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Controlling Bacteria for Medical Device Reprocessing

The most important question in choosing your bacteria filters is – how much of the bacteria do you wish to remove? Even though accepted standards do not require all bacteria to be removed, most facilities desire "bacteria free" water. So, most systems are designed to remove "all" bacteria. Read more about the standards and other questions to answer below, or go to the product selection table at the bottom of this page for bacteria filter options.

In all filter systems, the most important filter is the final filter. In this case, the bacteria filter. In the pharmaceutical industry, it is called a ‘sterilizing’ filter and is tested to assure it can remove all bacteria in water. The rest of the filters in the system protect that final (and most expensive) filter to maximize its useful life.

Sterilizing filters must remove ‘all’ bacteria. This pharmaceutical industry term describes filters that remove all bacteria during packaging of injectable drugs. The performance of the filters must be proven to the FDA before any drug can be made and sold utilizing the filters. Here is a short list of the major performance characteristics of sterilizing filters.

  1. Depending on the filter pore size rating, remove all bacteria larger than 0.22 microns or mycoplasma larger than 0.10 microns.
    1. 0.22 micron filters are documented based on testing using Brevundimonas diminuta bacteria.
    2. 0.10 micron filters are documented based on testing using Acholeplasma laidlawii mycoplasma.
  2. Be "integrity testable" with test pass/fail values correlated to the retention of bacteria or mycoplasma.
  3. Be proven safe for patients – meaning that all materials are at least FDA accepted. Some filter materials may also be tested according to USP standards for safe implantation in patients.
  4. Be proven to not affect the liquid being filtered or have their performance affected by filtration process factors.

Important note: While AAMI and FDA have an accepted standard for filters used in dialysis water, there are no filters specifically approved by the FDA for semi-critical device reprocessing under 510(k) rules.

For more information on this application, click on the link below to download an Application Summary

Choosing the Right Filter Media

The sterilizing filter is usually a 0.22 micron or 0.10 micron membrane based filter. The filter is provided with a serial number for traceability and is usually supplied with a quality certificate showing that the filter has passed all required quality inspections to assure its performance.

The table below shows the filter media in cartridge, capsule and disc filter configurations. We also have sanitary housings for filter cartridges. Click on the PDF Files in the appropriate location to download a data sheet for the filter media and configuration that fits your needs.

Media Code
Filter Media
Filter Grade
Cartridge Data Sheet
Capsule Data Sheet
Disc Filter Data Sheet
Pore Sizes Avail. (µm)
Features
BPS
Asymmetric Polyethersulfone (PES) Membrane
Biopharmaceutical
0.3, 0.1, 0.22, 0.45, 0.65, 1.8, 1.0. 1.2
Highly asymmetric, hydrophilic PES membrane in single-layer configurations for high efficiency, high flow rates and low product adsorption..

To estimate the number of filters you will need for your application, use our unique sizing tools.

Contact Critical Process Filtration if you have any questions, wish to discuss a specific application or want to learn more about any of our Products and Services. We look forward to hearing from you!