SmartUnit
Smart Production Unit, Fixed or Mobile
SmartUnit is a turnkey aseptic production platform that combines isolators, environmental monitoring, and process digitalization. It is designed for rapid installation, available in fixed or mobile versions.
- Quick installation, on site or in container
- Integrated, validated, ready-to-use infrastructure
- Compatible with your equipment, ERP and quality systems
Standard Features
A compact, configurable, and ready-to-produce unit
SmartUnit integrates all the components necessary for efficient and compliant GMP production. Each unit is custom-designed to meet your technical, spatial, and regulatory requirements.
Custom modular design
Shape, size, workflow and equipment customized to your process.
Integrated SmartReg eBR
Voice-activated electronic batch record for real-time entry and traceability.
Integrated SmartEMS
Continuous environmental monitoring, with automated alerts and reports.
Integrated SmartMES
Complete MES system to control, monitor and record every step of the manufacturing process in real time.
Typical Applications
SmartUnit is designed to adapt to your specific uses
Mobile or temporary deployment
Modular container installed on site or in an isolated area, without modifying the existing building.
Manufacturing of ATMP products
Ultra-controlled sterile environments for cell culture and manipulation, including in off-site production.
Clinical-stage biotechs
Scalable solution to support the first phases of manufacturing under GMP.
Hospital pharmacies
Aseptic preparation of medications on demand, with integrated quality monitoring.
Key Benefits
The ideal solution for producing quickly, well, and in complete compliance
SmartUnit helps reduce the time and cost of installing a complete GMP line, while increasing the robustness and traceability of your processes.
- Quick installation: in a few weeks, on a fixed site or in a mobile container
- 100 % solution customized according to your products, volumes and constraints
- Reduced project costs up to 30 %
- One supplier, one validation point
- Time saving for project, quality and production teams
Why Choose SalamanderU Solutions
Technologies designed to meet the challenges of Pharma 4.0
Our solutions aren't just innovative; they're designed to adapt to your constraints, enhance your performance, and ensure regulatory compliance. Thanks to our tailored approach and multidisciplinary expertise, we support you every step of the way through your digital transformation.
Compliance & Reliability
- 100 % complies with GMP standards (GMP, Eudralex Vol. 4, FDA 21 CFR Part 11)
- Automatic recordings, complete audit trails
- Enhanced security and real-time traceability
Performance & Profitability
- Up to 30 % reduction in operational costs
- Optimization of production flows and quality control
- Acceleration of quality reviews and market launches
Flexibility & Support
- Customized solutions to your processes and constraints
- Centralized control, even for your remote or outsourced sites
- Project support from design to validation
Are you interested in our solutions?
Let's discuss your operational challenges together. Whether it's to optimize your processes, strengthen your compliance, or digitize your operations, we're here to support you.