1037 CLeaning Room Validation Consultancy Services

The Medical Technologies Innovation Facility (MTIF) is being established to support organisations in developing innovative medical technologies. The philosophy is to work with strategic partners to take innovations from bench to bedside. MTIF is in the process of building two facilities one on the Clifton campus of Nottingham Trent University and the second on the Boots Enterprise Zone (BEZ). Both facilities will contain clean rooms.

On the Clifton campus we have specified an ISO Class 6 clean room where the emphasis is on protecting the product rather than the patient as no materials produced at Clifton will be used in man.

The philosophy at BEZ is different with the emphasis on patient safety as products produced at BEZ will be used in clinical trials and BEZ may become an initial launch site for low volume, high value medical devices. In order to meet the regulatory requirements of our customers the three clean rooms at BEZ will operate to FDA class 10,000and MHRA Grade C specifications.

Our clean rooms are being validated for the following reasons:

• To ensure that the design of the facility is fit for its intended purpose; • To ensure that the facility, equipment and environment meets User Requirement Specifications (URS); • To ensure that the facility, equipment and environment meet defined regulatory requirements of FDA class 10,000 and MHRA Grade C; • To ensure that the facility, equipment and its environment function together as a system to meet defined standards. MTIF requires a specialist contractor to deliver a full validation programme from development of the URS through the design control phase to establishing the routine procedures for monitoring and control, ending with the establishment of procedures to identify and manage changes that constitute the need for cleanroom re-validation. The specialist contractor will be responsible for generating all protocols and reports, undertaking or supervising all validation activities including the production of Standard Operating Procedures ensuring compliance with the appropriate FDA, MHRA and ISO standards.

Our expectation is that the validation will be undertaken wherever possible and will be integrated with the commissioning activities of the clean room fabricator.

The Contractor will be available for the first regulatory authority inspection to present the clean room validation programme

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