GMP Cleanroom Facility for Medical Device Production

What did the client need? In a competitive market, Dermaroller set themselves apart with the quality of their microneedling products and that differentiation now extends to the environment in which they are produced. To prepare for an upcoming EU legislation change and to gear up for entering new markets, Dermaroller GmbH partnered with Connect 2 Cleanrooms (C2C) to upgrade its medical device production facility in Wolfenbüttel, Germany with a GMP grade D (ISO Class 8) cleanroom. The cleanroom supports the assembly process where the two main parts of the product are connected and then pouched for later sterilisation. Transfer hatches support the movement of product from early production stages, through the cleanroom for assembly and pouching, then onto the final packing stage. How did we help our client? We provided the technical expertise on the design elements required to achieve GMP guidelines. The panel system cleanroom uses Kingspan insulated Precision panels to provide a GMP-compatible flush finish and meets 70 air changes per hour at an air speed of 0.45m/s in the main area using HEPA filtration. The flooring is flush fitting coved vinyl and 36W LED panel light fittings provide the task lighting. How did our client benefit? Through an effective collaboration, Dermaroller’s cleanroom has an efficient layout facilitating their process flow. Dermaroller’s cleanroom production environment is compliant with GMP guidelines, proving to their notified body that they meet the needs required for medical device production.

For more information on GMP Cleanroom Facility for Medical Device Production talk to Connect 2 Cleanrooms Ltd