Harborlite® for health, pharma & biotech
A dedicated Harborlite range for pharmaceuticals
MP² Harborlite is our pharmaceutical-grade perlite filter aid. It replaces our food-grade Harborlite perlite filter aid, offering exceptional purity for pharmaceutical applications.
- High purity pharmaceutical-grade perlite
- Solid/liquid separation
- Produced in accordance with cGMP manufacturing practises
Our MP² Harborlite grades are the media of choice for the pharmaceutical industry. They are produced at our stand-alone Lompoc plant in California, in the USA, according to a patented manufacturing process. The process generates a media that surpasses conventional diatomite filter aids in terms of purity, performance and the consistency of your finished product.
With the exception of the acid washing purification step, the MP2 Harborlite perlite manufacturing process is similar to that of our conventional Harborlite perlite filter aid, which minimises differences in filtration processes.
MP2 Harborlite media is intended for solid-liquid separation in conjunction with a pressure or vacuum filtration system. MP2 Harborlite is available in a wide range of permeabilities, and meets the following cGMP requirements:
- Regulatory support
- Compendial standards
- Purity
- Manufacturing and process control
- Packaging
Quality
Our 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 programmes have been audited and accepted by both traditional pharmaceutical as well as biotechnology-based pharmaceutical producers.
This programme enables the support of customer requirements for:
- Process control
- Documentation
- Quality
- Consistency
- Change control
- Certificate of analysis
These quality systems support reduced testing and other certification programmes in which users can minimise 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:
- Manufacturing
- Quality policies
- Extractables
- Identity testing
- Expiration dating and stability
- Packaging
- Specifications and test methods
Packaging
All our high purity filter aids come in a variety of packaging configurations, including non-bulk and semi-bulk. All non-bulk options address USP-NF and pharmaceutical GMP requirements.
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