Advanced Separation Products for High Purity Liquids

High Purity Filter Media

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®, AW Celite®NF and MP²™ Harborlite® 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 CGMPs 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 CGMP 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 CGMP requirements. This includes compliance with:

• 21 CFR 211.94 (a)
  "Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements."
• 21 CFR 211.94 (b)
  "Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product."
• 21 CFR 177.1520
  Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces
• USP-NF 25 NF 120
  Cytotoxicity testing by the Elution Test

For bagged options, Tyvek represents a major advancement in filter aid packaging. Unlike the paper bags in which conventional diatomite is packaged, Tyvek is ideal for use in CGMP facilities.
*Tyvek is a register trademark of Dupont Corporation

Scanning electron micrograph of Celpure® 65 (2500x)	Scanning electron micrograph of MP2™ Harborlite®	Scanning electron micrograph of AW Celite Standard Super-Cel® NF (500x)