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AW Celite NF



Celpure Diatomite is a High Purity Filter Aid intended for critical applications in the API, high purity chemical, and pharmaceutical, biotech and veterinary applications. Celpure patented manufacturing process is a major advance in filter aid technology and produced in a standalone FDA approved facility. The process generates a media that surpasses conventional diatomite filter aids in purity, performance, regulatory support, and finished product consistency. Celpure is the ideal choice when developing new high purity processes with diatomite filter aid, and is available in USP-NF Grade for use in cGMP processes. Only Celpure and USP-NF grade filter aids meet EMEA Guideline 410/01 Rev 2 and come with BSE / TSE free certification.

Studies and field experience show that after replacing conventional diatomite filter aids with Celpure diatomite filter aids, extractable impurities are significantly reduced adding to more consistent processes and improved yields.

(Table 1)

Extractables Expressed as mg/kg of Filter Aid
  Celite Standard Super-Cel®
(Food grade)
Celpure® 300 (High Purity grade)
A1 84.1 nd*
Ca 52.5 nd
Mg 50.5 6.2
Fe 20.0 2.8
Zn 10.5 nd
Cu 0.8 0.6
Sb 0.6 nd
Mn 0.7 0.2
Cr 0.2 nd
*(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, 50oC.

The USP-NF Grade Celpure media was developed as a pharmaceutical cGMP alternative to Food codex diatomite filter aids to addresses the following cGMP needs that are unmet with Food codex diatomite filter aids:

  • Regulatory Support

  • Compendial standards

  • Purity

  • Manufacturing and process control

  • Packaging

For more information on the differences between USP-NF Grade Celpure and Food codex grades of diatomite see Diatomite Filter Aid in CGMP Parenteral Pharmaceutical Processing: A Regulatory Perspective - available on request by e-mailing info@pureprocess.eu.

Intended Use of Celpure Media

Celpure media is intended for solid-liquid separation in conjunction with a pressure filtration system. Celpure media is available in a wide range of permeabilities. The least permeable Celpure grades can remove submicron solids in filtration applications.

(Table 2).

Permeability and Particle Size Retention
Grade Permeability (Darcy) Solids Removed (micron)*
Celpure® 25 0.025 < 0.3
Celpure® 65 0.065 < 0.3
Celpure® 100 0.100 0.4
Celpure® 300 0.300 0.5
Celpure® 1000 1.000 1.5

Table 2. *Data is provided for comparison purposes only. Depending on the compressibility of the solids, the values may vary by more than an order of magnitude.

Specialists at Carl Stuart Ltd are available to assist you choose the more appropriate filter aid to meet your industry's regulatory demands.