Millipore Technical Publications |
 | TN- AN1033EN00 | |
Multi-Tier Approach to Assuring Virus Retention and Integrity of Viresolve Pro Devices | ||
| Lit No: | AN1033EN00 | |
| Year: | 2008 | |
| Manufacturers of biopharmaceuticals are required to characterize the ability of key process steps to clear viruses. Typically, the entire manufacturing process is qualified to attain a cumulative virus reduction factor, which significantly contributes to the documentation of virus safety. In many of these manufacturing processes, a virus retentive filter is utilized to achieve a robust and effective virus clearance step. The key to the implementation of virus filtration is the assurance of virus retention and device integrity. Millipore’s Viresolve Pro solution is based on a highly retentive parvovirus membrane, packaged in a range of devices, that is in-line with customers’ process development, validation and production stages. A critical aspect of the Viresolve Pro solution is to present users with an industry-leading level of virus clearance assurance by offering effective performance as well as integrity testing methods. This document provides a summary of our multi-tier approach to assuring virus filter performance and integrity, which comprises complementary steps taken by Millipore and the end user. Click the PDF above for the full document. | |
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