All equipment and material, which are reused for processing further batches of products, are cleaned and sanitized or sterilized in order to avoid the contamination of subsequently produced batches by residual proteins and pathogens remaining on the material or equipment. The efficacy of the cleaning and sanitization/sterilization process is validated.

Virus Validation Studies

CSL Behring validates the manufacturing process for the effectiveness of both viral elimination and viral inactivation. All steps in virus reduction are corroborated through virus validation studies, which demonstrate and document the capacity of the manufacturing process to inactivate or remove viruses.