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AW Celite NF

AW Celite® NF Diatomite filter aid

  • High purity pharmaceutical grade diatomite
  • USP-NF compliance
  • Solid/liquid separation
  • Produced in accordance with cGMP manufacturing practices

AW Celite® NF media is a high-purity pharmaceutical-grade 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.

AW Celite® NF media is produced at Imerys’ stand-alone, state-of-the-art Lompoc plant in California, US according to a patented manufacturing process. The process generates a media that surpasses conventional diatomite filter aids in terms of purity, performance and finished product consistency.

With the exception of the 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.

AW Celite® NF media is designed 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.

AW Celite NF media meets the following cGMP requirements: 

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

Quality

Imerys high purity pharmaceutical filter aids are produced with the most extensive quality system in the filter aid industry.

Production is structured to meet the requirements of ISO 9002 as well as the appropriate GMPs and guidance documents.

These quality programs have been audited and accepted by both traditional pharmaceutical as well as biotechnology-based pharmaceutical producers.

This program enables the support of customer requirements for:

  • Process control
  • Documentation
  • Quality
  • Consistency
  • Change control
  • Certificate of analysis

These quality systems support reduced testing and other certification programs in which users can minimize component testing per 21 CFR 211.84 (a) & (d).

When appropriate, compendial certification is documented on the certificate of analysis.

Our Regulatory Support Packages are continually updated to meet GMP requirements, guidance recommendations, and customer requirements.

The documents include information on:

  • Manufacturing
  • Quality policies
  • Extractables
  • Identity testing
  • Expiration dating and stability
  • Packaging
  • Specifications and test methods

Packaging

Imerys High Purity filter aids that are supplied as pharmaceutical components come in a variety of packaging configurations, including non-bulk and semi-bulk.

All non-bulk options address USP-NF and pharmaceutical GMP requirements.

We offer a full range of bespoke formulation and technical and process support services to help you match the right mineral grade to your application requirement.

Please contact us, we will be only too happy to help

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Health, Pharma & Biotechnology