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  6. 3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsule with ZB Series Media

3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsule with ZB Series Media

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Suitable for primary cell culture filtration or intermediate polishing applications in R&D, Process Development or manufacturing of recombinant protein drugs such as monoclonal antibodies

Made using cellulose fibres, diatomaceous earth and a binding resin that imparts a positive charge (quaternary amine), ZB grade media filters particles from process solutions through mechanical sieving and electrokinetic adsorption mechanisms

Wide range of filter pore sizes (0.1 to 4 µm) and a dual layer lenticular construction allows for optimizing filter throughput and filtrate quality

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Detalles

Aspectos destacados
  • Suitable for primary cell culture filtration or intermediate polishing applications in R&D, Process Development or manufacturing of recombinant protein drugs such as monoclonal antibodies
  • Made using cellulose fibres, diatomaceous earth and a binding resin that imparts a positive charge (quaternary amine), ZB grade media filters particles from process solutions through mechanical sieving and electrokinetic adsorption mechanisms
  • Wide range of filter pore sizes (0.1 to 4 µm) and a dual layer lenticular construction allows for optimizing filter throughput and filtrate quality
  • Scaleable single use filter portfolio enables using the same filtration platform process liquids volumes of 0.5 to 20,000 litres

Zeta Plus™ ZB series filter media is an advanced depth filter media designed to provide clarification of bioprocess, biological and pharmaceutical fluids. Zeta Plus ZB series filter media is composed of pre-extracted inorganic filter aid, cellulose and a resin system that imparts a strong positive charge to the filter matrix, aiding its adsorption of negatively charged contaminants.

3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsule with ZB Series Media is optimized for secondary polishing applications during filtration of mammalian cell harvest fluids, clarification of high protein concentration feed streams and for optimal protection of downstream sterilizing grade membrane filters3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsule with ZB Series Media are composed of inorganic filter aid, cellulose and a resin system that imparts a positive charge to the filter matrix. The single use format reduces the need for cleaning validation and minimizes filtration set up time for biopharma process development scientists.

3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsule with ZB Series Media consists of two distinct layers, or “zones” of filter media with the upstream zone more open than the downstream zone. This structure enhances the contaminant holding capacity of the filter media, since larger particles are trapped in the upper zone of the filter media and smaller particles are trapped in the lower zone, reducing premature plugging and extending service life.

3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsule with ZB Series Media is optimized for clarification of mammalian cell harvest fluids and for protection of downstream sterilizing grade membrane filters. Their strong positive charge provides enhanced reduction of negatively charged contaminants compared to a mechanical filtration mechanism alone. In solution cells, cellular debris, endotoxins, and nucleic acids (DNA, RNA) carry a negative charge. 3M's application of positive zeta potential to ZB filter media creates a filter matrix that enhances the capture of negatively charged contaminants for maximum filtration performance. The strong positive charge over a broad pH range makes these filters ideal for cell broth clarification and for protection of downstream membrane filters.

Regulatory Support
3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsule with ZB Series Media is manufactured in accordance with an ISO 13485 Registered Quality Management system.  All filter components success fully passed the USP <88> Class VI Biological Reactivity Tests. Each filter includes certificate of quality and, to ease validation and regulatory submission.  These filters are registered with the US FDA with a drug master file and a comprehensive regulatory support file is also available.

Grade Selection
The 3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsule with ZB Series Media is available in 6 grades. Figure below, is provided as a guide to proper grade selection based on nominal retention ratings and can be used in conjunction with the recommendations in Table below to determine the appropriate filter grade for your application. Operating conditions and the fluid being filtered impact retention performance. 3M recommends small scale pilot runs to confirm grade selection prior to scale-up. 3M's application engineering team can assist in grade selection as well as assist in on-site evaluations. Filter system optimization can also be conducted at 3M laboratory facilities.

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