Key infrastructure and technical specifications
FEATURE
DETAIL
WHY IT MATTERS
Enables a range of compounding activities under strict environmental control, ensuring GMP compliance for even the most sensitive products.
Cleanroom classification
Class B, C, D (with active airlocks)
Three preparation rooms (D, C, B), dispensing room, storage (NC)
Segregates activities to prevent contamination and maintain workflow efficiency.
Key rooms
+10 Pa differential between preparation areas and gowning rooms
Maintains cleanroom integrity and protects product quality by preventing cross-contamination.
Pressure gradients
Provides high-level containment for critical steps, ensuring both operator safety and product sterility.
Biosafety
Three Class A biosafety cabinets
Environmental controls
Particle monitoring, humidity, temperature, overpressure
Constant electronic monitoring with real-time oversight, reducing the risk of deviations and guarantees full GMP compliance.
Supports a wide range of IMPs, manufactured products, CMC materials, active pharmaceutical ingredients (API) and excipients.
Storage conditions 15–25°C, 2–8°C, -20°C, -80°C
Air-controlled pass-throughs, double-door fridge, large monitoring window
Enables efficient, contamination-free transfer of materials and visual QA/QP checks without breaching clean areas.
Key infrastructure
GMP 1289 IMP (2022), import and distribution rights, controlled substances (NL426), anesthetics and psychotropic compounds (N°110049)
Confirms regulatory approval for manufacturing, importing and distributing IMPs within the EU – ready to operate.
Licenses
Location advantage
Minimizes logistical delays, making same-day production and dosing possible – critical for products with minimal stability data.
<100m from trial beds – true bedside production
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