Custom Single-Use Assemblies
Tailored Solutions for Your Complex Applications
At SaniSure, we design and craft custom single-use assemblies to meet the unique requirements of your bioprocessing applications. Utilizing our extensive and ever-expanding library of engineered components, we embrace an open architecture approach to deliver flexible, purpose-built solutions. Available in a range of materials—polypropylene, PVDF, polyethylene, polysulfone, fluoropolymers, polycarbonate, and more—our assemblies are designed to suit your specific application needs. By seamlessly integrating bags, filters, and other components, SaniSure ensures an optimized flow path and a solution truly fit for purpose.
Contact us today to design your custom single-use assembly.
Custom Solutions for Bio-Manufacturing
Your complex flow paths and critical applications deserve optimized solutions. We leverage our comprehensive library of engineered components to design and manufacture assemblies tailored to your specifications. Our expertise in advanced materials—including polypropylene, PVDF, polyethylene, polysulfone, fluoropolymers, and polycarbonate—ensures optimal performance for your unique requirements. Following a six-phase process we’re able to develop solutions specific to your unique needs.
Our Six-Phase Process
Our Products
Bottle Assemblies
Featuring PharmaTainer™ bottles and carboys, meticulously crafted from virgin ADCF resins in an ISO Class 5 environment
Bag Solutions
Discover the versatility of Flex4Sure™ bioprocess bags and assemblies, available in standard 2D, 3D, and custom configurations tailored to your unique needs.
Mixing Assemblies
Closed and open systems for powder and liquid mixing applications. Options include our exclusive Mixed4Sure™ Bottom Mounted or Top Mounted systems and PVDF-coated stir bars.
Final Filling Assemblies
Featuring Fill4Sure™ filling needles, our filling assemblies are precisely engineered to fit most common filling machines.
Transfer Assemblies
From basic to intricate custom assemblies, find the perfect fit for transferring crucial bioprocess fluids seamlessly and reliably.
Centrifuge Tube Sets
Tailored conical-bottle assemblies, including SaniSure’s exclusive Cap2V8® bottle tops, designed to meet your unique specifications.
Filter Assemblies
Upstream and downstream filtration assemblies made to your unique specifications and including a wide range of available filters.
Flask Assemblies
From basic to intricate custom assemblies, find the perfect fit for transferring crucial bioprocess fluids seamlessly and reliably.
Manifold Assemblies
SaniSure is an industry leader in manufacturing custom non-metallic fabricated fluidic manifolds for biomanufacturing.
Sampling Kits
Ready-to-use tubing and connector kits for sampling WFI and other critical media, featuring aSURE™ fused gasket technology.
Integrated Solutions
Innovative solutions spanning upstream, downstream, final fill/finish processes, and nearly every critical step in bio-manufacturing workflow.
Overview
Single-Use Assemblies
Applications
- Upstream
- Downstream
- Final Fill/ Finish
- Sterile Liquid Transfer
- Aseptic Sampling
- Freezing & Thawing applications
- Mixing Operations
Benefits
- Design Drawings Provided
- Ready to use
- Economies of scale and scope
- Vendor independent component flexibility
- 5 Redundant Cleanrooms in USA & Europe
Specifications
- ISO Class 7 Cleanrooms
- ISO 11137 sterility program
- Extractables and biocompatibility studies for components
- ISO 9001:2015 Registered
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Leading with Quality
SaniSure® provides single-use solutions for the most critical pharmaceutical and bioprocess applications. Leveraging an industry-leading quality system harmonized across our state-of-the-art ISO Class 7 cleanrooms in the USA and Europe, SaniSure consistently meets the highest quality standards. Our robust quality systems and comprehensive ISO 11137 sterility program position SaniSure as the premier provider of bioprocess assemblies globally.
