Pressure Interruptions (Stop/Start) During Virus Filtration: Assuring Safety Using Robust Process Technology and An Appropriate Risk Mitigation Strategy

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Following publications discussing the impact of pressure interruptions on the retention levels of virus filters, an increased focus is being placed on filter users’ own risk mitigation strategies. Users are increasingly requesting technical guidance and support with viral validation from filtration experts, as part of their overall product support package. This guidance document provides a high level of assurance to filter users by demonstrating how combining robust virus clearance technology with the use of standard operating procedures can assure a high level of virus safety.