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Point-of-Use Filtration of Pharmaceutical Waters


The quality of waters used in pharmaceutical production is prescribed by the US Pharmacopeia (USP), European Pharmacopeia (EP) and other standards setting bodies. Visit our page on Filters for Pharmaceutical Water Systems for more information on filters used in the treatment processes.

Point-of-Use Controversy

The quality of waters used in pharmaceutical production is prescribed by the US Pharmacopeia (USP), European Pharmacopeia (EP) and other standards setting bodies. Visit our page on Filters for Pharmaceutical Water Systems for more information on filters used in the treatment processes. Read more below, or go to the product selection table at the bottom of this page to review point-of-use filter options.

Point-of-Use Filters for Pharmaceutical Waters

Point-of-Use filter system for Pharmaceutical waters

Choosing the Right Filter

Sterilizing filters are usually 0.22 micron or 0.10 micron rated membrane based filters. The same pore size rating may also be used for POU water filtration. If a true sterilizing grade filter is used, it will be provided with a serial number for traceability and a quality certificate showing that the filter has passed all required quality inspections to assure its performance. Some operators, for cost reasons, may choose to use a grade that is less than ‘sterilizing grade’. Bioburden reduction filters can still perform at the same level as sterilizing grade filters of the same pore size rating, but may be made to slightly less demanding specifications. Each operator will choose the filters based on their filtration goals and assessment of the risk of process contamination.

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.

Validation

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

Critical Process Filtration has multiple filter options for removing bacteria and other microorganisms. To read more about these filters and their possible use in pharmaceutical water POU applications, click on one of the links below. Critical Process Filtration has created short explanations of how using POU filters can help assure product quality and safety.


Media Code Filter Media Filter Grade Cartridge Data Sheet Capsule Data Sheet Disc Filter Data Sheet Pore Sizes Available (µm) Features
PPS Double-Layered Asymmetric Polyethersulfone (PES) Membrane Pharmaceutical
0.03. 0.1, 0.22, 0.45, 0.65, 1.8, 1.0, 1.2 Asymmetric, hydrophilic PES membrane for high efficiency bioburden reduction and sterilizing filtration.
PNM Nylon 6,6 Membrane Pharmaceutical
0.1, 0.22, 0.45, 0.65 For bacteria removal in pharmaceutical and biopharmaceutical processing. - bioburden reduction and sterilizing filtration.

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.