We designed Zeta Plus™ LA Series Filter Cartridges for pharmaceutical manufacturing applications where the most stringent organic and inorganic extractables requirements exist. The cartridges have a reduced potential for yielding false positives in product endotoxin testing resulting from 1,3 beta-glucan interference in LAL (Endotoxin) assays due to aggressive extraction of the cellulose fibers.
Zeta Plus™ LA Series filter media is a mixture of high surface area, inorganic particles, cellulose, and a positively charged crosslinking polymer. We designed these filters for the lowest organic and inorganic extractable levels of the 3M depth filter portfolio by aggressively extracting both the inorganic particles and 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-micronic particles through anion exchange, and larger particles by mechanical sieving.
We construct Zeta Plus™ LA Series Filter Cartridges from multiple lenticular cells of opposing media disks that are bonded together with molded edge seals, assembled with polypropylene seals between each cell, and then unitized with stainless steel bands. Cartridges and sanitary housings are available in 8", 12", and 16" diameter formats, which enable predictable scale-up to full scale production.
The Zeta Plus™ LA Series Filter Cartridges are specifically designed for use in the manufacture of biopharmaceutical, vaccine, blood fractionation and small molecule API drug substances. The effluent characteristics of the Zeta Plus LA Series Filter media has been tested following a number of protocols contained in the United States Pharmacopeia (USP) compendia.
The Zeta Plus LA Series filter media is specifically designed to have the lowest organic and inorganic extractable levels of the entire 3M depth filter portfolio. Stringent product extractable specifications are controlled, in part, by aggressively extracting both the cellulose fibers and filter aids prior to producing the filtration media. Due to the pre-extraction of the cellulose fibers, the LA Series filtration media has a reduced potential of yielding false positives in product endotoxin testing resulting from 1,3 beta-glucan interference in LAL assays.
Our 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 LA Series filter media comprises 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 balance of secondary, tertiary and quaternary amines resulting in a relatively low anion exchange capacity. As such, Zeta Plus™ LA Series cartridges are a good choice in applications where the pharmaceutical product is negatively charged and where product recovery may be of concern. By controlling the choice of raw materials and the formulation, a variety of filtration grades are produced that each have a balance of fine particle removal and throughput capacity.
The Zeta Plus™ LA Series cartridges are available with either single or dual layer media. A full range of scalable single-use laboratory and scale-up capsules enables predictable performance at every stage of drug development from early stage discovery to commercial production. 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.
Our filter cartridges and sanitary housings are available in 8", 12" and 16" diameter, with surface areas ranging from 650 cm² to 3.9 m² per cartridge, enabling predictable scale-up and full scale production for a large volumes.