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 F838-15a and Health Industry Manufacturers Association guidance documents.
- ASTM F838
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|FSV110||Filter Sterilization: Brevundimonas diminuta challenge||Add|
|FSV115||Filter Sterilization: Brevundimonas diminuta challenge, 142 mm disc||Add|
|FSV120||Filter Sterilization: Brevundimonas diminuta challenge, 47 mm disc||Add|
|FSV125||Filter Sterilization: Brevundimonas diminuta challenge, IV/syringe filters||Add|
|FSV130||Filter Sterilization: Bubble point/Integrity test/Diffusion||Add|
|FSV140||Filter Sterilization: Serratia Marcescens challenge, 10 in.||Add|
|FSV145||Filter Sterilization: Mycoplasma challenge for filters||Add|
|FSV720||Filter Sterilization: Hydrophobic filters requiring wetting (IPA), additional fee||Add|
FSV110 - Filter Sterilization: Brevundimonas diminuta challenge
FSV115 - Filter Sterilization: Brevundimonas diminuta challenge, 142 mm disc
FSV120 - Filter Sterilization: Brevundimonas diminuta challenge, 47 mm disc
FSV125 - Filter Sterilization: Brevundimonas diminuta challenge, IV/syringe filters
FSV130 - Filter Sterilization: Bubble point/Integrity test/Diffusion
FSV140 - Filter Sterilization: Serratia Marcescens challenge, 10 in.
FSV145 - Filter Sterilization: Mycoplasma challenge for filters
FSV720 - Filter Sterilization: Hydrophobic filters requiring wetting (IPA), additional fee
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 OutlineFor 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.