AW Celite® NF

Ultra-high-purity diatomite filter aids 

AW Celite NF is our high-purity diatomite filter aid, ideal for: 

• Solid/liquid separation
• Produced in accordance with cGMP manufacturing practises
• USP-NF compliance

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 our stand-alone Lompoc plant in California, USA, 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 minimise differences in filtration processes that previously used food-grade diatomite filter aids.

Imerys AW Celite NF media is designed for solid/liquid separation in conjunction with a pressure filtration system. It’s available in a wide range of permeabilities, with the least-permeable grades capable of removing 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 programmes 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
• Documentation
• Quality
• Consistency
• Change control
• Certificate of analysis

These quality systems support reduced testing and other certification programs in which users can minimise 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

Our high-purity filter aids are supplied in a variety of packaging configurations, including non-bulk and semi-bulk. All non-bulk options address USP-NF and pharmaceutical GMP requirements.