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)].
Viral clearance is a measure of the capacity of the dedicated manufacturing process to inactivate or remove viruses. These studies involve viral spiking at intermediate stages in the process and then demonstrating the inactivation or removal of the virus during the subsequent stages.
Viral clearance studies involve:
- Identification of the process stage involving the inactivation or removal of viruses
- Verification of the scaled-down process
- Selection of viruses
- Verification of the performance of the process stage with viruses