Structural Heart Manufacturing - Cleanrooms, Utilities, Equipment and HMI
Validation of Cardiovalve's cleanrooms, HVAC and utilities, assembly and packaging machinery and cleanroom HMI panels for transcatheter heart valve production.
Cleanroom IQ/OQ/PQHMI validationUtilitiesEquipment URS to PQISO 13485
The Brief
Cardiovalve, a Venus Medtech company, develops transcatheter structural heart systems. Scaling up its manufacturing called for qualification and computerized system validation across the cleanrooms, automated equipment and environmental control systems.
What We Did
- Cleanroom qualification: IQ/OQ/PQ of the ISO cleanrooms - particle counts, recovery time, pressure cascade and HVAC airflow.
- HMI and automation: validation of the cleanroom HMI panels and environmental controls - alarms, pressure, temperature and humidity monitoring, user levels, interlocks and audit trail.
- Critical utilities: qualification of the HVAC units, dry compressed air and process utilities.
- Production and test equipment: URS, IQ, OQ and PQ for assembly, sealing and packaging machinery, with Validation Summary Reports.
Result
Validated environmental control and computerized interfaces supporting ISO 13485 compliance for structural heart implants.
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