Module 18 2021

Examples of processes not considered “substantial manipulation” (1394/2007/EC Annex I)

 Cutting  Grinding  Shaping  Centrifugation  Soaking in antibiotic or antimicrobial solutions

 Cell separation  Cell concentration  Purification  Filtering  Lyophilisation  Freezing  Cryopreservation  Vitrification

 Sterilisation  Irradiation

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TOPRA MSc Module 18: Drug Device Combinations and other Technology