Custom FLUID MANAGEMENT

By balancing the User Requirement Specifications you provide with our fluid transfer expertise—such as flow rate, pressure, shear sensitivity, hold-up volume, and sterility requirements—we engineer a closed, optimized flow path using the most appropriate tubing, connectors, manifolds, and filtration components.

We maintain an extensive library that includes pump-grade tubing, connections, fittings, PharmaTainer™ bottles and carboys, Cap2V® closures, bioprocess bags (2D/3D/custom), manifolds, filters, conical bottles, sampling kits with aSURE™ fused gaskets, mixing systems, and filling needles.

Assemblies can be engineered using polypropylene, PVDF, polyethylene, polysulfone, fluoropolymers, and polycarbonate—selected to meet specific chemical compatibility, mechanical durability, gamma stability, and extractables/leachables requirements.

PharmaTainer™ bottles are manufactured from virgin ADCF resins in ISO Class 5 conditions, providing extremely low particulate, bioburden levels, and are nuclease free. They offer high clarity, excellent chemical compatibility, and proven stability under freezing, storage, and transport conditions.

Cap2V® closures deliver aseptic and high-integrity sealing. The tubing is molding into the cap closure which eliminates the need for hose barb and zip tie connections, ensuring sterility for high-purity biologicals and minimizing contamination risk during sampling, transfer, and storage operations.

Configurations can include media and buffer filtration tubing transfer sets, perfusion loops, gas-handling filters, harvest-transfer connections, and sampling nodes—customized for parameters like cell density, vessel working volume, tubing ID/OD, and required sterility assurance levels.

We engineer assemblies for buffer management, fraction collection, column loading, low-pH viral inactivation holds, UF/DF buffer exchange, and viral filtration (including PUPSIT assemblies)—ensuring consistent flow control, validated filter configurations, minimal hold-up volume, and compatibility with facility instrumentation.

Options include depth filters, sterilizing-grade 0.1, 0.2, or 0.45 µm membranes, prefilters, bioburden-reduction filters, and specialized media for high-viscosity fluids. Assemblies can incorporate sterile connectors, pump tubing, and pressure/temperature-monitoring devices.

PUPSIT configurations enable pre- and post-use integrity testing with bubble point or diffusion connection points, including stable pressure control, bypass loops, isolation valves, and sampling ports aligned with Annex I guidance on risk management.

Extractables testing is performed in accordance with USP . Moderate risk level testing is conducted on all validated materials, while high risk level testing is available upon request. An Extractables Data Profile can also be provided upon request.

Transfer assemblies, including container and filter assemblies, are designed for sterile fluid transfer and typically incorporate sterile-welding tubing, aseptic connectors, tubing-to-hose barb connections, and pump-rated pumping systems. These assemblies are tested using pressure decay methods to confirm the absence of leaks, ensuring product integrity and sterility throughout the process.

Flex4Sure™ bags can be supplied in 2D, 3D, or fully custom geometries with integrated ports, custom tubing lengths, fill/drain configurations, gamma-compatible films, and weldable tubing—matched to the facility’s storage, mixing, or transfer requirements.

Final filling systems are designed using Fill4Sure™ precision needles and sterile pathways tailored to filling machine interfaces, minimizing turbulence, ensuring repeatable dosing, and maintaining drug product sterility and viscosity handling capabilities.

Manifolds are fabricated using biocompatible materials with precision joining, port alignment, flow modeling, and leak testing. Configurations may include branching flow paths, integrated filters, sampling points, and sensors to streamline fluidic operations.

Through progressive design reviews, engineering drawings, prototyping via SMART, iterative testing, and verification against defined User Requirement Specifications provided by end-users, the method identifies issues early, accelerates optimization, and ensures manufacturability, sterility, and regulatory readiness.

We provide material compliance documentation, extractables/leachables data (as available), manufacturing controls, gamma-irradiation validation parameters, component CoAs, and traceability information for all fluid-contact materials.