2D Single-Use Bioprocessing Bag | 0.5–50 L | GMP-Compatible

Product Overview

Comprehensive Overview of the 2D Single-Use Bioprocessing Bag

SeamlessBio provides high-performance 2D bags designed to be fully compatible with existing market standards. Whether you are looking for an alternative to the Sartorius Flexboy® series or Thermo Fisher ASI™ systems, our bags offer a seamless ‘drop-in’ replacement for your current bioprocessing workflow.

The High-Performance Alternative for Fluid Management

SeamlessBio 2D Single-Use Bags are engineered for the sterile handling of media, buffers, and intermediate products. Our systems are designed as a high-quality, 1:1 compatible alternative to established industry standards such as Sartorius Flexboy®, Thermo Fisher ASI™, and Merck Mobius®. This allows you to optimize your supply chain and reduce costs without the need for extensive process re-validation, ensuring a seamless “drop-in” integration into your existing workflows.

Unmatched Film Flexibility

While we leverage the industry-standard Renolit® 9101 film for its exceptional gas barrier and low extractable profile, our production is not limited to a single material. Depending on your specific application requirements, we offer a variety of multi-layer films (PE, EVOH, EVA structures), comparable to:

• Sartorius S71 equivalent film structures

• Thermo Fisher Aegis 16-44 equivalent film structures

• Custom Film Solutions for specialized chemical resistance or cryopreservation

Fully Customizable Configurations

We prioritize your process requirements over rigid standards. Every 2D system can be precisely tailored to your manifold design:

• Volume Range: 500 mL, 1 L, 5 L, 10 L, 20 L, 50 L.

• Connectors: Luer Lock (Male/Female), MPC, Septums, or sterile connectors from leading global brands.

• Tubing Options: C-Flex® (weldable), Platinum-cured Silicone, or TPE in custom lengths.

• Manifold Layout: From standard 3-port setups to complex, customized tubing assemblies.

Quality & Regulatory Compliance

• GMP Manufacturing: Produced under strict ISO Class 7 cleanroom conditions.

• Material Safety: 100% Animal-Derived Component Free (ADCF) and USP Class VI compliant.

• Traceability: Delivered with batch-specific Certificate of Analysis (CoA), CoO, and comprehensive Validation Guides (Leachables/Extractables/Tox).

• Supply Chain Security: Managed and stocked in Germany for rapid EU-wide delivery.

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Technische Spezifikationen

Feature	Specification	Industry Compatibility
Film Material	Renolit 9101 (PE/EVOH) or Custom	Replacement for S71, Aegis, Mobius
Connectors	Luer, MPC, Sterile Connectors	1:1 Form-Fit-Function
Tubing Type	C-Flex®, Silicone, TPE	Weldable & Sealable
Sterility	Gamma Irradiated (SAL 10⁻⁶)	ISO 11137
Origin	Managed in Germany	Global Supply Chain

Disclaimer

Disclaimer: Flexboy® and Flexel® are registered trademarks of Sartorius Stedim Biotech. ASI™ and Aegis™ are trademarks of Thermo Fisher Scientific. Mobius® is a trademark of Merck KGaA. SeamlessBio is an independent provider of compatible single-use solutions and is not affiliated with, or endorsed by, these companies.

Innovative Design and Flexible Volume Options

The 2D single-use bioprocessing bag is expertly designed to deliver high performance and operational flexibility across a wide volume range from 0.5 to 50 liters. This adaptability allows seamless integration into diverse bioprocess setups, whether for small-scale development or larger-scale production. Its two-dimensional flat design optimizes space utilization in bioreactors, reducing handling complexity while maintaining ease of installation and removal. As a single-use product, it minimizes cross-contamination risks and eliminates the need for cleaning, streamlining your bioprocess workflow effectively.

GMP Compatibility Ensures Quality and Compliance

This 2D single-use bioprocessing bag is fully GMP-compatible, meeting stringent industry standards essential for pharmaceutical and biotechnological manufacturing. The bag’s materials are carefully selected and validated to guarantee biocompatibility, sterility, and regulatory compliance. This makes it ideal for processes requiring reliable and traceable components, ensuring product safety and consistent batch-to-batch quality. Using this GMP-compliant bag reduces operational risks and facilitates smoother audits and validations in regulated environments.

Applications and Benefits in Bioprocessing

Designed for a variety of bioprocess applications, the 2D single-use bioprocessing bag supports cell culture, fermentation, and media storage among other uses. Its sterile, single-use nature significantly cuts down processing times by eliminating the cleaning and sterilization cycles typical with traditional reusable bags. Moreover, the bag’s robust construction provides mechanical strength and chemical resistance needed for demanding bioprocess conditions. Utilizing this product improves scalability, reduces operational costs, and enhances overall process efficiency in modern biomanufacturing facilities.

Available Formats

Format	Size
Size	150ml
	500mL
	1L
	5L
	10L
	20L
	50L

Key Benefits

Frequently Asked Questions