ISO Class 5
Aseptic fill cleanroom status
< 0.1 µg/m³
HPAPI containment threshold
99.8%
Commercial batch yield rate
24 Days
Standard technical transfer lead
Containment engineered around the target molecule, eliminating post-run forensic remediation.
Batch records are compiled in real time for immediate submission to European and American regulatory authorities, backed by computerized analytical tracking and closed-barrier isolation systems.
Specialized drug product manufacturing
Modular cleanroom configurations designed for agile clinical and commercial scale fill-finish campaigns.
Sterile Injectables
HPAPI Isolation
Automated Lyophilization
Vials, cartridges, and pre-filled syringes filled under continuous laminar air flow with automated weight verification and nitrogen head-space purging.
Negative-pressure glovebox isolators engineered for cytotoxic and cytostatic active compounds requiring containment down to occupational exposure band five.
Dual freeze-drying units with controlled ice nucleation directly linked to sterile vial capping modules under monitored sub-zero temperature conditions.
Submit formulation profiles and volume requirements for direct technical feasibility evaluation within forty-eight hours.