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GMP Filter Aid



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


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


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.

GMP Filter Aids3 items found

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AW Celite NF AW Celite NF AW Celite NF Media is a high purity, direct replacement for conventional (Food Grade) Celite Diatomite filter aids. AW Celite NF media is the best choice where a high purity, USP-NF Grade direct replacement is needed for conventional food grade Celite filter aids. Enquire about this product View details
Celpure Celpure Celpure Diatomite is a High Purity Filter Aid intended for critical applications in the API, high purity chemical, and pharmaceutical, biotech and veterinary applications. Celpure patented manufacturing process is a major advance in filter aid technology and produced in a standalone FDA approved facility. Enquire about this product View details
MP2 Harborlite MP2 Harborlite MP2 Harborlite media is the preferred choice where a High Purity, direct replacement is needed for Food Grade Harborlite perlite filter aid. With the exception of the acid washing purification step, the MP2 Harborlite perlite manufacturing process is similar to that of conventional Harborlite perlite filter aid. This similarity produces a media that minimises differences in filtration processes. Enquire about this product View details