GMP and ISO Cleanrooms, whenever you need them

Cleanroom Rental at Medace

Medace operates state-of-the-art, ISO-certified and GMP cleanroom facilities. They are equipped, serviced and specifically designed to allow small scale manufacturing of Medical Devices, Cell based therapeutic products and Advanced Therapy Medicinal Products (ATMPs). Medace offers cleanroom rental to innovative companies to enable clinical development of their product.

We’d be happy to discuss and help you accelerate your innovation to patients.

Cleanroom Classification

We provide five ISO-7/ISO-8, two GMP Grade B and four GMP Grade C cleanrooms, all classified according to ISO 14644. One of the GMP Grade B cleanrooms is built with a pressure sink allowing for ML-II work to be performed. All cleanrooms are equipped with break-out panels, allowing to move in large equipment. Each cleanroom comes with dedicated gowning rooms.

Flexible Cleanroom Rental

With manufacturing demand often still very irregular and depending on clinical outcomes, maintaining a maximum level of flexibility and keeping capital expenses low is crucial to achieve long term success. You can rely on the Medace cleanroom facility for short term cleanroom rental to manufacture your clinical product. Next to GMP and ISO cleanrooms the facility is equipped with Quality Control labs, monitored storage, equipment and development labs.

Product Capabilities

The cleanroom facility of Medace was designed as a multi-product facility directly from the start. Thereby enabling the manufacturing of several types of therapeutic and medicinal products. Including Advanced Therapy Medicinal Products (ATMPs) and implantable medical devices.

ATMPs are medicines for human use that are based on genes, tissues or cells. They offer ground breaking new opportunities for the treatment of disease and injury. Our GMP cleanroom infrastructure is purposely designed to enable safe, effective and more affordable development and manufacturing of these promising therapies.

Next to the infrastructure we have expert-teams onsite focused on ATMPs, biopharmaceuticals and Medical Device product development, who will work with you and external parties to get the best possible results.

Explore the Medace cleanroom facilities through our virtual tour: facilities

Location

The cleanroom facility is located in Maastricht, The Netherlands, the heart of Europe. And is located in the Brightlands Maastricht Health Campus, housing the Maastricht University, Maastricht University Medical Centre+ and many innovative medical companies. Both Belgium and Germany are less than 30 minutes away and the facility is close to multiple international airports.

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