3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsule with VR Series Media
About the product
We designed the Zeta Plus™ Encapsulated System Scale-Up Filter Capsule 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.
Product details
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.
The 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 Filters 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 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.
- Combined ion exchange & physical entrapment virus removal mechanisms.
- High contaminant holding capacity for economical filtration and reliable particle reduction.
- With specific biological fluids, combined anion exchange and physical entrapment removal mechanisms provide an additional level of viral reduction
- Economical purification product as adjunct or pre-fi lter to other viral clearance steps.
- Full range of scaleable capsule and cartridge filter configurations that allows pilot testing and scale-up with the same materials that will be used in full-scale systems.
- FDA Drug Master File and USP Class VI Biological Safety that eases validation and regulatory submissions by providing vital documentation and traceability.
- Provides orthogonal method of viral clearance.
- Can replace or augment chromatography columns
- Self-contained, single-use disposable capsule and cartridge modules for reduced labor time for changeouts and elimination of cleaning validation.
- Quality release testing includes a media ion exchange capacity assay
- Tested and optimized for pharmaceutical and biological service.