Imerys (also called Advanced Minerals) is the world’s leading supplier of high purity diatomite filter aids as well as silica and silicate sorbents. Our products are manufactured in a state of the art plant and tested to meet the most stringent quality standards.
High Purity Filter Media
The High Purity filter aids supplied by Imerys have been used to produce high purity chemicals and 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, pharmaceutical, high purity chemical, and specialty beverage industries.
Our product line includes Celpure® and AW Celite®NF. We also offer pharmaceutical quality Harborlite perlite filter aids.
Imerys filter aids are manufactured in a stand-alone, FDA registered plant on the Imerys operations site in Lompoc, California. 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
Chemical storage and preparation facilities
Process control laboratory
Imerys’ high purity filter media is produced with the most extensive quality system in the filter aid industry. Imerys’ filter aid production is structured to meet the requirements of ISO9002 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:
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:
Expiration dating & stability
Specifications & Test methods
Imerys’ High Purity filter aids that are supplied as pharmaceutical components come in a variety of packaging configurations, including semi-bulk.
Non-bulk options include 5-15 kg lined poly drums as well as 10-22.7 kg Tyvek* bags. All non-bulk options address USP-NF and pharmaceutical GMP requirements. This includes compliance with:
21 CFR 211.94 (a)
“Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.”
21 CFR 211.94 (b)
“Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.”
21 CFR 177.1520
Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces
USP-NF 25 NF 120
Cytotoxicity testing by the Elution Test
For bagged options, Tyvek represents a major advancement in filter aid packaging. Unlike the paper bags, in which conventional diatomite is packaged, Tyvek is ideal for use in GMP facilities.
*Tyvek is a registered trademark of Dupont Corporation
Application Specific Benefits
First company to manufacture high purity diatomaceous earth
Meets stringent quality standards
Follows USP-NF and pharmaceutical GMP requirements
Variety of packaging options
For more information go to www.advancedminerals.com
To find out how our products can help your products and processes please contact us