Commissioning for Life Sciences Facilities: Ensuring Peak Performance & Compliance
For life sciences facilities, Commissioning is not merely a checkbox exercise; it is a critical process that validates the functionality, performance, and compliance of every system and piece of equipment. At Genesis AEC, our Commissioning experts ensure that your complex facility operates exactly as intended, from day one, meeting stringent regulatory requirements and supporting your vital operations.
In environments where precision, reliability, and regulatory adherence (e.g., FDA, cGMP) are non-negotiable, diligent commissioning is essential. It minimizes the risk of costly post-occupancy issues and accelerates the path to operational readiness. Our comprehensive commissioning process includes:
Design Review: Ensuring systems are designed for testability and performance.
Factory Acceptance Testing (FAT) & Site Acceptance Testing (SAT): Verifying equipment performance before shipment and confirming proper installation.
Functional Performance Testing (FPT): Rigorously testing individual components and integrated systems under various operational scenarios.
Operational Readiness & Turnover: Preparing your teams for efficient operation and providing comprehensive documentation.
Commissioning Program Development, FMEA, Whole Building, Equipment, Building Envelope Commissioning, System Performance Assessments, ISO-14644 Clean Room Certification Support, Water and Gas System Certification Support, Preventative Maintenance Plans, SOPs, CMMS Support, Critical Spare Parts Evaluations.
Our specialized focus on life sciences ensures that our commissioning protocols account for the unique demands of labs, cleanrooms, and manufacturing facilities, including critical environmental parameters, process utility validation, and data integrity. We partner with you to ensure a seamless transition from construction to fully operational, compliant facility. Our MEP and system experts assess the installation and operation of facility, utility, and process systems such as HVAC, BAS, packaging/filling equipment, high purity water systems, process/manufacturing equipment, and compressed air.
SPARK THERAPEUTICS: Genesis provided commissioning services for this 38,000 sf interior renovation, including R&D laboratories and gene therapy manufacturing spaces, ensuring critical systems performed as intended.
cGMP BIOTECHNOLOGY FACILITY: For a new 338,000 sf cGMP manufacturing facility, comprehensive commissioning of all systems (HVAC, utilities, process equipment) would be paramount for operational readiness.
BRISTOL-MYERS SQUIBB (Cambridge, MA): An 180,000 sf R&D laboratory and office space fit-out for a LEED Gold-Certified project would involve extensive system commissioning.
