CLAYENS Healthcare strengthens its expertise in particle cleanliness with a dedicated laboratory
In response to evolving regulatory requirements and customer specifications, CLAYENS Healthcare has set up a particulate analysis laboratory on parts at its Izernore site (France). This facility enables direct control of particulate contamination on medical devices, in addition to cleanroom production environment control.
Initial requests from industry players focused mainly on compliance with air cleanliness standards (ISO 14644 – ISO7, ISO8, etc.). New specifications now include requirements on particle levels on product surfaces, notably based on the IEST-STD-CC1246E standard.
To meet these requirements, the Izernore laboratory relies on several technologies, covering all needs from development through to serial production. This investment in diverse equipment offers analytical flexibility and precision that not all players in the sector can provide:
- Membrane extraction and automated microscopy: particles are extracted from parts by rinsing with a water + solvent mix under a microbiological safety cabinet (MSC). The liquid is then filtered onto a membrane (with pore size below 1 µm). This membrane is analyzed by an automated microscope that counts and characterizes particles by morphology: fibers, metals, inert particles. This method is mainly used in development and process validation phases.
- Liquid-phase extraction and laser detection: parts are rinsed in a water + solvent mix (also under MSC), then the liquid is analyzed directly by a liquid-phase particle counter with laser detection. This technology detects and classifies particles between 5 µm and 250 µm. It is particularly suited to routine monitoring during production, enabling fast, reproducible, and lower-cost control.
Initial findings show that a clean environment alone does not guarantee particulate control on parts. Particulate levels on parts are strongly influenced by process steps: injection, assembly, packaging, and transport. Specific control must therefore be applied at each stage of the manufacturing flow.
CLAYENS Healthcare has developed a systematic approach to analyze customer particulate cleanliness requirements, define acceptable levels, and ensure targeted monitoring of product contamination throughout development and production.
"Thanks to this laboratory, we control particulate cleanliness as soon as parts leave production", says Lucie Vion-Loisel, Head of the Healthcare Laboratory at CLAYENS Healthcare. "This strengthens the quality and compliance of our devices while giving project and production teams greater responsiveness."
This initiative fits within CLAYENS Healthcare's broader quality risk management approach and provides a concrete response to new expectations in the medical device market.
To learn more about our analysis capabilities and discuss your specific requirements, our teams are available to help.
À propos de Clayens :
CLAYENS HEALTHCARE, the Healthcare division of the CLAYENS Group, supports industrial health players (medical devices, pharmaceuticals, and diagnostics) in developing, industrializing, and manufacturing custom medical devices and plastic components in compliance with international regulatory standards.
CLAYENS Healthcare offers a full 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 United States (ISO8), and Mexico (ISO7).
Pour en savoir plus : https://www.clayens.com/healthcare.
------
Contacter-nous
+1 (347) 526-3019