Cleanroom Turnkey Project
Turnkey solutions for high-performance cleanrooms, with a single partner for design, execution, and validation.
Turnkey Solutions for Cleanrooms and Controlled Contamination Environments
In the pharmaceutical, nutraceutical, medical device, and biotechnology sectors, project complexity increasingly demands a single point of contact capable of managing every phase—from consulting to validation. The synergy between Nicomac's experience, the expertise of Acotec Mangini Turnkey Division, and the industrial assets of Mangini Group allows us to deliver top-quality turnkey cleanroom projects through an integrated approach that ensures maximum efficiency, reduced timelines, and full compliance with international regulations. With a global presence and cutting-edge technologies, we design and build turnkey cleanrooms optimized for performance, safety, and scalability.
Design & Build
A team of 70 project designers, operating across the Group’s various locations, manages every phase of turnkey projects, ensuring a single point of contact and one industrial partner. Whether optimizing an existing project or designing an entire infrastructure from scratch, we develop tailor-made solutions based on specific production requirements.
We directly oversee all phases, from procurement and installation to start-up, commissioning, and testing, including AIFA-certified systems. The entire project process is managed under an ISO 9001:2015 certified quality system, with compliance checks aligned with industry regulations and guidelines. Thanks to the synergy between Acotec, Nicomac, and Mangini Group, we ensure cleanrooms that meet the highest seismic safety standards, in accordance with the international protocol AC156 and NTC2018 strict Italian technical regulations and FM Approval certification.
Our Strengths
Analysis of production processes and products
Definition of the layout with careful consideration of operator, material, and final product flows
Classification of contamination levels in compliance with international standards
Verification of compliance with applicable standards and guidelines
Investment Cost Evaluation
Evaluation of design and construction timelines
Final and detailed design of the structure, systems, and monitoring equipment
Supply and installation of civil works and systems
After-sales service and maintenance
The design and construction of controlled contamination environments requires an integrated management of all aspects that ensure optimal functioning. From the construction phase to the setup, and up to the definition of preventive and corrective maintenance plans, every element is designed to ensure reliable performance, operational efficiency, and long-term durability of the systems.
Startup of the systems
Project parameters verification
Testing and commissioning in controlled contamination environments
Facility validation and equipment certification
IQ/CQ/PQ protocols execution
Training personnel on the use and maintenance of the installed system
Extraordinary maintenance
Scheduled maintenance
Recommissioning
Supervision activities and remote control
SECTORS
Our turnkey cleanroom projects are designed to meet the highest quality standards in the following sectors:
Pharmaceutical and Nutraceutical
Cleanrooms designed according to GMP and FDA regulations, with modular solutions for laboratories, production rooms, and sterile areas.
Medical Devices and Biotechnology
Controlled contamination environments certified for the production of medical devices and biotech laboratories, including BSL2, BSL3, and BSL4.
Laboratories and Biological Containment
We design, produce and install laboratories with advanced monitoring systems and isolators for applications in microbiology, chemistry, and quality control.
Nicomac Mangini Turnkey Cleanroom Project
Single point of contact for the entire process, from design to validation
Modular and certified technologies, with seismic and fire protection solutions
Over 30 years of international experience in engineering for critical environments
Compliance with the most stringent regulations for cleanrooms and sterile environments
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