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 the integrity and barrier performance of each individual barrier within the facility and the overall building.
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.
1. Structured risk assessment to ensure recognised standards and practices are being adopted
2. A commissioning plan, including the testing principles, and schedules
3. Documentation demonstrating testing and verification of all relevant components, individual systems and integrated systems and validation of biological requirements
4. Minimising of risk of subsequent rework and building alterations due to unforeseen deviations, changes, and/ or modification finalisation of the commissioning report and acceptance.
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 a number of documented stages which parallel and compliment the design and construction project. With the purpose of verification that the regulatory framework has been fully adopted within the completed facility.
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