A cleanroom functions as a meticulously controlled environment, crucially designed in sectors like pharmaceuticals, biotech, and electronics to maintain stringent control over air quality, temperature, humidity, and cleanliness, preventing any potential contamination. Picture a space where even the tiniest particle is a significant concern. This enclosed area is tightly sealed, ensuring continuous air filtration to eliminate particles. Individuals working within wear specialized suits to minimize the release of skin cells or particles. The primary aim is to establish an ultra-clean environment adhering to strict standards, guaranteeing the integrity and purity of manufactured products, whether it’s medicine, computer components, or sensitive scientific experiments.

At Euromedix, we boast a sophisticated cleanroom facility dedicated to the manufacturing and packaging of diverse medical devices. Our cleanroom complies with ISO 14644-1, WHO, US FDA & EU GMP standards and has the following features:

• Constructed and validated in accordance with ISO 14644-1, WHO, US FDA & EU GMP standards, the manufacturing and primary packing area aligns with ISO 8 (Class 100K) specifications, ensuring minimal airborne particle presence (not exceeding 100,000 particles of 0.5 microns per cubic foot of air).
• Utilizes non-particle shedding modular panels (Powdercoated GI with PUF infill) to ensure hermetic construction, rapid and flexible assembly, as well as smoother surfaces and edges.
• Air Handling Units (AHU) incorporate three-tier filtration systems—10 & 3-micron filters in the AHU and terminal HEPA filters in the rooms—with HEPA filters achieving 99.997% efficiency in filtering particles of 0.3 microns.
• Supplies clean air with controlled Temperature and Relative Humidity (RH) through the AHU.
• Employs epoxy flooring and coving to guarantee smooth surfaces.
• Implements unidirectional airflow across workstations and equipment to minimize contamination.
• Maintains a differential pressure of 10 Pascals between the cleanroom and adjacent areas to prevent cross-contamination.
• Provides pre-sterilized cleanroom clothing (by autoclaving) to all personnel entering the facility, minimizing contamination risks.
• Facilitates the movement of raw materials and finished goods in and out of the cleanroom through Dynamic Passboxes.
• Incorporates a Door Interlocking System in critical areas to prevent cross-contamination and unauthorized access.