly

2D bags (10 mL–50 L) or 3D bags (50 L–2000+ L) — custom configurations with tubing, connectors and filters. Full GMP documentation. Fast EU and UK delivery via SeamlessBio.

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Single-Use Assembly