3M™ Zeta Plus™ BC Series Filter Capsule with SP Series Media

We designed 3M™ Zeta Plus™ BC Series Filter Capsules with SP Series Media for biological and small molecule pharmaceutical manufacturing applications where an optimized balance of throughput and particle removal efficiency is critical. These capsules, having the same media as production products, are ideal for assessing filtration media grades using low challenge fluid volumes.

Zeta Plus SP Series filter media is a mixture of high surface area inorganic particles, cellulose and a positively charged crosslinking polymer. The combination of filtration efficiency and throughput results from the balance between 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. Single layer formats are offered in our highest filter surface area, making them the preferred choice over double layer formats for hard particle removal and predominantly surface loading filtration applications.

The Zeta Plus™ BC 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 capsules and cartridges enables predictable performance at every stage of drug development from early stage discovery to commercial production.

Pharmaceutical Grade Product
The Zeta Plus™ BC Series Filter Capsules with SP Series Media are designed for use in the manufacture of biopharmaceutical, vaccine, blood fractionation, small molecule API drug substances, and food and beverages. 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.

Filtration Performance
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 as a result of a unique balance of secondary, tertiary and quaternary amines resulting in a relatively low anion exchange capacity. As such, Zeta Plus™ BC Series Filter Capsules with SP Series Media (PDF, 2.88 Mb) 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.

Scalable Single-use Capsules
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 2.5 m2 single layer media complete the single-use capsule line.

Specifications

Resources

Regulatory Data Sheet (1)

3M™ Zeta Plus™ SP Laboratory Capsules

Article Information Sheet (1)

3M™ Zeta Plus™ Activated Carbon (SP/SLP) Laboratory Capsules

Catalogs (1)