The production of medical gaskets takes place in a dedicated area of over 1,500 m²—the Cleanroom—certified ISO 8 and ISO 7 according to ISO 14644-1 standards.

It is a fully controlled environment, where the air is continuously filtered to remove dust particles, airborne microorganisms, aerosols, chemical vapors, and other impurities that could compromise the quality of the production process.

The Cleanroom can be considered a company within the company. It is divided into several functional areas: one dedicated to component production and finishing, one for post-curing and washing and drying operations, and finally, a zone reserved for packaging.

In addition to the production of medical gaskets, the Cleanroom is also used for special processing of industrial gaskets intended for sectors that require high cleanliness standards, such as automotive, electronics, and food & beverage, in compliance with the specific regulations of each industry.

From 2024, new production lines in ISO 8 Cleanroom

Guarnimed has installed a state-of-the-art extrusion line within its ISO 8 certified Cleanroom for the production of medical-grade transparent silicone tubing.

Thanks to this innovation, we further expand our product range by offering:

  • Platinum-cured silicone tubes
  • Strict dimensional tolerances on diameters and cross-sections
  • Custom sizes, starting from an internal diameter of just 1.0 mm
  • Customized formats in coils or pre-cut tubes with precise tolerances

In addition, Guarnimed has integrated a press for thermoplastic elastomer (TPE) molding within its ISO 8 Cleanroom.

This new production line allows us to offer high-quality, precision components for a variety of sectors, including medical, pharmaceutical, food, healthcare, and electronics.