Commissioning and validation are essential elements in a high containment facility construction process, providing an assurance that all relevant measures in the specification have been incorporated into the finished facility. The laboratory facility can then be considered capable of performing as required and in accordance with internationally recognised good practices.
Purpose
The construction of high containment facilities is a complex business and there are many potential risks associated with translating the design intent into the finished facility. Commissioning of a laboratory provides an assurance on capability of the facility to perform in accordance with BSL3/ BSL4 requirements. In addition, both commissioning and validation are important tasks because these activities not only ensuring the facility is capable of adequate performance, but also to minimise the risk of subsequent rework and building alterations, which can be both costly and disruptive to the program of work.
Benefits
The commissioning and validation of high containment facilities ensure and allow:
• Independent assurance that relevant biosafety and biosecurity issues have been considered and addressed in the facility construction
• Documentation demonstrating verification of all relevant components, individual systems and integrated systems
• Minimising of risk of subsequent rework and building alterations due to unforeseen mistakes, deviations, changes, and/ or modification
• A structured basis for the ongoing development of maintenance plans and associated protocols.
Features
The commissioning and validation process under the guidance of the DNV as Commissioning Agent is carried out via a number of structured and documented stages which parallel and compliment the design and construction project. The precise steps will vary according to customer requirements, but would normally include:
• Design verification based upon a structured risk assessment to ensure internationally recognised standards and practices are being adopted
• A commissioning plan, including the testing principles, and schedules
• Testing and verification of components, systems, integrated systems and validation of biological requirements
• Finalisation of the commissioning report and owner acceptance.
DNV’s role is to ensure all items required for inclusion in the commissioning process have been identified and recorded, together with the associated tests and check. We then make sure these are conducted satisfactorily with appropriate evidence of completion.
Overview of the DNV project stages in correlation with the BSL3 facility construction stages:
Process
Read more about the laboratory commissioning & validation process, or contact us if you are ready to request a quote.