Life Sciences

FST can develop or review your project-specific quality requirements to ensure a plan that aligns your execution strategy with inspection and validation requirements including Food and Drug Administration (FDA) regulations. FST can tailor its inspection tracking software to provide real-time, value-added data reporting to your field team for performance reporting. FST has the expertise to conduct thorough and precise testing, ensuring equipment performs reliably under actual operating conditions while the staff focuses on its core responsibilities.  

FST’s project team is fully versed in the project’s requirements before work begins. FST may also support your staff and trades by providing training, orientation materials and staff as needed. We can complete the system-level impact assessments for the required scope and develop commissioning documentation and IOPQ Protocols as required for each system.  

FST ensures that construction materials are received, stored, handled as specified and documented to comply with validation and specification requirements. We also have staff throughout the USA that support source inspections and audits to verify supply chain performance.

FST verifies each phase, from procedures and personnel through visual and remote inspection procedures, through to the final acceptance and documentation process.

FST ensures that UHP equipment is installed and tested according to manufacturer-recommended practices and certifies UHP gas and liquid delivery system installations for safety and purity. FST may also commission gas systems in bulk processes, Ultrapure Water (UPW) and Deionized water (DI) systems. These protocols ensure that UHP systems in the life sciences industry maintain the purity and reliability required for sensitive applications, such as pharmaceutical manufacturing and biotechnology research.

We collaborate early and often to verify the status of installations to ensure the work is complete and ready for these final verifications as early as possible.

FST ensures a smooth handover at project completion. The TOP process includes a comprehensive turnover package delivered in a timely manner.

FST has industry-certified staff that can provide onsite training on new, existing, or retrofitted equipment to ensure the owner and owner’s staff can operate and maintain the system correctly and safely throughout its lifecycle. Training ensures that team members understand and adhere to the stringent regulatory requirements set by agencies like the FDA and EMA1 which will help avoid costly non-compliance issues and ensure patient safety.

Commissioning for new construction is a systematic process that documents each phase: design, installation and occupancy. It includes a thorough review of the design documents, including the Owner’s Project Requirements (OPRs), followed by onsite presence during installation, functional testing of operating systems and training of the owner’s personnel.

Over time, building performance degrades due to operational and occupancy changes. Existing building commissioning involves investigating, analyzing and optimizing building system performance through operational and maintenance improvement measures.

We provide commissioning services for the complete building enclosure for moisture, air, vapor and thermal control layers. These services encompass the subgrade waterproofing at the building’s foundation, the exterior walls and the roof systems to form a complete building enclosure.

We offer expert knowledge of up-to-date LEED qualifications and procedures to help you achieve project certification. Our team provides professional engineering services to fulfill LEED credits for Energy Atmosphere and Indoor Environmental Quality.