New cleanroom rental project: Medicines and medical devices

Medical Technologies Innovation Facility has built three new cleanrooms 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

The Medical Technologies Innovation Facility expansion in progress

The UK's Medical Technology Innovation Facility (MTIF) has opened a new state of the art cleanroom facility in Nottingham, UK. MTIF is an integrated, dual-site medical device and advanced materials technology centre. The facility is split between two university campuses and is dedicated to increasing the speed and efficiency of medical technology product development through the provision of differentiated services within the life science sector.

Through strategic partnerships with many specialist companies, MTIF will offer a fully integrated 'bench to bedside' turnkey service for innovative medical technologies.

The facilities allow customers to develop their unique processes

MTIF's ISO13485:2016 certified Quality Management System will ensure its customers can develop their products in compliance with EU MDR 2017/745, IVDR 2017/746 and FDA 21 CFR.

MTIF will 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.

The new cleanrooms' flexible rental terms, including long term hires with qualified cleanroom operators, are available if required. The facilities allow customers to develop their unique processes, produce innovative products for clinical trials under cleanroom conditions and access state of the art analytical capability.

As a custom-built facility, the cleanrooms offer a range of room sizes. These vary from 45 sqm to 54 sqm, and are all specified to ensure the space operates to the ISO Class 6 and GMP C classification standards. In addition, dedicated storage, equipment preparation and offices complete each cleanroom suite.

Three dedicated laboratories are located in close proximity to the cleanrooms for ease-of-use. One laboratory is equipped for ISO10993 in vitro biocompatibility testing. Whereas the other two additional laboratories contain in-process, performance and pharmacopoeia testing equipment for that part of the process. Any or all of the laboratories also have the flexibility to be dedicated to a single client or single product.

Flexible rental terms include long term hires

Medical Technologies Innovation Facility brings together the laboratories, equipment, cleanrooms and experts necessary to take innovative medical technologies from bench to bedside.

Built on a research heritage, MTIF has expertise in four scientific domains:

  • Biomaterials
  • Cell, Molecule, Material Interactions
  • Smart Textiles
  • Surgical Robotics
  • Product Design and Prototyping
  • Hardware and Software Interfacing
  • Human Factors
  • Microbiology
  • Imaging

Product development capabilities can be applied to these scientific domains and many other areas of medical technology development.

MTIF has facilities specifically built for:

  • Clinical manufacture and scale-up
  • Micro-electromechanical and surface modification
  • Morphological and structural analysis
  • Biomaterials
  • Surgical simulation
  • Three dimensional knitting and wearables
  • Metrology and prototyping

Dr Robert Reisel, MTIF Technical Director 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."

The new centre aims to develop close relationships between academia, industry and the NHS to get better products to patients quicker.

"MTIF is here to help companies take innovations from bench to bedside," Reisel enthused.