LRA Lipid Removal Agent
- Unique Silicate Adsorbent
- Removal of lipids, lipoproteins and endotoxins
- Produced in accordance with cGMP manufacturing practices
LRA® Media has demonstrated adsorbent capabilities to remove a variety of unwanted impurities.
LRA® media is produced at Imerys’ Silicate plant in California, USA. The process generates a media that provides exceptional performance and finished product consistency.
LRA® media is intended for removal of lipidatious compounds and can be later extracted by pressure or vacuum filtration system.
LRA® meets the following cGMP requirements:
- Regulatory Support
- Manufacturing and process control
Imerys LRA is 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 cGMPs 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 Regulatory Support Packages 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
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.