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Junior filter cartridges for the Pharmaceutical and Biotechnology Industries

The Pall range of pharmaceutical grade Fluorodyne® II filters has been specifically developed for safe and reliable sterile filtration of a wide range of liquids. GMP Guidelines require that such filters should not affect the product by removal of active ingredients from it or by release of substances into it. Fluorodyne II filters have been designed to meet this requirement.

They show minimum adsorption of active ingredients and are manufactured and QC tested to ensure maximum cleanliness, to confidently meet industry standards and beyond. Absolute rated 0.2 µm Fluorodyne II P-grade filters are suitable for a wide range of applications including sterilisation of solutions containing very low concentrations of preservatives or proteins.

Fluorodyne II filters also offer exceptionally high flow rates. In many applications a Fluorodyne II filter can be used to replace another type of 0.2 µm rated sterilising grade filter of twice the size, offering savings in both filter and housing costs. Double-layer PVDF membrane, excellent chemical compatibility, high temperature rating and long steam life are among the many additional impressive features of these filters.

Pharmaceutical grade quality

Pall V Grade Quality is an assurance that the following conditions also apply:

• All components pass USP Biological Safety Tests and are listed in the Drug Master File submitted to the FDA.
• Finished product is sampled for microbiological challenge tests, as described in Pall Validation Guides and correlated to ASTM Standard Test Method F838-83, and meets the requirements of the FDA Guideline on Sterile Drug Products Produced by Aseptic Processing (June 1987).
• Every single filter cartridge is integrity tested by the Forward Flow method during manufacture. Results from Forward Flow testing for sterilising grade filters are continually validated against bacterial challenge.
• Filtrate quality meets required standards for the following parameters:
  • Oxidizable materials per USP tested by potassium permanganate.
  • Bacterial endotoxins per USP tested by limulus amoebocyte lysate (LAL)
  • Particulates
  • pH shift
• Each filter is identified with a batch and individual serial number by which every production stage can be traced. This also allows the user to record the full history of the filter's use for future reference.
• Samples taken during manufacture for steam autoclave testing.
• Manufactured according to GMP

Applications

• Solutions containing low concentrations of preservatives or proteins
• Aggressive liquids such as chemicals, solvents and alcohols*
• Cold and hot water systems
• Where PVDF is specified

* Fluorodyne II filters are compatible with a broad range of chemicals, however there are a limited number of applications where either Ultipor N-66 or Emflon filters are recommended. Pall's Scientific and Laboratory Services Department should be contacted for specific advice on compatibility.

Features and Benefits

• Inert filter media gives minimum adsorption of active ingredients and very low extractables.
• High flow rates and low pressure drop allow use of small systems reducing operating costs and product hold up.
• Correlated integrity test data enables user to test that the filter meets performance specification.
• Long steaming life offers low cost filtration.

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