Consultancy Services for Clean Room Design, Validation, and Qualification at Gene Therapy Innovation and Manufacturing Centre
Awarded 16 Feb 2022
About
The University of Sheffield awarded a contract to Complete Technical Solutions Limited for consultancy services relating to the design, validation, and qualification of clean rooms within the Gene Therapy Innovation and Manufacturing Centre.
The services covered tasks during the qualification and validation stages of the build completion of research and development facilities, including quality control and clean room areas in grades C and D environments, as well as process areas and supporting site operations such as major infrastructure and logistics.
The scope included preparation of a Qualification Requirement Matrix to track the validation lifecycle and support MHRA audits, validation assessments, user requirement specifications, validation plans, design document reviews, vendor document reviews, factory acceptance tests, site acceptance tests (commissioning), COTS installation/operational qualification protocols, installation qualification protocols, thermal mapping protocols (empty and loaded), operational qualification protocols, performance qualification protocols, and validation summary reports.
The contract involved approximately 50% site attendance, with regular visits throughout the construction period to ensure documentation standards and MHRA engagement, including attendance in a professional capacity for all MHRA interactions and assistance with the licence application process.
The contract value was AUD 280,124.
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