4,000 m² Cleanroom Manufacturing Plant, Hangzhou
Senior engineering expert and lead technical authority, on behalf of Keystone Heart, for Venus Medtech's 4,000 m² cleanroom manufacturing plant in China, delivered during the COVID-19 pandemic.
The Brief
A 4,000 m² cleanroom manufacturing plant in Hangzhou, China, for Venus Medtech, a structural heart therapy company. The plant was designed and built by a local Chinese design and engineering firm, at a time when the COVID-19 pandemic made travel to site almost impossible, and had to meet FDA, CE-MDR and NMPA expectations.
Our Role
Protechtiv, representing Keystone Heart, served as the senior subject matter expert, owner’s engineering consultant and lead technical authority for the project.
What We Did
- Cleanroom design review: design guidelines, layout evaluations and reviews for the 4,000 m² of cleanroom suites, including personnel and material flow segregation and pressure cascade logic.
- Critical utilities: reviewed and approved the specifications for the cleanroom HVAC, purified water generation and distribution, and oil-free compressed air.
- Sign-off: formal review and approval of drawings, equipment datasheets and tender packages - every architectural, HVAC and process infrastructure submittal.
- Remote supervision: periodic remote construction supervision and live video inspections at the critical installation milestones, holding the work to ISO 14644 and cGMP.
- Validation governance: technical review and approval of the qualification documents, from the Validation Master Plan and URS through DQ, IQ, OQ and PQ.
Result
A 4,000 m² cleanroom plant delivered to international standards, with every major design, installation and validation step reviewed and signed off by our team.
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