Overview

• Post By : Rajkumar Aghera,Deputy Manager- Domestic Marketing Ami Polymer Private Limited


• Source: Ami Polymer Pvt Ltd


• Date: 05 Mar,2026

The pharmaceutical and biopharmaceutical industries have high and strict standards for maintaining sterility. Single-use technologies (SUTs) have changed this by helping companies reduce risk for contamination, help streamline production, and ease validation.

But traditional assemblies of tubing, connectors, and ports have numerous challenges. That includes leaks, dead volume, and mistakes during assembly. This is where the ImaLINKTM overmoulded assemblies from AMI Polymer come in. By integrating multiple components of a fluid handling system into a single assembly, they eliminate potential failure points and provide consistent operation for the most critical activities in sterile fluid transfer, fluid sampling and filter integrity test (PUPSIT) audits.

Seamless by Design

The magic is in overmoulding, which creates a permanent bond of tubing, connectors, and housings into a single, integrated interface. No adhesives. No threaded fittings. No mechanical joints. Just one seamless fluid channel.

Why it matters:

1. No dead legs → less risk of contamination
2. Consistent dimensions → reproducibility every time
3. Flexible design → tailored diameters and optional add-ons like filters or clamps
4. Stronger, cleaner, safer → fewer assembly steps, fewer risks

In short, it’s a design built for sterility, strength, and peace of mind.

Materials That Put Safety First

All components of an ImaLINKTM assembly use pharmaceutical-grade plastics that also won’t leach harmful substances to the sensitive biologics being handled.

The plastics used in ImaLINKTM assemblies include:

1. Polypropylene (PP): great strength and chemical resistance
2. Polyethylene (PE): decent flexibility and impact resistance
3. Thermoplastic Elastomers (TPE): preference for seals and strain relief
4. Silicone and elastomers: optional depending on process requirements

All assemblies are also ADI-free, phthalate-free, latex-free, and BPA-free, and can endure autoclave, gamma, or e-beam sterilization. Constructed in ISO Class 7 cleanrooms, all assemblies are sterile from the outset.

Built for Compliance

In pharma, compliance isn’t optional its survival. ImaLINK^TM assemblies are designed to tick all the right boxes:

1. USP <87> & <88> Gross & Montalvo, USP <87> <88> Cytotoxicity <88> & Biological Reactivity.
2. ISO 10993: Biocompatibility.
3. FDA 21 CFR 177/2600: polymers.
4. EP 3.1.9
5. USP <381>: Elastomeric closures for injections.
6. BPOG Standardized Extractables Testing.

On top of that, AMI Polymer runs a tight ship under ISO 13485 quality management, ensuring full traceability, change control, and sterilization validation.

Real-World Applications

Sterile Fluid Transfer From bioreactor feeds to chromatography and buffer prep, ImaLINK^TM assemblies keep fluids moving safely.

1. No leaks
2. No contamination
3. Minimal hold-up volume
4. Stable flow and pressure

Sampling Manifolds Need to test process fluids without breaking sterility? These manifolds make it easy.

1. Integrated sample ports
2. Minimal dead volume
3. Repeatable geometry
4. Less operator intervention

Perfect for QC sampling, in-process checks, and media fill validation.

PUPSIT Assemblies Filter integrity testing after use is a regulatory must under EU GMP Annex 1. ImaLINK^TM assemblies make it straightforward.

1. Dedicated pressure and vent pathways
2. Direct filter housing connections
3. Support for bubble point, diffusion, or pressure decay tests

The result? Repeatable, reliable testing with less manual hassle.

Operational Guidance

To get the best out of ImaLINK^TM assemblies:

1. Pre-use: inspect, verify, and confirm sterilization.
2. Integration: use validated connectors, support mechanically, and align properly.
3. Operation: respect pressure/temperature limits, avoid sharp bends, and keep flow laminar.
4. PUPSIT: follow SOPs carefully, ramp pressure gradually, and document everything.

Risk Mitigation at a Glance:

Conclusion

ImaLINK^TM overmoulded assemblies aren’t just another piece of equipment they’re a smarter way to handle sterile fluids. By combining clever design, trusted materials, and strict compliance, they give pharma and biopharma manufacturers confidence in every transfer, sample, and test.

About AMI Polymer

AMI Polymer is a trusted global partner for single-use and polymer-based solutions in pharma and biopharma. Their mission? Deliver components that are safe, reliable, and regulatory-ready so manufacturers can focus on innovation, not troubleshooting.

Authored by: Rajkumar Aghera

Deputy Manager- Domestic Marketing

Ami Polymer Private Limited
[email protected]