Harley Xu's Contact Details

Harley Xu's Company Details

Exact Cleanroom Compliance

Huntington Beach, California, United States • 55 Employees
Construction

Primarily, Exact Cleanroom Compliance (ECC) is an Air and Water Balancing service provider for all commercial occupancy types.ECC is differentiated and stands out in our ability to leverage and share unmatched knowledge and expertise to Biotech, Pharmaceutical and Medical Device clients. A multi-year GMP Facility Management background has given me immense insight, understanding and skills. As a Director of GMP Facilities, I had direct oversight to Facilities Maintenance, Equipment Validation and Equipment Calibration for a facility that had numerous Air Handlers, Exhaust Fans, many Clean Rooms, a Siemens BMS, a 50 HP boiler, a USP water system, a WFI Generator and Still, autoclaves, a glass washer/sterilizer, TOC Analyzers, CCA, Vacuum, HPLCs, Scales, and much more. I am deeply versed in cGMP procedures and processes including: CAPA, Deviations, Excursions, Change Control, Root Cause Analysis, Equipment Validation, Calibration, development and update of procedures, and have numerous hours of direct audit experience with the FDA, FDB and foreign regulatory agencies.This experience allows us to not only deliver high-level balancing needs, but also offer our clients additional services such as: HVAC system design review and troubleshooting, fine tuning of BMS systems (controls and alarming), and assistance with CAPA, Deviation, Change Control, procedural development and more.