Embolic Protection Devices - Cleanrooms, Utilities and HMI
Commissioning, qualification and computerized system validation of Keystone Heart's cleanrooms, utilities, assembly machinery and cleanroom HMI panels.
Cleanroom C&QHMI/PLC validationUtilitiesMachinery21 CFR Part 11
The Brief
Keystone Heart, a Venus Medtech company, makes transcatheter cerebral embolic protection systems. Commercial production required end-to-end C&Q and computerized system validation across the cleanrooms, utilities and assembly equipment.
What We Did
- Cleanroom qualification: IQ/OQ/PQ to ISO 14644 - air cleanliness, HEPA integrity, pressure cascade and air change rates.
- HMI and automation: validation of the cleanroom HMI screens and control panels - alarm handling, trend recording, access levels, data integrity and 21 CFR Part 11.
- Utilities and machinery: qualification of the HVAC units, dry compressed air and production and packaging machinery, with Validation Summary Reports.
Result
A controlled, validated manufacturing environment supporting ISO 13485 compliance for cardiovascular devices.
Planning a Facility, a Line or a Validation?
Tell us what you are building. An engineer will get back to you.