Material Compatibility Assessment for Solvent-Bonded Luer Hub Assembly
Solutions
Material Science
Industries
Medical Devices; Combination Products; Drug Products

Challenge

A medical device company was finalizing the design of a luer hub-to-tubing assembly for a Class II disposable device.
The hub was to be solvent bonded to a polymeric tube, but the team was torn between three candidate materials for the luer hub:

  • Polycarbonate (PC)
  • Rigid Polyvinyl Chloride (PVC)
  • Rigid Polyester

Each material offered unique mechanical and processing advantages, but the team lacked confidence in how these materials would perform in solvent bonding and under long-term clinical exposure. The risk of bond failure, stress cracking, or extractable migration made this a critical material selection decision.

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Chemva’s Solution

Chemva led a material compatibility evaluation using HansenSolubility Parameters (HSP) to scientifically assess the interaction potentialbetween each candidate hub material, the bonding solvent, and the polyurethanetubing.
Our process included:

  1. HSP Analysisof Materials and Solvents:
    • Calculatedand compared the HSP values (δD, δP, δH) of each candidate polymer against thePU tubing and typical solvent blends (e.g., cyclohexanone, tetrahydrofuran, andmethyl ethyl ketone).
    • Evaluatedthe “solubility distance” between materials to predict compatibility or risk ofswelling/degradation.
  2. Performance& Risk Mapping:
    • Polycarbonate(PC): Showed moderate compatibility with bonding solvents but a higher risk ofenvironmental stress cracking (ESC) when exposed to alcohols or disinfectantsin clinical settings.
    • Rigid PVC:Strong bonding potential but raised concerns about lower long-term dimensionalstability.
    • RigidPolyester: Demonstrated favorable HSP alignment with solvent and maintaineddimensional and chemical stability post-bonding.
  3. AdditionalScreening Considerations:
    • Assessedbiocompatibility profiles, sterilization compatibility (EtO, gamma), andregulatory precedence for each material.
    • Designedexperiments to evaluate a preliminary bond strength screening using benchtopsolvent-bonding trials and visual inspection for discoloration ormicrocracking.

Based on HSP compatibility, chemical resilience, and bonding performance,Chemva recommended polyester as the top choice, with rigid PVC(non-plasticized) as a secondary option. Polycarbonate was deprioritized due tohigher ESC risk in the intended use environment and sensitivity to solventinteractions.

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Impact Delivered

Chemva’s evidence-based approach helped the client:

  • Avoid downstream bonding failures or field returns due to material-solvent mismatch.
  • Accelerate design freeze by providing confidence in material selection.
  • Build a scientifically justified material rationale that could be used in regulatory submissions and technical files.
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