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TOP 10 CONSIDERATIONS WHEN MOLDING DIAGNOSTIC CARTRIDGES

Molding diagnostic cartridges, lateral flow components, and intricate
microfluidic devices is an art that blends the science of mold design, injection
molding, and in-vitro diagnostic (IVD) device manufacturing. This expertise
guarantees the seamless creation of top-tier, validated, and easily scalable IVD
components. Diagnostic cartridge molding involves several crucial factors that
should be integrated into your project plan.


CLICK HERE

to learn more about Freudenberg Medical’s IVD development and manufacturing
capabilities.


HERE'S A BREAKDOWN OF THESE IMPORTANT CONSIDERATIONS:



1. Careful Material Selection Opt for a medical-grade material that suits the
diagnostic purpose, such as a medical USP Class VI material or one resistant to
lipids. The material should have good dimension stability, chemical resistance,
and, if visuals are essential, transparency.

 

2. Thoughtful Mold Design Design the mold with care and consideration for
accurate and consistent replication of the diagnostic cartridge. Make sure you
specify uniform cooling and heating channels for dimensional control, carefully
select an appropriate gate type and location to minimize shear stress, and
provide ample draft angles for easy release and to avoid stress during ejection.

 

3. Strategic Tooling Decisions Tailor the mold tooling to match the required
volume and complexity of the cartridge. Factors like the number of cavities,
cooling channels, and mold material play a role in optimizing production
efficiency.

 

4. Smart Parting Line and Gate Design Determine where to position the parting
line and gate to minimize excess material, or flash, and guarantee proper mold
filling. The gate's positioning should prevent trapped air and interruptions in
the flow.

 

5. Precise Tolerances and Surface Finish Pay attention to the specific
tolerances and critical dimensions necessary for proper functionality. You
should also focus on achieving the right surface finish for the cartridge's main
contact points and flow characteristics.



6. Adequate Venting Incorporate appropriate venting mechanisms to allow air and
gasses to escape during the molding process. Inadequate venting can lead to
cosmetic defects, voids, or haziness on the surface, potentially affecting the
clarity of light transmission during diagnostic testing.

 

7. Meticulous Processing Ensure scrupulous hygiene and proper machine
maintenance during molding to achieve low fluorescence. Regularly clean the
screw and barrel, maintain low shear and resistance time, eliminate
interruptions, and degas the polymer before processing.

 

8. Seamless Assembly Compatibility If additional components are needed for
cartridge assembly, design the molded parts to simplify integration with
elements like sensors, electronics, or membranes.

 

9. Quality and Regulatory Compliance Validate the molding process for
robustness, ensuring repeatability and reproducibility for a reliable and
high-quality product. Since diagnostic cartridges are intended for medical or
regulated application, they also need to comply with all relevant standards,
such as ISO 13485 and FDA guidelines.

 

10. Efficient Cost Management Evaluate the cost-effectiveness of the molding
process based on factors such as tooling costs, material efficiency, cycle time,
and potential scalability for large-scale production.




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to delve deeper into Freudenberg Medical's comprehensive development, and
manufacturing capabilities or to discuss your IVD project. We're with you every
step of the way.

 


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Medtech Rising 2023 12/07/2023 - 12/07/2023 The Galmont Hotel, Galway
MD&M West 2024 02/06/2024 - 02/08/2024 Anaheim, California USA Booth # 2113
INTERPHEX 2024 04/16/2024 - 04/18/2024 New York
CPhI & PMEC India 11/28/2023 - 11/30/2023 India Expo Centre, Greater Noida,
Delhi NCR Booth 15.A22
Medtech Rising 2023 12/07/2023 - 12/07/2023 The Galmont Hotel, Galway
MD&M West 2024 02/06/2024 - 02/08/2024 Anaheim, California USA Booth # 2113
INTERPHEX 2024 04/16/2024 - 04/18/2024 New York
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