Pharmaceutical water generally refers to feeding water from utility systems such as scrubbers, autoclaves, and water for injection (WFI) systems.

However, since the quality of water sources varies greatly, only a correctly configured filtration system can ensure effective, safe, and smooth production.

Filtration is only one of several unit operations in the preparation process of pharmaceutical water. Other steps may lead to an increase in particles in the water, as both resin and activated carbon beds produce a powder.

pharmaceutical large volume parenteral

Our filtration goal

  • Pre-filtration

Removal of gums and particles to extend the life of the final filtration

  • Final filtration

Removal of particles, microorganisms, and endotoxins to comply with US Pharmacopoeia and other international standards.

Requirements by application

  • Pre-filtrationmust effectively remove most of the particles and colloidal impurities, requiring them to not only have a high dirt holding capacity, but also be able to maintain a high flow rate and high throughput during long-term use.
  • Finalfiltration must remove microorganisms and endotoxins while maintaining high flow rates and high throughput over long periods of time

The efficient combination

The ability of a positively charged filter to remove endotoxin is limited, and once its positive charge is saturated with endotoxin, it loses its ability to remove endotoxin.

An effective management method is to use two levels of filters in combination. The level of endotoxin is monitored between the two filters.

When endotoxin is detected downstream of the first-stage filter, the first-stage filter is removed and discarded, while the second-stage filter is moved to the first-stage location, and a new filter is installed in the second-stage location.

This approach allows for full use of the filter while ensuring endotoxin removal rates. The replacement of uncharged filters is determined by predetermined indicator limits, which can be maximum pressure drop, minimum flow rate, and maximum use time.

Recommended filters

Step of filtration Recommended filters
Pre-filtration PP pleated filter cartridge
Air/Gas Filtration Hydrophobic PTFE membrane pleated filter cartridge
Final filtration PES membrane pleated filter cartridge
Pharmaceutical water sterile venting
Pharmaceutical water point of use


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