- High purity pharmaceutical grade diatomite
- USP-NF compliance
- Produced in accordance with cGMP manufacturing practices
Specially treated diatomite, high-purity filter aids (HPFA) are used for solid/liquid separation in biotechnology and pharmaceutical applications. Imerys Celpure® diatomite is an HPFA specifically designed for the clarification and harvesting of biological fluids, including blood plasma fractionation.
Celpure® is produced at Imerys’ stand-alone, state-of-the-art Lompoc plant in California, US 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.
Harnessing the properties of diatomite
Diatomite is powdery, porous and non-metallic making it ideal for the high-specification needs of the pharmaceutical and biotech sector. It offers enhanced purity and filtration speed over conventional filter aids and enables the removal of microscopically small solids.
Celpure® diatomite is now the HPFA of choice in biotechnology and bio-pharmaceutical applications, including blood plasma fractionation and as a filtration-boosting process aid for harvesting and clarifying antibodies and proteins.
Celpure® provides superior and consistent quality to meet this need within this industry. It meets the pharmaceutical and biotech industries’ strict regulatory requirements.
Celpure® is available in USP-NF grade for use in cGMP processes.
Only Celpure® and USP-NF grade filter aids meet EMEA Guideline 410/01 Rev 2 and come with BSE / TSE free certification.
Celpure® USP-NF grade filter media is used to reduce endotoxin content in a microbial lysate in a lentiviral plasmid recovery process
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.