Facility Relocation - Cleanrooms, Utilities, Equipment and HMI
Full commissioning and qualification for BioProtect's move to a new manufacturing facility in Netanya - cleanrooms, critical utilities, production equipment and the cleanroom HMI/PLC system.
Cleanroom IQ/OQ/PQHMI/PLC CSVUtilitiesEquipmentISO 13485
The Brief
BioProtect moved its production to a new facility in Netanya. The move needed a fast, complete C&Q campaign across cleanrooms, utilities, control systems and production equipment, with no regulatory gaps.
What We Did
- Cleanroom qualification: IQ/OQ/PQ to ISO 14644 - differential pressure, air change rates, HEPA filter integrity and airflow velocity.
- HMI and controls (CSV): validated the cleanroom HMI touchscreens and PLCs - alarm logic, user access, sensor communication, data integrity and 21 CFR Part 11.
- Critical utilities: full validation of the air handling units, compressed air and clean process loops.
- Production and packaging equipment: IQ/OQ/PQ protocols and Validation Summary Reports.
Result
A qualified, GMP and ISO 13485 compliant medical device facility with validated environmental monitoring and control.
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