The Medical Technology Innovation Facility ( MTIF) in Nottingham ( UK) is delighted to announce the imminent opening of its state of the art clean room suite . This new, class leading facility will allow organisations to develop their unique processes, produce innovative products for clinical trials under cleanroom conditions and access state of the art analytical capability.
MTIF are pleased to be offering cleanroom services, with three new cleanrooms available for rental. All cleanrooms are validated and maintained to ISO 14644 Class 6 and EU GMP Class C standards making them suitable for Medical Devices, Medicines and Combination Products. Flexible rental terms are available , including long term hires, and qualified cleanroom operators available, if required. The facilities allow customers a validated and managed space where they can develop their unique processes, produce innovative products for clinical trials under clean room conditions and access state of the art analytical capability.
As a custom-built facility, the cleanrooms offer approximately 50 sqm of floor area and come with additional dedicated storage, equipment preparation and offices spaces. Three dedicated laboratories are also in close proximity to the cleanrooms. One laboratory is equipped for ISO10993 in-vitro biocompatibility testing, with the two additional laboratories containing in-process, performance and pharmacopoeia testing equipment.
Dr Robert Reisel, MTIF Technical Director, speaking about the new facilities said:
“We look forward to welcoming clients to our new cleanroom facilities and supporting companies in developing their innovative medical devices, medicines and combination products. Our goal to provide a service unparalleled by other CROs and develop closer relationships between academia, industry and the NHS in order to get better products to patients quicker and more cost-effectively.”
MTIF is a new dual site Contract Research and Development organisation based in Nottingham, focussed on increasing the speed and efficiency of medical technology product development, through the provision of differentiated services within the life science sector. MTIF operates under an ISO13485:2016 certified Quality Management System ensuring that its customers can develop their products in compliance with EU MDR 2017/745, IVDR 2017/746 and FDA 21 CFR. Through strategic partnerships, MTIF will offer a fully integrated ‘bench to bedside’ turnkey service for the acceleration of innovative medical technologies.
Please contact Dr Max Bardwell to discuss your cleanroom needs.
07717 224731
This was written by Medilink EM Patron Nottingham Trent University, as part of the MTIF project, of which Medilink EM is a Partner Organisation.