OverviewAmi Polymer ImaLINK™ single-use molded tubing manifold provides seamless fluid paths by integrating molded straight tubing sections and molded connectors (T, Y, X and Tri‑Clamp). The design eliminates barbed fittings and reduces potential leak and entrapment points for continuous, unrestricted, leak‑proof flow suitable for bioprocess applications.
Standard Size Available- Multiple ImaLINK™ manifold options offered across a wide range of internal diameters to match process flow requirements.
- Manufactured in an ISO Class 7 cleanroom with controlled production from raw materials to finished assemblies.
Application- Buffer and media transfer (feeds, addition of base/acid, antifoam, growth media and other process liquids)
- Sample collection with minimized contamination risk
- Media filtration and sterile fluid handling
- Inoculation lines
- Liquid removal from bioprocess vessels
- Carboy and reservoir assemblies
- Peristaltic pump tubing assemblies
Compliance and Certification- FDA 21 CFR 177.2600
- USP Class VI
- USP 87 (Biological Reactivity Tests)
- ISO 10993 series
- USP 381 elastomeric closure for injection
- EP 3.1.9
- BPOG standardized extractables testing available
Characteristics- Seamless molded tubing sections and molded connectors to eliminate barbed fittings and reduce entrapment zones
- Offered in a broad range of internal dimensions for process-specific flow control
- Manufactured and assembled in ISO Class 7 cleanroom environment with controlled documentation
Key Features- Customizable tube manifolds to meet precise process and design requirements
- Tubing materials free from BPA, latex, phthalates and ADI
- Materials selected to meet FDA 21 CFR 177 standards and USP Class VI requirements
- BPOG standardized extractables testing supported
- Assembled and packaged in ISO Class 7 cleanroom
- Optional components: overmolded connectors, barbed connectors, inline filters, clamps and various tubing options
Technical specifications- Product name / series: ImaLINK™ (Ami Polymer)
- Manufacturing environment: ISO Class 7 cleanroom
- Materials: USP Class VI approved materials; tubing free from BPA, latex, phthalates and ADI
- Regulatory compliance: FDA 21 CFR 177.2600; USP Class VI; USP 87; ISO 10993; USP 381; EP 3.1.9
- Testing: BPOG standardized extractables testing available
- Design: Molded tubing sections and molded connectors (T, Y, X, Tri‑Clamp) providing seamless, leak‑proof flow without barbed fittings
- Customization: Wide range of internal dimensions and customizable manifold assemblies to meet exact process requirements
- Packaging: Assembled and packaged in ISO Class 7 cleanroom with traceable documentation