Advanced Minerals - AW Celite High Purity Diatomite Filter Media

High Purity Filter Media - Celpure - AW CeliteNF AW Celite NF Diatomite Filter Media

AW Celite NF Media is a High Purity, Direct Replacement for Conventional (Food Grade) Celite Diatomite Filter Aids AW Celite NF media is the best choice where a high purity, USP-NF Grade direct replacement is needed for conventional Food grade Celite filter aids. Other than the addition of an acid washing step, the AW Celite manufacturing process is similar to that of conventional Celite filter aids. This similarity produces a media that will minimize differences in filtration processes that previously used Food grades. Studies show that after replacing Food Grade Celite filter aids with AW Celite NF media, extractable impurities are significantly reduced (Table 1). Extractables Expressed as mg/kg of Filter Aid Celite Standard Super-Cel (Food grade) 84.1 52.5 50.5 20.0 10.5 0.8 0.6 0.7 0.2 AW Celite Standard Super-Cel NF (High Purity grade) 0.4 nd 7.4 1.4 nd 0.6 0.01 0.1 0.1

Al Ca Mg Fe Zn Cu Sb Mn Cr
*(nd) Below detectable limit

Table 1. Extractable analysis by ICP-MS except for Fe (colorimetric complex with 1,10-phenanthroline). Extractables expressed as mg/kg of filter aid extracted from 2-g samples incubated in 100-mL solutions. Solution: 10 mg/mL albumin, 50 mM sodium acetate, pH 4.3. Incubation: 4 h, 160 rpm, 50C. AW Celite NF media was developed as a pharmaceutical grade CGMP alternative to Food Grade Celite. AW Celite NF media addresses the following CGMP needs that are unmet with Food Grade diatomite filter aids: Regulatory Support Compendial standards Purity Manufacturing and process control Packaging For more information on the differences between AW Celite NF and Food grades of diatomite see Filter Aid in CGMP Parenteral Pharmaceutical Processing: A Regulatory Perspective and Replacing Food Grade Celite Media with AW Celite NF Media in CGMP Pharmaceutical Processes.

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Advanced Minerals - AW Celite High Purity Diatomite Filter Media For information on our production facility that serves the pharmaceutical industry, see High Purity Filter Media. Intended Use of AW Celite Media AW Celite NF media is intended for solid-liquid separation in conjunction with a pressure filtration system. AW Celite NF media is available in a wide range of permeabilities. The least-permeable AW Celite NF Grades can remove submicron solids in filtration applications (Table 2). Permeability and Particle Size Retention High Purity Grade AW Celite Filter Cel NF AW Celite 521 NF AW Standard SuperCel NF AW Celite 512 NF AW Hyflo SuperCel NF AW Celite 503 NF AW Celite 535 NF AW Celite 545 NF Permeability (Darcy) 0.10 0.30 0.30 0.40 1.0 1.6 3.0 4.0 Solids Removed (micron)* 0.5 1.2 1.2 1.5 2.0 3.0 3.5 4.5

Table 1. *Data is provided for comparison purposes only. Depending on the compressibility of the solids, the values may range by more than an order of magnitude. Packaging
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