Commissioning and
Operational Readiness

Commissioning is the systematic and documented approach to qualify, startup, and turnover a project, facility, building systems, and equipment to end-users. The results ensure that the design requirements, specification documents, and all stakeholder expectations are met and are properly documented through the commissioning system. During building and construction commissioning, the primary focus is placed on satisfying engineering requirements for the facility which were defined earlier in the project.

Operational readiness comprises the effort to develop all necessary maintenance standard operating procedures and to identify preventative maintenance activities and critical calibration requirements for each piece of equipment. This is especially critical in the highly technical sectors we primarily serve, such as biotechnology, agtech, pharma, and life sciences. It also includes the development of a comprehensive preventative maintenance and calibration program to be uploaded into our clients’ CMMS or CCMS systems.


Our core competencies

35 North commissioning competencies are specialized in the life sciences, biotechnology, pharmaceutical, and agricultural industries. We understand the need to follow good documentation practices and keep information traceability from the beginning of construction. Enhanced commissioning, as implemented by 35 North, can save downstream validation resources, time, and money for the owner.

35 North Biotechnology Commissioning and Operational Readiness Services Include Facilities and Utilities


  • Regular and Emergency Power
  • Generators, ATS
  • Flywheel and Battery UPS
  • Central Utility Plants
  • Chilled Water Systems
  • Hot Water / Steam Systems
  • Fire Protection Systems
  • HSE Systems
  • HVAC Systems
  • Building Automation Systems
  • Compressed Air
  • GMP Warehouses
  • Cold / Freeze Rooms
35 North Biotechnology Commissioning Services Core Competencies Includes Clean Utilities


  • Clean Rooms
  • Clean Steam Generators
  • Clean Steam Distribution Systems
  • Water for Injection Systems
  • Clean Gas Storage
  • Gas Mixing and Distribution Systems
  • Clean-in-Place (CIP) Skids
  • Steam-in-Place(SIP) Skids
  • Devitalization Systems
  • pH Neutralization Systems
  • Washers and Autoclaves
  • Depyrogenation
  • Cryofreezing / Liquid CO2
35 North Biotech Commissioning and Operational Readiness Services Include Process Equipment Fill Finish Equipment


  • Fermentation – Bioreactors
  • Media Prep
  • Centrifuges
  • Filtration Skids
  • Chromatography
  • Lyophilizers
  • Fill / Finish Equipment
  • Packaging Lines
  • HPV Chambers
  • Optical Coherence Chromatography
  • Environmental Chambers
  • Stability Chambers
  • Process Automation Systems
Commissioning Services include


  • Development of Impact and Risk Assessment
  • Development of Commissioning Master Plans
  • User Requirements Specifications (URSs)
  • Design Qualifications
  • Develop Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), equipment testing, and commissioning protocols


  • Execute FATs, SATs, Pre-Functional Testing (PFT), Functional Testing (FT), and Integrated System Testing (ST)
  • Perform all required BMS loop checks
  • Commission BMS System
  • Challenge physical interlocks and any alarming requirements
  • Verify and collect all equipment documentation, spare parts list, and preventative maintenance requirements
  • Identify critical calibration and maintenance requirements
35 North, Life Sciences Commissioning Services, Commissioning and Operational Readiness


  • Temperature mappings
  • Perform Terminal Air Balances
  • Challenge Emergency Power and UPS
  • Perform a comprehensive power loss and recovery test
  • Assure equipment and system training is provided
  • Integrate all commissioning information into an enhanced turnover package (ETOP) following good documentation practices
  • Develop preventative maintenance program, upload maintenance and calibration task list into the CMMS

For projects located in North Carolina, engineering services, such as commissioning, are provided by 35 Degrees North, PLLC, an affiliated company.

Let us put our expertise to work for you

We’re excited to partner with you! Our business consulting services and expertise in construction and project management are second to none. Our success is driven by the decisions we make, the policies we implement, and how our employees are trained.

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