50 mL to 500 mL
Sampling and Aliquoting
Sterile, ready-to-use assemblies or manifolds adapted for sampling. Besides the standard range, SaniSure offers the ability to provide a mix of PharmaTainers™, bags, or other sampling containers.
Single-Use Bag Assemblies · SaniSure
Flex4Sure™ 2D PE Bag Assemblies
Trusted Materials. Validated Performance. Adaptable Design for Your Process.
50 mL to 20 L multilayer polyethylene bag assemblies for media, buffer, and drug substance storage and shipping in bioprocessing. Manufactured in ISO 7 cleanrooms with dual US and UK supply, Flex4Sure offers standard, configurable, and custom assemblies with options for tubing, connectors, and even the bag chambers. Validation guides are provided for both the range and each actual assembly, facilitating the use of Flex4Sure bags in your processes.
- Known PE film, extensively characterized
- Open architecture: customizable bag chambers, tubing, and connectors
- General validation guide and validation guide per actual assembly
Flex4Sure 2D PE Bag Assemblies
Overview
Flex4Sure 2D PE bag assemblies are single-use, sterile storage and shipping assemblies designed to support bioprocessing applications from laboratory and clinical scales through commercial manufacturing. They are manufactured using RENOLIT INFUFLEX® IX 9101 multilayer polyethylene film, selected for its low-extractables profile, mechanical robustness, and wide range of chemical compatibility.
With Flex4Sure 2D bag assemblies, SaniSure combines a comprehensive standard product range with advanced assembly customization capabilities, including tubing, connectors, and bag chamber standard sizes and shapes. Supported by an open-architecture design and vertically integrated manufacturing of key components such as tubing and fittings, SaniSure delivers flexible solutions tailored to your needs.
Extensive qualification testing, a global Validation Guide, and an assembly-specific validation package help streamline your validation efforts, reduce implementation timelines, and facilitate adoption within ISO 7 manufacturing environments.
Key Capabilities
2D Bag Assemblies Built Around Your Process
| Key Differentiator | What It Delivers | What It Means For You |
|---|---|---|
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Fit-for-Purpose Design
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The standard Flex4Sure 2D range covers 50 mL through 20 L. | Ready-to-use standard 2D bag assemblies fitting your process needs. Download the Flex4Sure Datasheet → |
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Open Architecture
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Specify chamber size, bioprocessing-compliant tubing material and length, and port size, with 1/8″, 1/4″, 3/8″, and 1/2″ hose barb options, along with SaniSure’s wide range of fittings and connectors. | Design your assembly in collaboration with SaniSure’s single-use experts. |
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Trusted Materials
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Flex4Sure is built on the proven RENOLIT INFUFLEX IX 9101 film, trusted in biopharmaceutical manufacturing for decades, offering a robust and fully characterized fluid-contact surface, supported by comprehensive BPOG-aligned extractables data. | Decades of proven use in biopharma manufacturing means less material characterization work for your team. |
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Gamma Sterile · SAL 10⁻⁶
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Validated per ISO 11137. Proven material resistance up to 50 kGy. Shelf life 2 years post-gamma. | Ready-to-use, single-use assemblies help reduce cross-contamination risk and support efficient process turnaround. |
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Dual-Region Supply
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Assemblies manufactured in the US and the UK. | Supply security and regional assurance for enhanced service close to your locations. |
Applications
One Platform. Every Bioprocessing Need.
From 50 mL research aliquots to 20 L process-scale bag assemblies, Flex4Sure 2D covers the full range of storage, shipping, and fluid-handling applications across development, clinical, and commercial manufacturing.
1 L to 20 L
Media, Feeds, and Buffer Storage
Low-endotoxin, gamma-sterile assemblies supported by validation and qualification documentation. USP<788> sub-visible particulate compliance.
500 mL to 20 L
Drug Substance Storage
Robust, low-extractable, low-endotoxin, and ultra-clean 2D bag assemblies with comprehensive validation data and a guide per SKU.
50 mL to 20 L
Fluid Handling
Flex4Sure 2D Bag Assemblies are designed for robust handling and efficient transportation of critical bioprocess fluids. Manufactured from high-quality film materials, these assemblies provide excellent flexibility and strength during filling, storage, and shipment.
Multilayer PE · High Strength
50 mL to 2 L
CGT and mRNA Intermediates
ADCF RENOLIT INFUFLEX IX 9101 film. Free of slip agents, lubricants, BPA, phthalates, and PFAS. Suitable for RNA-sensitive and viral vector workflows.
CGT · mRNA Compatible
1 L to 20 L
WFI and Purified Water
No slip agents or lubricants. USP<788> sub-visible particulate compliance. Suitable for purified water and WFI storage where contamination risk must be minimized.
