Executed as a global exercise, cleanroom validation is a method of establishing documented evidence, with a high degree of assurance, that the manufacturing process will consistently yield a product of predetermined quality. If a manufacturer fails to execute a comprehensive equipment qualification, they may experience rising product failure rates, production inefficiencies, employee miscommunication due to incomplete standard operating procedures and, potentially, a loss of market share. This risk can be mitigated by performing an IQ/OQ/PQ on your cleanroom and equipment.

Cleanroom Commissioning is a systematic process of ensuring that a building performs by the design intent, contract documents, and the facility's operational needs. (Department of Energy). Due to the sophistication of cleanroom designs and the complexity of their associated systems, commissioning is necessary for GMP builds, but not automatically included as part of the typical cleanroom design and contracting process.

Building commissioning ensures that all systems within a building, including mechanical (HVAC and refrigeration), electrical, lighting, safety controls, plumbing, and specialized equipment operate according to specifications. This process verifies that the chosen products and systems meet the manufacturer's claims and are suitable for the intended project.

Commissioning is crucial not only before and during the initial occupancy, but also throughout the life of the building process to accommodate use changes and system wear. Continuous commissioning or periodic recommissioning is necessary to maintain operation in line with the original design intent and construction documents. This practice involves checking and optimizing systems, such as ensuring air flow in ventilation systems is unimpeded by clean filters for efficiency, comfort, and health.

The commissioning of a cleanroom unfolds through several distinct stages, each critical to certifying its operational efficacy and environmental regulation from inception to active use. Effective commissioning strategies typically render the following optimizations and improvements during the build process:

• Energy savings and persistence of savings
• Improved thermal comfort with proper environmental control
• Improved indoor air quality
• Simplified operation and maintenance documentation
• Improved system function that eases building turnover from contractor to owner
• Consistent system function when the building turns over from one operator to another

Terra's Commissioning Plans include ISO 4 — ISO 8 cleanroom commissioning services, as well as Biosafety Level 1–4 laboratories. The commissioning process begins at the conceptual phase of a project and extends through design and construction, continuing for at least one year post-construction to ensure thorough validation of building systems.

Starting early in the design phase to integrate commissioning requirements into the project, it's important to outline special requirements in bidding documents and select contractors familiar with the commissioning process.

• Coordinating both static and dynamic testing to confirm system performance.
• Concluding with comprehensive staff training on system operations and ongoing warranty monitoring.
• Evaluation of building envelope and interior finish materials
• Laboratory-specific process checks to ensure a holistic approach to building performance and sustainability.

Terra provides an end-to-end service model to its clients, encompassing both up-front solutions and recurring services that are tailored for longer-term risk management and procedural compliance. 

Up-front Services

• GMP Roadmaps: Create a strategic plan for achieving and sustaining GMP compliance.
• Risk Mitigation Strategies: Implement robust plans to minimize risks associated with operations.
• Standard Operating Procedures (SOPs): Develop detailed instructions for quality and consistency of core processes

Ongoing Support

• SOP Updates: Maintain compliance by adapting SOPs to new regulations and operational protocols.
• Recommissioning: Ensure equipment and systems are updated and calibrated to current needs.
• Shutdown Support: Facilitate planned maintenance activities to optimize system longevity and reliability

Certification of a cleanroom or processing equipment can be as simple as performing a smoke study or a HEPA filter leak test. Certification testing protocols often don’t account for variables that may affect the final environment. An IQ/OQ protocol accounts for all known variables, performs a deeper verification of the equipment, and integrates all documents into a single, comprehensive file.