Clean Room


Healthcare establishments are special environments. Aspects like technical constraints, “medical culture” focused on patient related aspects, complex interface between the different departments and services, priorities due to the fact that the services cannot be interrupted, contribute to make hospital extremely complex organizations.

Our expertise in this challenging environment brings you added value in the following domains:

  • Hospital pharmacy
  • Radiopharmaceutical products
  • Sterilization processes
  • Biosafety aspects
  • Cell therapy and genic therapy


Specific requirements apply to all the above-mentioned domains.

PMSystem supports you by ensuring the interface between the user requirements and the engineering department, taking into consideration the regulatory aspect. So you can be sure that all projects will be performed, from a technical point of view, state-of-the-art and fulfilling the regulatory requirements.

  • Support with regulatory aspects and submissions
  • Implementation or optimization of Quality Management System
  • Support in the construction and upgrade of the manufacturing facility (clean room) for cytostatic production, radiopharmaceutical products, hospital pharmacy, sterilization center, ….
  • System qualification
  • Isolator qualification and validation of sterilization cycle
  • Training
  • Third - party audit