3M™ Zeta Plus™ VR Series Filter Cartridge, VR02 A6801, 50/Case, Restricted

The removal and/or inactivation of contaminating viruses from biotherapeutics is a regulatory requirement for helping to ensure final product safety. Zeta Plus depth filtration offers an economical approach to enhance the performance of other technologies for reduction of certain types of viruses. A range of scalable cartridge sizes and sanitary housings enables predictable performance at every stage of drug development from early stage discovery to commercial production.

Our Zeta Plus VR Series filter media comprises a mixture of high surface area inorganic particles, cellulose, and a positively charged crosslinking polymer. This positive charge enhanced depth filtration combines mechanical entrapment and anion exchange for improved removal of many negatively charged containments. Depth filtration with anion exchange capacity may help protect chromatography columns or function as a prefilter to a size exclusion virus removal membrane filter.

Pharmaceutical Grade Product The Zeta Plus™ VR Series Filter Cartridges and laboratory capsules and discs are designed for use in biological applications where virus reduction is desired or where protection of downstream virus removal filters is required. The effluent characteristics of the Zeta Plus VR Series Filter media has been tested following a number of protocols contained in the United States Pharmacopeia (USP) compendia. All components of construction including the filtration media have been tested to demonstrate compliance to USP <88> Class VI Biological Reactivity, in-vivo. These results are documented in an available Regulatory Support File.

The 3M Purification Inc. Quality Management System is approved by an accredited registering body to the ISO 9001:2008 and ISO 13485:2003 Quality Management Systems. The manufacturing process, quality controls and regulatory oriented compliance reports are documented in a Drug Master File on record with the FDA. Every manufacturing lot of Zeta Plus VR Series media is quality release tested for ion exchange capacity using a charged dye.