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GMP Filter Aid

Manufacturing

At Pure Process we supply Advanced Minerals' filtration media. Advanced Minerals' filter aids are manufactured in a new, stand-alone, FDA registered plant on Celite Corporation's operations site in Lompoc, California. 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

Through Advanced Minerals, Pure Process can provide you with filter media, 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. These documents include information on:

• Manufacturing

• Quality policies

• Extractables

• Identity Testing

• Expiration dating and stability

• Packaging

• Specifications and Test methods

Packaging

Advanced Minerals' High Purity filter aids, 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. For more information on GMP Filter Aids please see the accompanying documentation.

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