Cleanrooms, whenever you need them

Medace operates state-of-the-art, ISO-certified and GMP-ready cleanroom facilities. They are equipped, serviced and specifically designed to allow small scale manufacturing of Medical Devices and Cell based therapeutic products. We provide five ISO-7/ISO-8 and six Grade B and Grade C cleanrooms, all of them on a monthly basis. One Grade B cleanroom 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. With manufacturing demand still very irregular and depending on clinical outcomes, maintaining a maximum level of flexibility and low CAPEX investments is crucial to achieve long term success.

Medace B.V.

Kurt Gielen

Kurt Gielen

CBO

Details

Medace’s purpose is the acceleration of the development of proven (bio)medical concepts to production and application in humans. For this purpose Medace offers a full service cleanroom and R&D facility where customers (being academics or entrepreneurs) are guided in how to set up and develop the technical dossier needed for clinical validation whilst producing their clinical grade product. Medace works with (an EN ISO 13485:2016) certified quality and service package available for our customers on a use by need basis.

Target Customers