Commissioning,Biocontainment

Part 1: General Commissioning and Biocontainment Concepts

Whether your project is a new building or a small renovation, a diagnostics lab or a high-containment animal research facility, the process of commissioning can become an integral tool in support of applications required for many accreditation and certification organizations. Accreditation bodies such as the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) are concerned not only with regulatory accuracy and competency of staff, but also with ensuring a safe, functioning laboratory facility that has documented proof of operational accuracy. Because commissioning is a broad, comprehensive process that requires extensive coordination between the owner, safety officer(s), scientific staff, architectural/engineering (A/E) design team, and the contractor, it seems only logical to turn to the finalized commissioning plan as a starting point for documenting proof of process validations, confirmation of adequate safety standards, appropriate administrative procedures and functionality of the building systems in support of regulatory compliance. In order for a commissioning plan to assist in achieving accreditation or certification of a high containment laboratory, a better understanding is needed of exactly what is included in a commissioning plan, where the information is derived from, and which portions are appropriate for supplementing the accreditation application process.

This topic is extensive and therefore will be covered in four separate articles as follows:

Part 1: General Commissioning and Biocontainment Concepts

Part 2: Standard Operating Procedures (SOPs) for Commissioning and Compliance

Part 3: Commissioning for Operations and Maintenance Protocols

Part 4: Commissioning: Design from Construction to “Live and Hot”

Commissioning and Biocontainment
Commissioning is the process of ensuring that all building systems are installed and perform interactively according to the design intent, the systems are efficient and cost effective and meet the user’s operational needs, the installation is adequately documented and that the operators are adequately trained. It involves coordinating the efforts of the various parties involved in the design, construction, use and operation of a facility to achieve and optimally functional facility. It has the potential for long-term cost savings, which, theoretically, could result in owner’s electing to perform system commissioning with payback in mind.¹

An effective commissioning plan begins during the planning phase of a project. It is important to understand the cooperative structure of the design team and the ultimate responsibilities of each when including the commissioning agent early in the design process. The client must clearly communicate their needs as to the design intent, including any guidelines and regulatory requirements that must be adhered to. The A/E team is responsible for ensuring that the final design meets the needs of the users and is compliant with all regulatory bodies while at the same time developing a system matrix that clearly outlines the coordination requirements of each party. The commissioning agent is responsible for giving guidance regarding scheduling and testing requirements to ensure that the design is functional and can support intent.