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Celpure®

Our high purity, pharmaceutical grade diatomite is produced in accordance with cGMP manufacturing practices. It’s ideal for harvesting biological fluids, including blood plasma fractionation.
Celpure

Diatomite filter aids for harvesting biological fluids 

Our specially treated diatomite High-Purity Filter Aids (HPFAs) are used for solid/liquid separation in biotechnology and pharmaceutical applications. Our Celpure diatomite range is an HPFA specifically designed for the clarification and harvesting of biological fluids, including blood plasma fractionation.

Celpure is produced at our stand-alone, state-of-the-art Lompoc plant in California, US. The process generates a media that surpasses conventional diatomite filter aids in terms of purity, performance and the consistency of the finished product.

Diatomite is powdery, porous and non-metallic, making it ideal for the high-specification needs of the pharmaceutical and biotech sector. It offers enhanced purity and filtration speed over conventional filter aids and enables the removal of microscopically small solids.

Celpure diatomite is now the HPFA of choice in biotechnology and bio-pharmaceutical applications, including blood plasma fractionation and as a filtration-boosting process aid for harvesting and clarifying antibodies and proteins.

Celpure provides a superior and consistent quality to meet this need within this industry. It also complies with the pharmaceutical and biotech industries’ strict regulatory requirements.

Celpure is available in USP-NF grade for use in cGMP processes, and only Celpure and USP-NF grade filter aids meet EMEA Guideline 410/01 Rev 2 and come with BSE/TSE free certification.

All 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 9001 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
  • Change control
  • Certificate of analysis

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Celpure® USP-NF grade filter media is used to reduce endotoxin content in a microbial lysate in a lentiviral plasmid recovery process
Celpure® USP-NF grade filter media is used to reduce endotoxin content in a microbial lysate in a lentiviral plasmid recovery process

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. More details available from our download center.

The documents include information on:

  • Manufacturing
  • Quality policies

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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