Turnkey Cleanroom Design and Construction for Medical Device Manufacturing, Slovakia

Client

Our client is a fast-growing company specializing in the manufacture of packaging for medical devices. Thanks to its innovative technological solutions and high-quality standards, the company decided to invest in new facilities in order to expand production.

Service

The client requested that we design and fully construct a turnkey cleanroom. The client already operated a cleanroom and had experience with cleanroom operation. However, to support the planned production of medical-device packaging, the client required a new space—primarily to achieve a higher specified cleanliness class.

A portion of the existing cleanroom was converted into changing rooms and a transition area leading into the new cleanroom. The new cleanroom was tailored to the client’s manufacturing process and meets ISO Class 7 standards. A primary requirement was rigorous compliance with hygiene and technical standards essential to this industry. This standard was upheld throughout the design, refurbishment of existing areas, and construction of new facilities.

The implementation schedule was met in full. Because of ongoing production on the original premises, we had to adapt to ongoing operations while avoiding restrictions on staff or material movement. At a certain stage of the project, temporary passageways were built, as employee safety was treated as a priority equal to the continuity and quality of current production. Coordinating subcontractors alongside the client’s production process was a given.

We positioned the cleanroom technology on the second floor. By constructing a dedicated service staircase, we established a robust technical backbone for the cleanroom and ensured convenient access to equipment.

Air filtration relies on advanced FFU (Filter Fan Unit) systems with HEPA filters. Cleanroom parameters and system monitoring are controlled via a PLC display accessible to trained operators. Operators with questions about settings can contact our service center. A major advantage for the client is remote access: a CARE OF AIR technician can adjust cleanroom settings remotely and diagnose the source of any parameter deviations. Production does not require interruption—communicating the situation to us is sufficient.

During the final handover, we prioritize thorough training of personnel and accountable staff. Effective cleanroom operation prolongs the service life of installed components and maintains compliance with required hygiene standards.

Conclusion

Throughout construction, we addressed every client detail. Precise filtration configuration and a robust HVAC system ensured optimal temperature, humidity, and pressure. We concluded the project with validation measurements and full documentation, using data to confirm cleanroom compliance with all parameters.

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