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The High Purity filter aids supplied
by Advanced Minerals have been used to produce high purity
chemicals and pharmaceuticals for over 30 years. Today,
our filtration media is produced and shipped from a state-of-the-art
plant in Lompoc, California. This fully enclosed, dedicated
facility produces USP-NF and High Purity Grade diatomite
filter aids for the biopharmaceutical, pharmaceutical, high
purity chemical, and specialty beverage industries.
Our product line includes Celpure® and
AW
Celite®NF. We also offer pharmaceutical quality Harborlite perlite filter aids.
Manufacturing
Advanced Minerals’ filter aids are manufactured in
a new, stand-alone, FDA registered plant on Celite Corporation’s
Lompoc, California operations site. This plant was designed
and built to produce filter aid components under a "state
of control" appropriate for the pharmaceutical and
high purity chemical industries. The plant is equipped with
dedicated facilities including:
 Warehouse
with segregated storage for pharmaceutical components
Water
purification
Chemical
storage and preparation facilities
Process
control laboratory
Quality
Advanced Minerals’ filter media is produced with the
most extensive quality system in the filter aid industry.
Advanced Minerals’ filter aid production is structured
to meet the requirements of ISO9002 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
Documentation
Quality
Consistency
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:
Manufacturing
Quality
policies
Extractables
Identity
Testing
Expiration
dating & stability
Packaging
Specifications
& Test methods
Packaging
Advanced Minerals’ High Purity filter aids that are
supplied as pharmaceutical components come in a variety
of packaging configurations, including semi-bulk.
Non-bulk options include 5-15 kg lined poly drums as well
as 10-22.7 kg Tyvek* bags. All non-bulk options address
USP-NF and pharmaceutical GMP requirements. This includes
compliance with:
Products- High
Purity Filtration, Sorbents,
Gas-Liquid Chromatography, Sample
Request
Support- Application
Notes, SDS - NAFTA,
Data
Requests, Glossary
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