Top Clean Packaging Meets the Challenges of Surgical Robotics
Top Clean Packaging Meets the Challenges of Surgical Robotics
Industrial Expertise Serving Surgical Robotics
With operations in France, China and the United States, Top Clean Packaging supports healthcare companies in the development and manufacture of medical devices and pharmaceutical products. As a CDMO (Contract Development and Manufacturing Organization), this family-owned company combines technical expertise, process know-how and industrial support, from initial design through to manufacturing.
Its surgical robotics activities have grown through several co-development and component manufacturing projects, drawing on a range of complementary capabilities: the design of positioning systems, metal insert overmolding and subassembly integration.
Bioburden Reduction and Overmolding
Combining metal and polymer in a surgical robotics component manufactured in an ISO Class 7 cleanroom requires rigorous control of cleanliness, positioning and insert retention during the injection molding process.
To meet these requirements, Top Clean Packaging has dedicated equipment that can reduce the bioburden of metal components to below 50 CFU before overmolding or assembly, depending on the initial cleanliness of the parts and the materials used. The objective is to ensure that medical devices have a bioburden of less than 100 CFU when leaving the cleanroom, prior to sterilization, while maintaining strict control over the cleanliness of the manufacturing environment.
Installed in cleanrooms, the injection molding machines can be adapted to different production volumes: manual insert loading for small batches or automated loading using six-axis robots for higher-volume production. With clamping forces ranging from 30 to 450 tonnes, the machine fleet can accommodate a wide variety of component sizes and tooling configurations. Materials processed include PEEK, PPSU and IXEF, which are suited to the mechanical, thermal and dimensional requirements of robotic applications.
Managing Tolerances and Inspecting Every Part
In surgical robotics, the accurate positioning of instruments is essential. Top Clean Packaging has co-developed several positioning systems to meet this requirement, implementing a range of solutions:
- Reducing the number of components: For one of these systems, design optimization made it possible to reduce the number of components, thereby limiting assembly interfaces and cumulative tolerances.
- 100% dimensional mapping: Top Clean Packaging has developed a dedicated process for components incorporating metal spheres, whose positioning determines the accuracy of the system during surgical procedures. The service includes injection molding, assembly of the spheres and dimensional inspection of 100% of the parts. An inspection report is printed on a card in the cleanroom and then attached to the medical device to ensure traceability throughout its entire lifecycle, from manufacturing to use by the end user. Located within the ISO Class 7 cleanroom, the metrology area makes it possible to carry out these inspections without removing the parts from the controlled environment.
Assembly, Wiring and Packaging
The acquisition of Axcesor in the United States in 2025, a specialist in custom cable manufacturing and medical device assembly, further strengthens the Group's capabilities in wiring and the production of functional subassemblies.
Packaging completes this offering. To protect instruments featuring complex geometries, fragile areas or specific retention points, Top Clean Packaging develops custom TPU protective solutions and tailored blister packaging. These solutions help minimize the risk of damage during transportation, storage and handling.
"Our design experience and the complementary nature of our manufacturing processes enable us to address several key challenges: reducing the number of components to better control tolerances, integrating inserts through overmolding, assembling and wiring components, and then designing appropriate protective packaging. It is this ability to connect all these stages that gives us a competitive edge in medical robotics," explains Philippe Chazelle, Key Account Manager and robotics applications expert.
Already involved in robotic applications in cardiology, orthopedics, dentistry and visceral surgery, Top Clean Packaging has identified medical robotics as a key development area for the next ten years.
Top Clean Packaging will be exhibiting at Compamed, Hall 8b, Booth F10-11.
