LRA Media
LRA Media
Our LRA Media is a specially formulated filter aid for the removal of lipidatious compounds, and it’s produced in accordance with cGMP manufacturing practices.
Our state-of-the-art lipid filtration aid
Our Lipid Removal Agent (LRA) Media is intended to act as a filter aid in the removal of lipidatious compounds. The highly effective agent can be later extracted by a pressure or vacuum filtration system.
- A unique silicate adsorbent
- Removal of lipids, lipoproteins and endotoxins
- Produced in accordance with cGMP manufacturing practices
Our LRA Media range demonstrates high adsorbent capabilities and is capable of removing a variety of unwanted impurities.
LRA Media is produced at our state-of-the-art silicate plant in California, USA. Our unique process generates media that provides exceptional performance and finished product consistency.
LRA meets the following cGMP requirements:
- Regulatory support
- Consistency
- Manufacturing and process control
- Packaging
Quality
Our 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
- Documentation
- Quality
- Consistency
- 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:
- Manufacturing
- Quality policies
- Identity testing
- Expiration dating and stability
- Packaging
- Specifications and test methods
