Zeta Plus™ LP Series filter cartridges are designed for manufacturing of biologicals and have a reduced potential of yielding false positives in drug product endotoxin testing resulting from 1,3 Beta-glucan interference in LAL assays. Filter cartridges and housings are available in 8”, 12”, and 16” diameter providing a full range of scale-up and production options.
Zeta Plus™ LP Series filter media comprises a mixture of high surface area inorganic particles, cellulose, and a positively charged crosslinking polymer. This media is designed for relatively low organic extractable levels by aggressively extracting the cellulose fibers. The combination of filtration efficiency and throughput results from the balance between 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. Pharmaceutical Grade Product The Zeta Plus™ LP Series filter cartridges are designed for use in blood fractionation applications. The effluent characteristics of the Zeta Plus LP Series Filter media has been tested following a number of protocols contained in the United States Pharmacopeia (USP) compendia. The Zeta Plus LP Series filter media has a reduced potential of yielding false positives in product endotoxin testing resulting from 1,3 beta-glucan interference in LAL (Endotoxin) assays. The media and cartridge products are manufactured globally in facilities with Quality Management Systems registered to ISO 9001 and 13485 to help ensure consistency in meeting product specifications. The manufacturing process, quality controls and regulatory oriented compliance reports are documented in a Drug Master File on record with the FDA. Product Design The Zeta Plus™ LP Series filter cartridges are available with single layer media. Zeta Plus cartridges are constructed from individual cells of Zeta Plus LP series filter media bonded using molded edge seals. The cells are assembled together with polypropylene ring seals under predetermined compression and unitized by three, 316 stainless steel bands. A full range of scalable filters enable predictable performance from laboratory to production. The BC25 laboratory capsule with 25 cm² filter media is designed for media grade screenin