Cleanroom for Medical Devices
Nicomac designs, builds, and installs cleanrooms for the production and assembly of medical devices. Our range of modular solutions allows for the setup of cleanrooms compliant with ISO 8, ISO 7, and ISO 5 standards, ensuring controlled and safe environments for every stage of medical device manufacturing.
Features of Nicomac Cleanroom for Medical Devices
All stages of production, assembly, and packaging of medical devices must take place in controlled contamination environments. Nicomac’s modular cleanrooms for medical devices offer the highest level of safety and compliance with international regulations.
Thanks to advanced HVAC systems, effective air filtration, and sterilization solutions, we ensure compliance with the highest standards. The use of flush, durable materials facilitates cleaning and enhances operational efficiency.
For electromedical devices, Nicomac pays special attention to the coatings of surfaces, benches, and worktops, offering antistatic and removable wall systems to facilitate the transfer of large equipment.
High mechanical resistance of the walls, ensuring long-term durability and structural stability.
Resistance to cleaning chemicals, ensuring a consistently sterile and safe environment.
Maximum airtightness, to maintain contamination control.
No particle retention and no proliferation of contaminating agents (crucial in post-sterilization processes).
Certified materials compliant with international standards for electrical systems, walls, and ceilings.
cGMP Consulting.
ISO 14644 Cleanroom Environments for Medical Devices
ISO 14644 is the internationally recognised standard that defines the classification, design, testing, operation and ongoing monitoring of cleanrooms and controlled environments. The series comprises multiple parts, with ISO 14644-1 establishing cleanroom classification from ISO Class 1 (the most stringent) to ISO Class 9 (the least stringent), based on maximum allowable concentrations of airborne particles of specified sizes per cubic metre. This classification system provides a consistent, measurable framework for cleanroom cleanliness, essential for contamination-sensitive sectors such as medical device manufacturing.
Meeting ISO 14644 is important because it underpins product safety, ensures global regulatory compliance (including GMP requirements), and enables standardised cleanroom practices across locations and industries. It also enables facilities to demonstrate objective cleanliness control through verifiable data, reducing risks of contamination and supporting audits and quality assurance programmes.
To achieve ISO 14644 certification, cleanrooms must undergo rigorous validation, which includes the testing of airflow, filtration systems, pressure differentials, and key environmental parameters such as temperature and humidity. Particle counting plays a central role in this process: specialised counters are used to measure airborne particles as small as 0.1 µm, with results evaluated through precise sampling methods and statistical analysis to verify compliance with the required class.
Classification and monitoring activities, defined in ISO 14644-1 and ISO 14644-2, are performed both in at-rest and operational conditions, and must be repeated regularly. Re-classification and continuous monitoring with clearly defined thresholds are necessary to ensure that standards are consistently maintained.
Equally important are the principles set out in ISO 14644-4 and ISO 14644-5, which guide the design, construction, and operation of cleanrooms. These include the use of appropriate materials, effective airflow control through HEPA or ULPA filters, correct pressure differentials, and operational protocols that cover garments, equipment handling, cleaning, and personnel behaviour.
Validation methods described in ISO 14644-3 further support compliance by testing airflow velocity, filter integrity, pressure differentials, and environmental controls. Finally, the broader ISO 14644 series extends to every phase of the cleanroom lifecycle, from vocabulary and operational practices to molecular and surface contamination, ensuring that environments remain reliable and compliant from design through to decommissioning.
Turnkey solutions for cleanrooms and production facilities
Thanks to its collaboration with Acotec Mangini Turnkey Division, Nicomac offers a turnkey service for the creation of complete systems, positioning itself as the sole project reference and industrial partner. This integrated approach optimizes the entire production cycle, simplifying management and reducing installation times.
Certified Seismic Cleanrooms
Nicomac cleanrooms are synonymous with safety, even in the event of earthquakes. Nicomac Mangini is the only company worldwide to develop a patented Seismic-Proof Cleanroom system, tested according to the international AC156 protocol and fully compliant with the NTC2018 Technical Standards.
This advanced technology ensures complete protection for both people and equipment, preventing damage to the cleanroom, eliminating restoration costs, and guaranteeing operational continuity even in the event of extreme seismic activity.
Modular Building meets Modular Systems
Nicomac Mangini’s modular solutions meet the needs for efficiency, sustainability, and rapid installation in the development of new production facilities for the medical and pharmaceutical sectors.
We offer a range of options, including Prefabricated Modular, Container Modular, and MyCUBIK, all integrated with the Mangini Group’s Hybuilt system for customized modular buildings, cleanrooms, and internal partitions.
Human-Centered Cleanroom
Nicomac Mangini is revolutionizing the concept of cleanrooms by placing operator well-being at the center. Our innovative design approach focuses on enhancing safety and productivity while ensuring a more comfortable working environment.
Traditionally, cleanrooms are cold and alienating spaces, often contributing to increased stress and reduced staff motivation. Nicomac offers an ergonomic, comfort-focused design, giving companies the opportunity to stand out with a human-centered approach that values their workforce and optimizes performance.
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