The design of barrier facilities is a complex process and there are many potential risks associated with translating the design intent into the finished facility. Qualification, validation and commissioning, are required to ensure that the integrity and performance of each individual barrier, within the facility and the overall building, meets with both the clients and regulatory bodies required performance criteria.
Key factors that need to be considered in the qualification, validation and commissioning, of barriered facilities include:
Independent assurance that relevant biosafety and biosecurity issues have been considered and addressed throughout the construction programme.
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1. Carrying out a structured risk assessment to ensure that recognised standards and practices are being adopted. |
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2. Developing a commissioning plan, including the testing principles, and schedules. |
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3. Production of documentation demonstrating that the testing and verification of all relevant components, individual systems, integrated systems and validation of biological requirements has been carried out. |
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4. Minimising the risk of subsequent rework and building alterations, due to unforeseen deviations, changes, and/ or modification. Finalisation of the commissioning report and acceptance of its results. |
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5. A structured basis for the ongoing development of maintenance plans and associated protocols. |
The commissioning and validation process, following CCTech protocols for barriered facilities, is carried out via several documented stages, which run parallel to and compliment the design and construction project. The purpose of which, is the verification that the regulatory framework has been fully adopted within the completed facility.