Complete certification and validation Lyostat for restarting production of active pharmaceutical ingredients with chamber leak detection and capacitor with mass spectrometer
Validated lyostat system for API production restart
Brizio Basi presents a fully certified and validated Lyostat system engineered for the controlled restart of active pharmaceutical ingredient (API) manufacturing processes.
Designed in compliance with current GMP standards, the system ensures operational continuity, vacuum integrity, and contamination control. Ideal for facilities resuming API production post-maintenance or shutdown, especially in scenarios where validated environmental control and trace contaminant analysis are mandatory.
Suitable for highly regulated environments requiring robust vacuum performance and complete traceability.
Technical Features:
- Vacuum Chamber Leak Detection: for real-time verification of vacuum chamber sealing, ensuring no loss of containment or cross-contamination
- High-Performance condenser with mass spectrometer: enables continuous monitoring of residual gases and volatile organic compounds (VOCs)
- Validation-ready architecture: for IQ/OQ validation, FAT/SAT protocols, and regulatory expectations for requalification of pharmaceutical production equipment.
