High Purity Filtration/Clarification USP-NF (High Purity) grade diatomite filter aids for the biopharmaceutical and pharmaceutical industries
Imerys USP-NF 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 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 USP-NF Filter Aid (HPFA) specifically designed for blood plasma fractionation and a high-performance filter aid engineered for the clarification and harvesting of biological fluids.
Imerys AW Celite® NF Media is a high purity USP-NF diatomite filter aid for the biopharmaceutical, pharmaceutical, high purity chemical, and specialty beverage industries.
Harborlite® TV is high purity USP-NF perlite filter aid for the biopharmaceutical, pharmaceutical, high purity chemical, and specialty beverage industries.
LRA (Lipid Removal Agent)
LRA® media is intended for removal of lipidatious compounds, including endotoxin; it can be later extracted by pressure or vacuum filtration systems.
Imerys USP-NF grade and high purity 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 GMPs 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 manufacturing procedures and documentation practices 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 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 cGMP requirements.
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.