CLAYENS Healthcare strengthens its expertise in particle cleanliness with a dedicated laboratory
In response to evolving regulatory requirements and increasingly demanding customer specifications, CLAYENS Healthcare has established a particulate analysis laboratory at its Izernore site (France). This new facility enables direct control of particulate contamination on medical devices, complementing cleanroom environment monitoring during production.
While initial industry requirements primarily focused on compliance with air cleanliness standards (ISO 14644 – ISO 7, ISO 8, etc.), recent specifications now include strict limits on the level of particles found on product surfaces, particularly in accordance with the IEST-STD-CC1246E standard.
To meet these new demands, the Izernore laboratory relies on multiple technologies, covering the full spectrum of needs—from development to mass production. This investment in diversified equipment provides analytical flexibility and precision that few players in the industry can match:
- Membrane extraction and automated microscopy: Particles are extracted from parts by rinsing them with a water + solvent mix under a microbiological safety cabinet (MSC). The liquid is filtered through a membrane with pores smaller than 1 µm. This membrane is then analyzed using an automated microscope that counts and characterizes particles by morphology—fibers, metals, and inert particles. This method is primarily used during development phases and process validation.
- Liquid-phase extraction with laser detection: Parts are rinsed using the same water + solvent mixture under MSC, and the resulting liquid is directly analyzed by a liquid-phase particle counter with laser detection. This technology identifies and classifies particles between 5 µm and 250 µm. It is particularly well-suited for routine in-line monitoring during production, offering fast, reproducible, and cost-effective control.
Initial findings show that a clean environment alone is not enough to ensure particulate control on parts. The level of contamination is heavily influenced by each step of the manufacturing process: injection, assembly, packaging, and transport. Specific control must therefore be applied to each stage of the production flow.
CLAYENS Healthcare has developed a systematic approach to analyzing customer requirements for particulate cleanliness, defining acceptable levels, and implementing targeted monitoring of contamination throughout product development and manufacturing.
"Thanks to this laboratory, we are able to control particulate cleanliness right at the end of the production line," explains Lucie Vion-Loisel, Head of the Healthcare Laboratory at CLAYENS Healthcare. "It reinforces both the quality and compliance of our devices, while offering reactivity to our project and production teams."
This initiative is part of CLAYENS Healthcare’s broader commitment to quality risk management and provides a concrete response to the evolving expectations of the medical device market.
To learn more about our analysis capabilities and to discuss your specific requirements, our teams are here to support you.
About CLAYENS:
CLAYENS Healthcare, representing the healthcare activity of the CLAYENS Group, supports industrial health players (medical devices, pharmaceuticals, and diagnostics) in the development, industrialization, and manufacturing of custom medical devices and plastic components in compliance with international regulatory standards.
CLAYENS Healthcare offers a complete service, from R&D to production, including industrialization, qualification, validation, and regulatory support.
Present in 9 countries, the CLAYENS Group has nearly 5,000 employees and 32 manufacturing sites. The Group's 8 cleanrooms are located in France (ISO7), the USA (ISO8), and Mexico (ISO7)
More information : https://www.clayens.com/healthcare.
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