When it comes to patient-specific blister packaging, the cleanroom environment, equipment cleaning and medicinal product stability must be considered together. The presentation explores three questions:
1. What cleanroom class is required for the respective activities?
2. How can it be demonstrated that the cleaning process reliably removes residues? And how is the stability of medicinal products assessed after deblistering and re-blistering, right up until administration?
3. The focus is on the technical challenges and the criteria for a traceable assessment.