Product overviewAmi Polymer Pvt. Ltd. ImaLINK™ manifold is a single-use molded tubing manifold engineered to minimize fittings and leak points. It is produced as molded straight tubing sections or with integrated connectors (T, Y, X, Tri‑Clamp) to provide seamless transitions and an unrestricted, leak‑proof flow.
Standard sizes available- Available in a wide range of internal dimensions and connector configurations to meet process requirements. Manufacturing is performed in an ISO Class 7 cleanroom with controlled material-to-finished-goods traceability.
Application- Buffer and media transfer (feeds, addition of acid/base, antifoam, growth media)
- Sample collection with minimized contamination risk
- Media filtration and inoculation
- Removal and transfer of liquids in bioprocess workflows
- Integration with carboy assemblies and peristaltic pump tubing
Compliance and Certification- FDA 21 CFR 177.2600
- USP Class VI
- USP 87 (particulate testing) and related USP standards
- ISO 10993 biocompatibility assessments
- USP 381 elastomeric closure for injection
- EP 3.1.9
- BPOG standardized extractables testing available
Characteristics- Wide range of internal diameters to match process flow requirements
- Manufactured and assembled in ISO Class 7 cleanroom environments
- Customizable tube manifolds designed to exact process and layout specifications
- Tubing materials formulated free from BPA, latex, phthalates and ADI
- Constructed from USP Class VI approved materials and compliant with FDA 21 CFR 177
- BPOG standardized extractables testing available on request
- Options include overmolded or molded connectors, filters, clamps and various tubing types
Key Features- Custom tube manifold design and internal dimensions tailored to process needs
- Seamless molded connectors (T, Y, X, Tri‑Clamp) eliminate barbed fittings and reduce leak points and entrapment areas
- Materials and production comply with pharmacopeia and regulatory standards
- Assembled and packaged in controlled cleanroom conditions
- Ready options for integration with peristaltic pump tubing and carboy assemblies
Technical specifications- Manufacturing environment: ISO Class 7 cleanroom
- Material compliance: FDA 21 CFR 177.2600; USP Class VI; USP 87; ISO 10993; USP 381; EP 3.1.9
- Extractables: BPOG standardized extractables testing available
- Design: Molded straight tubing sections and molded connectors (T, Y, X, Tri‑Clamp) for seamless, leak‑proof flow
- Options: Overmolded connectors, barbed connectors, filters, clamps, various tubing formulations; peristaltic pump tube assemblies; carboy assemblies
- Materials: Engineered tubing free from BPA, latex, phthalates and ADI
- Primary applications: Buffer/media transfer, sample collection, media filtration, inoculation, liquid removal in bioprocesses