High Purity Filter Media USP-NF and High Purity grade diatomite filter aids for the biopharmaceutical and pharmaceutical industries
Imerys high purity filter aids have been used to produce high purity pharmaceuticals for over 30 years. Today, our filtration media is produced and shipped from a state-of-the-art plant in Lompoc, California. This fully enclosed, dedicated facility produces USP-NF and High Purity Grade diatomite filter aids for the biopharmaceutical and pharmaceutical industries, including blood fractionation applications.
Imerys pharmaceutical filter aids are manufactured in a new, stand-alone, FDA registered plant on Imerys’ Lompoc, California, operations site. This plant was designed and built to produce filter aid components under a ‘state of control’ appropriate for the pharmaceutical and high purity chemical industries. The plant is equipped with dedicated facilities including:
- Warehouse with segregated storage for pharmaceutical components
- Water purification
- Chemical storage and preparation facilities
- Process control laboratory
Imerys Celpure® is a high-purity and high-performance filter aid engineered for the clarification and harvesting of biological fluids.
Imerys AW Celite® NF Media is a high purity, direct 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 required for conventional food grade Celite® filter aids.
Harborlite® perlite filter aids
Imerys MP2 Harborlite® media is the preferred choice where a high purity, USP-NF grade direct replacement is required for food-grade Harborlite® perlite filter aid.
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
- 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:
- Quality policies
- Identity testing
- Expiration dating and stability
- Specifications and test methods
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.