Project Feature: Neurocrine Aperture Qualification
- Teresa Schneider
- May 8
- 2 min read
Project Summary
Location: San Diego, CA
Dates of Service: 2025-2026
Services Performed: Critical GMP Utilities Qualification, Temperature Mapping, URS Development, SOP Development
Number of Buildings: 2
Systems Qualified: RO/DI water, nitrogen gas, vacuum, clean compressed air, temperature-controlled units (refrigerators and freezers), HVAC, and ultra-purified water system
Project Background
Neurocrine Biosciences, Inc. (NBI) is dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders.
NBI’s new Aperture campus contains four multi-story office and research buildings totaling over 535,000 square feet with an option to add a fifth building in the future.
GMC Commissioning provided comprehensive commissioning services throughout Design, Construction, and Occupancy phases for the entire campus. For more details, see the Neurocrine Aperture Project Feature. GMC Commissioning provided GMP Commissioning services for the critical utility systems and was asked to provide additional qualification services.
GMC Cx Support and Delivery
GMC Commissioning performed qualification and validation services for the systems and utilities serving the GMP spaces located in the Neurocrine Aperture campus. GMC Commissioning worked with NBI QA, Facilities Engineering, and SMEs to develop user requirement specifications; installation, operation, performance qualification protocols; final summary reports with trace matrices; and standard operating procedures including operation and preventive maintenance, pest control, calibration and preventive maintenance program, and water systems monitoring. Multiple temperature-controlled units (TCUs) required temperature mapping services, which GMC Commissioning performed in-house. See our Temperature Mapping blog post for more details on our approach and expertise.
Our familiarity with the systems, buildings, and construction team in conjunction with our expertise of critical GMP utilities and support systems made us the optimal team to conduct the qualification. With the construction team ramping down upon construction completion, our background on the project was absolutely crucial to the success of the qualification efforts. We successfully qualified the RO/DI and ultra-purified water systems, clean compressed air, vacuum, HVAC, nitrogen, and TCUs.
Through our positive collaboration with NBI, we were not only able to meet all of the project goals, but we have forged a strong, lasting relationship between GMC Commissioning and Neurocrine Biosciences.
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