To view all 0 products belonging to this category, click on the link here.

Celpure Diatomite

Celpure Diatomite is a High Purity Filter Aid intendedfor critical applications in the API, high purity chemical, and pharmaceutical,biotech and veterinary applications. Celpure patented manufacturing processis a major advance in filter aid technology and produced in a standalone FDAapproved facility. The process generates a media that surpasses conventionaldiatomite filter aids in purity, performance, regulatory support, and finishedproduct consistency. Celpure is the ideal choice when developing new highpurity processes with diatomite filter aid, and is available in USP-NF Gradefor use in cGMP processes. Only Celpure and USP-NF grade filter aids meet EMEAGuideline 410/01 Rev 2 and come with BSE / TSE free certification.

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

(Table 1).

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 apharmaceutical cGMP alternative to Food codex diatomite filter aids toaddresses the following cGMP needs that are unmet with Food codex diatomitefilter aids:

• Regulatory Support
• Compendial standards
• Purity
• Manufacturing and process control
• Packaging

For more information on the differences between USP-NF Grade Celpure andFood codex grades of diatomite see Diatomite Filter Aid in CGMP ParenteralPharmaceutical Processing: A Regulatory Perspective - available on request from submitting the General Enquiry Form.

Intended Use of Celpure Media

Celpure media is intended for solid-liquid separation in conjunctionwith a pressure filtration system. Celpure media is available in a wide rangeof permeabilities. The least permeable Celpure grades can remove submicronsolids in filtration applications.

(Table 2).

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 youchoose the more appropriate filter aid to meet your industry's regulatorydemands.

For more information on Celpure Diatomite please see the accompanying documentation.