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3M™ Zeta Plus™ Encapsulated System Filter Capsule with VR Series Media

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With specific biological fluids, combined anion exchange and physical entrapment removal mechanisms provide an additional level of viral reduction

Quality release testing includes a media ion exchange capacity assay

BC25 Laboratory capsules and Scale-up capsules are ideal for selecting the best media grade using low challenge fluid volume

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Details

Highlights
  • With specific biological fluids, combined anion exchange and physical entrapment removal mechanisms provide an additional level of viral reduction
  • Quality release testing includes a media ion exchange capacity assay
  • BC25 Laboratory capsules and Scale-up capsules are ideal for selecting the best media grade using low challenge fluid volume
  • A range of scalable capsule sizes aids predictable performance at every stage of drug development – from early stage discovery to commercial production
  • Combined ion exchange and physical entrapment virus removal mechanisms provides added level of viral safety and validatable viral log reduction
  • Economical "bolt-on" separation technology as adjunct or pre-filter to other viral clearance steps provides an added level of validatable viral clearance and can replace or augment chromatography columns or function as prefilter to final virus removal mem
  • Viral log reduction
  • Provides orthogonal method of viral clearance

We designed the 3M™ Zeta Plus™ Encapsulated Series filter with VR Series Media to aid in the reduction of certain viruses from biological fluids. They provide viral reduction at high flow rates in scalable cartridge configurations. Backed by our quality control testing, these products are designed for applications in biological and pharmaceutical filtration.

The removal and/or inactivation of contaminating viruses from biotherapeutics is a regulatory requirement to help ensure final  product safety.
A range of scalable cartridge sizes and sanitary housings aids predictable performance
The removal and/or inactivation of contaminating viruses from biotherapeutics is a regulatory requirement to help 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.

Our Zeta Plus VR Series filter media contains 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 contaminants. 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 are designed for use in biological applications where virus reduction is essential. The effluent characteristics of this filter media have 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 and available a 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.

Learn more about 3M solutions for biopharmaceutical process development, manufacturing and process monitoring (PDF, 2.88 Mb)

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