We designed the Zeta Plus™ BC Series Filter Capsules with LP Series Media for manufacturing of biological products and have a reduced potential of yielding false positives in drug product endotoxin testing resulting from 1,3 Beta-glucan interference in LAL assays. Using the same media, BC25 Laboratory capsules are ideal for assessing filtration media grades using low challenge fluid volumes.
Our Zeta Plus LP Series filter media comprises of a mixture of high surface area inorganic particles, cellulose, and a positively charged crosslinking polymer. We designed it 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. Our BC25 laboratory capsule is ideal for optimizing the filtration performance for each drug process by effectively screening the available single layer media options. A scalable range of cartridges enables predictable performance at every stage of drug development from early stage discovery to commercial production. Pharmaceutical Grade Product We designed the Zeta Plus LP Series media for use in blood fractionation and biological 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. All components of construction including the filtration media have been tested to demonstrate compliance to USP Class VI Biological Reactivity, in-vivo. These results are documented in an available Regulatory Support File. The Zeta Plus LP Series media has a reduced potential of yielding false positives in product endotoxin testing resulting from 1,3 Beta-glucan interference in LAL (Endotoxin) assays. Our 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. Scalable Single-use Capsules The BC25 laboratory capsule with 25 cm² filter media is i