Harborlite® TV Perlite filter aid
- High purity FCC grade perlite
- Solid/liquid separation
- Produced in accordance with cGMP manufacturing practices
Harborlite® FCC-grade filter media such as our Harbolite® TV grades are the media of choice for use in Pharmaceutical applications.
Harborlite® media is produced at Imerys’ state-of-the-art plant in California, USA. The process generates a Perlite filter aid with high performance and product consistency.
Harborlite® TV media is intended for solid-liquid separation in conjunction with a pressure or vacuum filtration system. Harborlite®TV media is available in a wide range of permeabilities.
Harborlite®TV meets the following cGMP requirements:
- Regulatory Support
- Manufacturing and process control
- Modular production design—scalable as per market demand
Imerys 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 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 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
Imerys High Purity filter aids come in a variety of packaging configurations, including non-bulk and semi-bulk.
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.