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Filter Testing

Filter Testing

Filter Testing evaluates a filter’s ability to filter out microbial organisms of various sizes. This test allows manufacturers to determine membrane pore sizes and is an excellent lot release test. Test data can also be used as an effective marketing tool. Nelson Laboratories has significant experience using a wide range of microorganisms, working with multiple industries and performing tests in compliance with both the ASTM F838-05 and HIMA guidance documents.

Applicable Standards

  • ASTM F838
  • HIMA

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
FSV110 Filter Sterilization: Brevundimonas diminuta challenge 28 Add
FSV115 Filter Sterilization: Brevundimonas diminuta challenge, 142 mm disc 28 Add
FSV120 Filter Sterilization: Brevundimonas diminuta challenge, 47 mm disc 28 Add
FSV125 Filter Sterilization: Brevundimonas diminuta challenge, IV/syringe filters 28 Add
FSV130 Filter Sterilization: Bubble point/Integrity test/Diffusion 12 Add
FSV140 Filter Sterilization: Serratia Marcescens challenge, 10 in. 28 Add
FSV145 Filter Sterilization: Mycoplasma challenge for filters 49 Add
FSV720 Filter Sterilization: Hydrophobic filters requiring wetting (IPA), additional fee Add
FSV110 - Filter Sterilization: Brevundimonas diminuta challenge
TAT: 28 days
FSV115 - Filter Sterilization: Brevundimonas diminuta challenge, 142 mm disc
TAT: 28 days
FSV120 - Filter Sterilization: Brevundimonas diminuta challenge, 47 mm disc
TAT: 28 days
FSV125 - Filter Sterilization: Brevundimonas diminuta challenge, IV/syringe filters
TAT: 28 days
FSV130 - Filter Sterilization: Bubble point/Integrity test/Diffusion
TAT: 12 days
FSV140 - Filter Sterilization: Serratia Marcescens challenge, 10 in.
TAT: 28 days
FSV145 - Filter Sterilization: Mycoplasma challenge for filters
TAT: 49 days
FSV720 - Filter Sterilization: Hydrophobic filters requiring wetting (IPA), additional fee
Standard TAT not available for this product

Sample Specifications

FSV110: Minimum 1 filter
FSV115: Minimum 1 filter
FSV120: Minimum 1 filter
FSV125: Minimum 1 filter
FSV140: Minimum 1 filter
FSV145: Minimum 1 filter

Study Outline

For the Filter Test study, the organism is grown in a minimal media or other appropriate media depending on the required growth conditions, size ranges needed challenge organism and concentration. The test objective of a most severe bacterial challenge to the filter is met by the challenge conditions which include high pressure, high flow rates and a high bacterial concentration per cm2 of EFA (effective filtration area). The growth parameters, temperatures and media are adapted from the ASTM and HIMA methods.
 
Each test filter is challenged with a suspension of the specified challenge organism, usually B. diminuta for a 0.2 micron membrane, S. marcescens for a 0.45 micron membrane or Mycoplasma for a 0.1 micron membrane cultured to maximize the percentage of organisms capable of passing through the selected positive control filter (typically a 0.45 µm filter is used for B. diminuta, and other membrane sizes are used for other sized organisms).

Sufficient volume of this challenge suspension is used to provide the correct concentration of organism for the effective filtration area (EFA) of each filter (typically equivalent to at least 1 x 107 colony-forming units (CFU) per cm2 for B.diminuta; this may vary with other challenge organisms).

The challenge will be conducted at a high flow rate and a maximum differential pressure (typically 30 psig). The effluent will be collected and assayed quantitatively. Integrity testing is performed before and after the bacterial challenge procedure.

Please provide the effective filtration area of the filter when submitting samples.
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