Viral Clearance
In relation to pharmaceutical products and medical devices derived from raw materials of animal origin, for which the raw material may contain viruses that are dangerous to human health, the EU has introduced legislation requiring manufacturers of pharmaceutical products or medical devices to demonstrate the ability of purification and manufacturing processes to inactivate or remove viruses [EMA CPMP/BWP/268/95 (biopharmaceutical products) and ISO 22442-3 (medical devices)].