Turnkey ISO 7 Cleanroom with HMI Controls
Turnkey project management and engineering for Pi-Cardia's new ISO Class 7 cleanroom, with HMI and HVAC automation and the full validation lifecycle through PQ, plus an ongoing engineering retainer.
Turnkey project managementISO 7 cleanroomHMI & HVAC automationURS to PQEngineering retainer
The Brief
Pi-Cardia develops non-implant transcatheter therapies for heart valve repair. To scale up manufacturing it needed one partner to support the existing cleanroom and facility, and to deliver a new ISO Class 7 cleanroom from an empty space to a certified hand-over, under ISO 13485 and a tight schedule.
What We Did
- Turnkey project lead: single point of accountability for project management and engineering of the new ISO 7 suite, with Y.H. Engineering as the construction contractor - sealed envelope, high-efficiency filtration and a differential pressure cascade.
- HMI and HVAC automation: integrated the HVAC automation with the cleanroom HMI software from Biopharmex - real-time environmental monitoring, user levels, alarm escalation and data integrity.
- Validation through PQ: wrote and executed the whole lifecycle, from URS, basis of design and DQ to IQ, OQ and PQ on site.
- Engineering retainer: ongoing engineering and maintenance support for the cleanroom and the facility.
Result
A certified, validated ISO 7 cleanroom, delivered by one accountable team instead of separate subcontractors, and ongoing support that keeps it in compliance.
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