Production of sterile pharmaceuticals and medical devices in cleanrooms
Valicare offers you exactly the services you need to ensure the sterility of your cleanrooms for the manufacture and packaging of pharmaceuticals, sterile active ingredients, and medical devices.
Depending on the criticality of the process, different requirements from central regulations such as the EU GMP guidelines (e.g. Annex 1) and ISO standards such as DIN EN ISO 14644, VDI 2083, or DIN EN ISO 13485 apply. The aim of the defined limits for air purity, temperature, and humidity inside the room is to avoid product contamination through particles and germs. Possible sources of contamination can be personnel, machines, raw materials and media.
In addition to technical issues, GMP requirements for hygiene design must be considered in cleanroom design to minimize potential sources of contamination. For example, close attention must be paid to smooth, easy-to-clean designs for walls, ceilings, floors, and installations, and a suitable airlock and changing room concept must be established.
Valicare supports you in the creation or design review of the cleanroom concept suitable for your special process, taking into account the applicable standards and regulations. We advise you at an early stage during design qualification and, if desired, prepare the user requirement specification. We accompany you right through to plant acceptance and, if requested, also during operation.
