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Sterilizing Filtration


Sterilizing filtration is the most critical filtration process in any pharmaceutical or biopharmaceutical operation. It may be performed in intermediate process steps to allow downstream processes to operate efficiently. Of course, it is done during formulation and filling to protect patients and your brand.


Sterilizing filters are made using membranes that perform according to established industry standards. For pharmaceuticals, filters that pass the ASTM International standard "ASTM F838-05 - Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration" are designated as sterilizing filters.

Choosing the Right Filter

Sterilizing filters are usually 0.22 micron or 0.10 micron membrane based filters. They should be provided with a serial number for traceability and a quality certificate showing that the filter has passed all required quality inspections.

Sterilizing filters must remove bacteria, but also not adversely affect the solution. Assuring that outcome is part of the filter validation process.

Validation

Critical Process Filtration will assist in the testing and analysis of all of the filters in the system to assure the best, most cost effective performance and help document that performance for regulatory authorities. Visit our Services page for information on our Validation services, or click here to download a brochure that outlines those services.


Custom systems are designed for new applications and to solve challenges in existing processes. Critical Process Filtration will work with you to design, build and install a cost-effective system that delivers the results you need. Contact us or visit our custom filtration systems page for more information.

Application Summaries

Critical Process Filtration has multiple filter options for removing bacteria and other microorganisms. To read more about these filters, bioburden reduction and sterilizing filtration production, click on one of the links below. Critical Process Filtration has created short explanations of how removing bacteria is one step in assuring product quality and safety.

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

The filter media used for each process must, of course, be compatible with the fluids used in it. Contact Critical Process Filtration for assistance in determining the compatibility of filter media and support materials with your process.