AW Celite® NF

Ultra-high-purity USP-NF pharmaceutical-grade filter aid

 Key benefits for AW Celite NF

• Ideal for solid/liquid separation: AW Celite NF is optimized for efficient solid-liquid separation in various filtration applications
• cGMP compliance: Produced in accordance with current Good Manufacturing Practices (cGMP), ensuring that our filter aids meet the highest safety and quality standards.
• USP-NF Compliance: AW Celite NF is fully compliant with USP-NF standards, making it the ideal choice for applications that require high purity and regulatory adherence.

Superior purity and performance

AW Celite NF serves as a high-purity, USP-NF compliant alternative to conventional food-grade Celite filter aids. This makes it an essential choice for pharmaceutical applications where purity and consistency are paramount. Produced at our dedicated facility in Lompoc, California, USA, AW Celite NF utilizes a patented manufacturing process that maximizes purity and performance beyond that of conventional diatomite filter aids. The unique process results in a filter media that maintains consistency and reliability, critical factors for manufacturers. 

With a manufacturing process that closely mirrors that of conventional Celite filter aids (excluding the acid washing step), AW Celite NF minimizes any discrepancies in filtration processes for facilities transitioning from food-grade diatomite.

Designed for efficiency

Imerys AW Celite NF is a specifically formulated USP-NF for solid/liquid separation when used in conjunction with pressure filtration systems. It’s available in a comprehensive range of permeabilities, including grades that effectively remove submicron solids, making it ideal for highly demanding filtration applications.

Compliance with cGMP standards

AW Celite NF meets rigorous cGMP requirements, providing:

• Regulatory support 
• Adherence to compendial standards 
• Proven purity 
• Robust manufacturing and process control 
• Comprehensive quality assurance 
• Packaging solutions

Our high-purity pharmaceutical filter aids are produced under the most rigorous quality systems in the industry. The manufacturing process adheres strictly to regulatory standards and guidelines outlined in ISO 9002, ensuring that all customer needs are met, including detailed documentation and quality control

Customer support and documentation

Imerys’ quality programs are designed to facilitate: 

• Process control 
• Detailed documentation 
• Consistent quality 
• Efficient change control 
• Certificates of analysis

These quality systems enable customers to streamline testing processes and comply with 21 CFR 211.84(a) and (d) requirements. When needed, compendial certifications are documented on the certificates of analysis.

Comprehensive Regulatory Support Packages

Our Regulatory Support Packages are routinely updated to align with evolving GMP requirements and customer specifications. These packages contain critical information regarding: 

• Manufacturing processes
• Quality policies
• Extractable substances
• Identity verification
• Expiration dating and stability studies
• Product packaging and specifications
• Test methods

Packaging options

AW Celite NF is available in a variety of packaging configurations, including non-bulk and semi-bulk options. All non-bulk packaging solutions comply with USP-NF and pharmaceutical Good Manufacturing Practice (GMP) requirements, ensuring the safe and effective delivery of our high-purity filter aids.

By choosing AW Celite NF, you are opting for the highest standard in diatomite filter aids, engineered for excellence and compliance in the pharmaceutical industry. Let us support your filtration needs with our commitment to quality and performance.