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Pharmaceutical & Biopharmaceutical Water Filters

The water systems used to produce pharmaceutical waters include multiple treatment steps, including filtration. Filtration processes may include particle filtration & system prefiltration, trap filtration, tank vent filters, bioburden reduction and sterilizing filters. Some of these filtration steps are optional, but all are used in at least some facilities based on policies and conditions. For more detailed information on filters in pharmaceutical water systems, download our Application Guide.

Below is a schematic of a possible system for generating purified water with the additional step of distillation for producing water for injection. This basic system design is not required, but is similar to many operated in the pharmaceutical and biotech industry.

Pharmaceutical Water Standards

The United States Pharmacopeia (USP) and European Pharmacopeia (EP) have set well known standards for water used in pharmaceutical and biotech plants. Below is a table showing the requirements for the most commonly followed water quality standards – purified water (PW) and water for injection (WFI). The EP has a standard for "Highly Purified Water", but that standard has limited application and is seldom used.

  Parameter Unit USP EP
Purified Water
Total Organic Carbon (TOC) ppm C 0.50 0.5
Conductivity µS/cm@20°C -- <=4.3
µS/cm@25°C <=1.3 --
Nitrate (NOx) ppm -- <=0.2
Heavy Metals ppm as Pb -- <=0.1
Aerobic Bacteria CFU/ml <=100 <=100
Water for Injection
Total Organic Carbon (TOC) ppm C 0.50 0.5
Conductivity µS/cm@20°C -- <=4.3
µS/cm@25°C <=1.3 --
Nitrate (NOx) ppm -- <=0.2
Aerobic Bacteria CFU/100ml <=10 <=10
Bacterial Endotoxins EU/ml <=0.25 --
Bacterial Endotoxins IU/ml -- <=0.25

Particle Filtration and System Prefiltration

Removal of sediment and other suspended particles is critical to the efficient, cost effective operation of any membrane treatment system. Performed using depth filtration media, the initial particle trap filters and system prefilters preserve RO membrane performance and can reduce the frequency of RO membrane cleaning.

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Trap Filtration

Treated process water often passes through tanks containing activated carbon powder that may release small particles. Softeners and deionization tanks contain resin beads that may break down, fracture and release small particles. In both cases, filters are used to trap the particles and prevent their contamination of downstream treatment process steps. Again, depth filtration is most often used for this function.

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Bioburden Reduction and Sterilizing Filtration

Immediately after either an RO system or deionization tanks, membrane filters may be installed to capture water borne bacteria that may grow in the system and shed into the treated stream. Because chlorine must be removed from water entering most RO systems, there is no protection against the growth of any organisms that may become trapped in the RO system, so they can grow and be released downstream to contaminate further processes.

Filters to reduce the number of bacteria in a system or remove all bacteria (sterilizing filtration) may be installed at many locations in a facility. The most common installations are filters at the beginning of a distribution line or at the point of use for water for injection or purified water. Wash water or container rinse water may also be subjected to a sterilizing filtration process.

Bioburden ReductionSterilizing Filtration

Tank Vent Filters

Controlling the contamination of cell culture media, buffers, finished pharmaceutical solutions, or product ingredients while in storage is a critical process. The air around tanks is full of airborne bacteria and other organic contaminants and particulates that could harm your processes or finished products.

Particulate filtration for air may not be needed unless outside air is being brought directly into the facility for process use. Most facilities use HEPA filtration, but small volume air flows may be filtered for particulates using Critical Process Filtration cartridges.

Removing bacteria is the ultimate goal of vent filtration for pharmaceutical operations. Whether to sterile levels or only to significantly reduce bacterial load, Critical Process Filtration has membrane and media filters for the level of control you need.

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Critical Process Filtration has decades of experience with water filtration and water treatment. Critical Process Filtration has the filters to help your system run smoothly and reliably and deliver safe and compliant water for all your processes.

Contact Critical Process Filtration for more information.