AW Celite® NF Diatomite filter aid
- Blood plasma fractionation
- Antibody and protein harvesting and clarification
- Process development (lab scale to commercialization)
- Solid/Liquid separation
- High purity pharmaceutical grade diatomite
- USP-NF compliance
- Produced in accordance with cGMP manufacturing practices
Imerys advanced mineral range of ultra-high purity Celpure® and AW Celite® NF grades – designed to support the production of pharmaceuticals and high purity products. AW Celite® NF media is the best choice where a high purity, USP-NF grade is required.
AW Celite® NF media is produced at Imerys’ stand-alone, state-of-the-art Lompoc plant in California, US and uses a patented manufacturing process. The process generates a media that surpasses conventional diatomite filter aids in terms of purity, performance and finished product consistency.
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
- Manufacturing and process control
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 9001 as well as the appropriate cGMPs and guidance documents.
These quality programs have been audited and accepted by both traditional pharmaceutical and biotechnology-based pharmaceutical producers.
This program enables the support of customer requirements for:
- Process control
- Change control
- Certificate of analysis
When appropriate, compendial testing is documented on the certificate of analysis.
Our Regulatory Support Packages are updated to align with cGMP requirements, guidance recommendations, and customer requirements.
The documents include information on:
- Quality policies
- Identity testing
- Expiration dating and stability
- Specifications and test methods
Imerys High Purity filter aids come in a variety of packaging configurations, including non-bulk and semi-bulk.
We offer a full range of custom formulation and technical and process support services to help you match the right mineral grade to your application requirement.