Description
Product Overview
SeamlessBio 3D Single-Use Bioprocessing Bags are cube-shaped tote bags engineered for large-scale sterile fluid management in upstream and downstream biopharmaceutical manufacturing. Built on a multi-layer PE film with integrated EVOH gas barrier (fluid contact: ULDPE), they are designed as 1:1 compatible replacements for Sartorius Flexel® and Thermo Fisher Hyperforma® systems — fitting directly into existing stainless steel and plastic totes without hardware modification. Pre-configured with MPX (Body/Stem) connectors as standard; fully customised manifold designs available on request. Available from 50 L to 1,000 L, gamma irradiated to SAL 10⁻⁶ (ISO 11137), ADCF, USP Class VI, and ISO 10993 compliant. Manufactured in ISO Class 7 cleanroom conditions and stocked in Germany for EU-wide delivery.
Flexel® is a registered trademark of Sartorius Stedim Biotech. Hyperforma® is a trademark of Thermo Fisher Scientific. SeamlessBio is an independent provider of compatible single-use solutions and is not affiliated with or endorsed by these companies.
Technical Specifications
| Parameter | Specification |
|---|---|
| Volume range | 50 L · 100 L · 200 L · 500 L · 1,000 L |
| Film material | Multi-layer PE with EVOH gas barrier; fluid contact layer: ULDPE |
| Temperature range | −80 °C to +60 °C |
| Main connectors | MPX (Body/Stem) — standard configuration |
| Sampling ports | Luer Lock or Needleless Site |
| Tubing material | Clear weldable TPE or platinum-cured silicone — customer-specified lengths |
| Sterility assurance | Gamma irradiated — SAL 10⁻⁶ (ISO 11137); 25–50 kGy |
| Material compliance | 100% Animal-Derived Component Free (ADCF); USP Class VI; ISO 10993 |
| Manufacturing environment | ISO Class 7 cleanroom |
| Hardware compatibility | 1:1 fit for Sartorius Flexel® and Thermo Fisher Hyperforma® cube totes |
| Shelf life | 24–36 months (unopened) |
| Documentation | CoA, CoO, Leachables/Extractables/Tox Validation Guide — batch-specific |
Applications
| Application | Description |
|---|---|
| Media & buffer hold | Large-volume sterile storage of culture media, buffer solutions, and WFI for bioreactor feeding — eliminates cleaning validation cycles between batches |
| Bioreactor harvest | Secure, sterile collection of cell culture supernatant post-harvest, compatible with MPX connections on harvest manifolds |
| Downstream purification hold | Intermediate product storage between chromatography, filtration, and UF/DF processing steps in GMP purification trains |
| Bulk drug substance storage | Safe, documented hold of bulk drug substance prior to fill-finish; film rated to −80 °C for cryogenic storage configurations |
Available Formats
| Format | Size |
|---|---|
| 3D Cube Bag | 50 L |
| 3D Cube Bag | 100 L |
| 3D Cube Bag | 200 L |
| 3D Cube Bag | 500 L |
| 3D Cube Bag | 1,000 L |
| Custom | On request — volume, connector, tubing, manifold layout |
Key Benefits
Drop-In Compatibility
1:1 fit for Sartorius Flexel® and Thermo Fisher Hyperforma® totes — switch supplier without hardware modification or process re-validation.
Full Documentation
Batch-specific CoA, CoO, and Leachables/Extractables/Tox Validation Guide — from ISO Class 7 GMP manufacturing facilities. Additional regulatory documents on request.
EU & Swiss Supply
Stocked in Germany — fast cold-chain delivery across EU, UK and Switzerland. Custom manifold configurations available with short lead times.
Frequently Asked Questions
Are SeamlessBio 3D bags compatible with Sartorius Flexel® or Thermo Fisher Hyperforma® stainless steel totes?
Yes — SeamlessBio 3D bags are designed as 1:1 form-fit-function replacements for cube-shaped tote systems from Sartorius (Flexel®) and Thermo Fisher (Hyperforma®). The bag dimensions and MPX connector configuration match the standard hardware interfaces, allowing direct drop-in use without modification to existing tote frames or manifold connections. Switching to SeamlessBio typically requires only change-control documentation rather than full process re-validation, though the extent of bridging testing depends on your internal SOPs and the regulatory submissions that reference the bag. SeamlessBio is an independent supplier and is not affiliated with or endorsed by Sartorius or Thermo Fisher.
What sterility assurance level do the 3D bags achieve, and what is the irradiation standard?
All SeamlessBio 3D bioprocessing bags are gamma irradiated at 25–50 kGy to a Sterility Assurance Level (SAL) of 10⁻⁶, in accordance with ISO 11137. This is the accepted terminal sterilization standard for single-use components in GMP pharmaceutical manufacturing. Bags are produced in ISO Class 7 cleanroom conditions prior to irradiation to ensure a low baseline bioburden. Batch-specific irradiation certificates are available on request as part of the documentation package.
Can the 3D bags be used for cryogenic storage or freezing applications?
The film material (multi-layer PE/EVOH, fluid contact ULDPE) is rated from −80 °C to +60 °C, making it compatible with cryogenic storage in principle. However, large-scale freezing in 3D cube bags — particularly at 200 L and above — requires careful consideration of freezing rate, tote hardware, and thaw protocol to avoid mechanical stress on the bag and film. For cryogenic applications, contact our technical team with your target volume, freezing rate, and hardware configuration for a specific recommendation.
Are custom manifold configurations available beyond the standard MPX connector setup?
Yes — while the standard configuration features MPX (Body/Stem) main connectors with Luer Lock or Needleless Site sampling ports, fully customised manifold designs are available on request. This includes additional sterile connectors (e.g. AseptiQuik®, Kleenpak Nova), alternative tubing materials and lengths (weldable TPE or platinum-cured silicone), additional sampling or vent ports, and multi-port assemblies tailored to your upstream or downstream process layout. Contact our team with your process requirements and we will provide a configuration recommendation and lead time.
What documentation is provided for GMP compliance and regulatory submissions?
Every batch ships with a batch-specific Certificate of Analysis (CoA), Certificate of Origin (CoO), and a Leachables, Extractables & Toxicological (Tox) Validation Guide. The manufacturing facility operates under ISO 9001 quality management. On request: irradiation certificate (ISO 11137), USP Class VI compliance statement, ADCF declaration, ISO 10993 biocompatibility documentation, and customer-specific qualification support packages for IND, CTA, and MAA submissions. There is no fixed minimum order quantity — contact our team with your volume and timeline.
Request a Quote or Custom Configuration
48h response · EU & Swiss Supply · Custom manifold configurations · Full GMP documentation
English 
Deutsch