Ultra Clean · Low Particulate
Competitive Comparison
Flex4Sure Compared With a Typical 2D Bag Supplier
The polyethylene film can be either the same or very similar. The difference is the quality, the validation package and everything attached to it, and who carries responsibility for proving the assembled fluid path works.
| Key Consideration | Typical 2D Bag Supplier | Flex4Sure 2D Bag Assemblies |
|---|---|---|
| Validation Scope | A validation guide for the product range. | A validation guide for the range and a validation package for each actual assembly, covering the entire fluid path. |
| Bag Chamber | Fixed catalog geometry. The customization happens around the chamber, not to it. | Chamber sizes and shapes are specified to the customer’s process, alongside tubing, port sizes, and connectors. |
| Architecture | Proprietary connection standards that tie the assembly to one supplier’s component range. | Open architecture. SaniSure’s vertically integrated components or known third-party components. No proprietary lock-in. |
| Supply Continuity | Single manufacturing site for some suppliers. | Camarillo, CA, USA, and Stapleford, UK, provide regional proximity, supply security, and shorter lead times. |
| Film Transparency | Proprietary or third-party film, sometimes named only by trade designation. | RENOLIT INFUFLEX IX 9101, trusted in biopharmaceutical manufacturing for decades, DMF #021124. |
Solution
Flex4Sure 2D
Bag Assemblies
Trusted Materials. Validated Performance. Configured for Your Process.
50 mL to 20 L RENOLIT INFUFLEX IX 9101 multilayer PE film. Gamma sterile, SAL 10⁻⁶. Assembled in ISO 7 cleanrooms in the US and the UK. Standard and custom tubing, connectors, and bag chambers, with a validation guide for the range and for each actual assembly.
What’s Included
What Ships With Every Assembly, and What’s Available on Request
Every Flex4Sure assembly ships with core certificates. Validation data and extended documentation, including extractables and chemical compatibility information, is available on request to support qualification activities.
Available for Every Assembly
- Certificate of Conformity per batch of bag assembly
- Certificate of Irradiation per lot for sterile assemblies
- Sterility validation
- Biocompatibility, ISO 10993 full series
Available on Request
- Validation guide for the Flex4Sure 2D bag assemblies range
- Assembly-level validation guide for easy adoption
- BPOG extractable profile for film materials under high-risk protocol
- Component USP<665> extractable profiles
- Chemical compatibility guide: solvents, buffers, cleaning agents
Frequently Asked Questions
Questions We Hear from Bioprocessing Teams
Answers drawn from real qualification and supply conversations. For anything not covered here, our team is a message away.
What volumes are available in the Flex4Sure 2D standard range?
Ten standard volumes: 50 mL, 100 mL, 250 mL, 500 mL, 1 L, 2 L, 3 L, 5 L, 10 L, and 20 L. Managed to stock, or made to order in 8 to 12 weeks. Beyond the standard range, SaniSure can customize bag chamber sizes and shapes to suit your process.
What customization options are available on a Flex4Sure assembly?
Open architecture across tubing material and length, available port sizes and layout, connection options including aseptic and sanitary connectors and filters, and manifold configurations. SaniSure can also customize the bag chamber size and shape. All custom assemblies can integrate SaniSure’s fluid management component range or known third-party components, with no proprietary lock-in.
What extractables data comes with the Flex4Sure validation package?
A BPOG high-risk extractables profile for the RENOLIT INFUFLEX IX 9101 film, plus USP<665> extractable profiles for the components. Analytical methods include acidity and alkalinity, conductivity, total organic carbon, metal ions by ICP-OES, acetate and formate by ion chromatography, volatile organic compounds by headspace GC/MS, semi-volatile organic compounds by GC/MS, non-volatile organic compounds by LC/MS, and derivatization GC/MS.
Can Flex4Sure assemblies be sourced from both the US and UK without re-qualifying?
Yes. Camarillo, CA, USA, and Stapleford, UK, manufacture to the same specification and deliver the same documentation package. The same assembly SKU is qualified once and can then be sourced from either site, giving regional proximity, supply security, and shorter lead times.
Is RENOLIT INFUFLEX IX 9101 film suitable for CGT and mRNA applications?
Yes. RENOLIT INFUFLEX IX 9101 is confirmed Animal-Derived Component Free, and the assembly is free of slip agents, lubricants, BPA, phthalates, and PFAS, making it suitable for RNA-sensitive and viral vector workflows. The material has been evaluated to applicable ISO 10993 standards, with additional extractables characterization based on USP<665>, USP<1665>, and BPOG guidance.
How does Flex4Sure compare to other bags using the same RENOLIT film?
Flex4Sure differentiates through its configurable assembly design, supporting validation documentation, and regional manufacturing capabilities. A validation guide supports the product range, with assembly-specific documentation available for configured assemblies. Bag chamber configurations can be selected based on process requirements, along with tubing, ports, and connection options.
Get Started
Every Process Has Its Own Requirements
Whether you need standard bag assemblies in stock, a custom assembly built to your chamber, port, and tubing specification, or a qualification conversation with our team, we are ready. Dual-site manufacturing means your supply is never dependent on a single facility.