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

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Features | Applications | Benefits | Complete solution

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