The 3M™ Zeta Plus™ Encapsulated Series Filter Capsule with SP Series Media is designed for bioprocessing, biological and small molecule pharmaceutical manufacturing applications where an optimized balance between throughput and particle removal efficiency is critical. The capsules have the same media as production products and are ideal for selecting media grades using low challenge fluid volumes.
Predictable Performance at Every Stage
The 3M™ Zeta Plus™ EXT Series Filter Capsule with SP Series Media comprises a mixture of high surface area inorganic particles, cellulose and a positively charged crosslinking polymer. This combination of filtration efficiency and throughput results from the balance among media porosity, depth and the relatively low-level anion exchange capacity: removing some negatively charged soluble contaminants and sub-micron particles via anion exchange, and larger particles by mechanical sieving. Dual layer media constructions result in high gradient porosity structures making the 3M™ Zeta Plus™ EXT Series Filter Capsule with SP Series Media an excellent choice for biological challenges where depth loading is critical to attain high throughput.
The 3M™ Zeta Plus™ EXT Series Filter Capsule with SP Series Media is ideal for optimizing the filtration performance for each drug process by effectively screening the breadth of available media options. A scalable range of single-use filters enables predictable performance at every stage of drug development from early stage discovery to commercial production.
Pharmaceutical Grade Product
The 3M™ Zeta Plus™ EXT Series Filter Capsule with SP Series Media is designed for use in the manufacture of biopharmaceutical, vaccine, blood fractionation and small molecule API drug substances. The effluent characteristics of the Zeta Plus SP Series filter media, capsules and cartridges have been tested following a number of protocols contained in the United States Pharmacopeia (USP) compendia. 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.
Zeta Plus SP Series filter media is a mixture of high surface area inorganic particles, high surface area cellulose and a crosslinking polymer resin. The polymer resin has a positive charge because of a unique balance of secondary, tertiary and quaternary amines resulting in a relatively low anion exchange capacity. As such, 3M™ Zeta Plus™ EXT Series Filter Capsule with SP Series Media products are a good choice in applications where the target product is negatively charged and product recovery may be of concern. By controlling the choice of raw materials and the formulation, a very large selection of filtration grades are produced, each with a unique balance of fine particle removal and throughput capacity.
The 3M™ Zeta Plus™ EXT Series Filter Capsule with SP Series Media grades are based on the combination of two distinct layers, or "zones," of single layer media where the upstream zone is more open than the downstream zone. This composite structure enhances the contaminant holding capacity when the optimum two-layer grade combination is selected. Larger particles are predominantly trapped in the upstream zone and smaller particles are trapped in the downstream zone, thereby extending service life.
A full range of scalable filter product configurations enables predictable performance at every stage of drug development from early stage discovery to commercial production. Specifically, the 3M™ Encapsulated System enables a completely single-use solution to process from 0.5 L to 2500+ L of liquid. The BC25 laboratory capsule with 25 cm2 filter media is ideal for media grade screening using small liquid volumes. The scale-up capsules with 170 cm2, 340 cm2 and 1020 cm2 media are designed for scale-up studies and low volume production. Production capsules having 0.23 m2 and 1.6 m2 of dual layer media complete the single-use capsule line.