Solution
Pharmaceutical water and medical markets
Realizing the production of highly safe water by sophisticated membrane separation technology
About pharmaceutical water (medical water)
Pharmaceutical water is used for manufacturing and dispensing of pharmaceuticals and for cleaning of containers and equipment, and must meet high quality standards. Specifically, examples of pharmaceutical water include purified water and water for injection, which are subject to strict quality standards. For example, very low levels of bacteria and endotoxins (pyrogens) are required.
The quality of pharmaceutical water is assessed by indicators such as bacterial count, conductivity, and pyrogens, and must be appropriately controlled and monitored. It is important to always maintain a clean environment throughout the manufacturing process. Since this water is directly related to the efficacy and safety of pharmaceuticals, strict control and quality preservation are required.
What ultrafiltration membranes can do in the pharmaceutical water production process
Hollow fiber ultrafiltration membranes (UF membranes) are used as part of a pharmaceutical water production system to remove viable bacteria and pyrogens. Even in strictly controlled manufacturing processes, there is always the risk of contamination by bacteria and viruses. When a hollow-fiber ultrafiltration membrane (UF membrane) is installed in the final process, the membrane acts as the final filter that rejects bacteria and pyrogens to produce safe pharmaceutical water.
- ※1 Purified water refers to purified tap water that has been treated through distillation, ion exchange, reverse osmosis, ultrafiltration, or a combination of these processes.
- ※2 Water for injection is purified water made by distillation or ultrafiltration. These are defined in the Japanese Pharmacopoeia.
Separation membrane modules suitable for producing pharmaceutical water
Separation membrane modules of DAICEN MEMBRANE-SYSTEMS Ltd. are widely used in the production of pharmaceutical water. For example, the FS10 and FS03 modules have sanitary specifications and allow for easy maintenance. Among hollow fiber separation membrane modules, customers favor those equipped with T653 membranes that can reliably remove not only viable bacteria but also pyrogens.
Reliable filtration performance
| Module model | FS10-FUST653 |
|---|---|
| Molecular Weight Cut Off | 6,000 |
| Membrane material | Polyethersulfone |
| Endotoxin rejection rate | LRV 5 |
| ISO standards | 99.9% or more |
Reliability and extensive track record of success
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World-class* shipments
- DAICEN membrane modules are widely used in pharmaceutical plants not only in Japan but also overseas.
- ※Number based on our cumulative shipments
- ※Total results between FY 2002 and FY 2023
- ※Target models: FS10-FS(FC)-FUST653 and FS10-FS(FC)-FUS0353
- DAICEN membrane modules are widely used in pharmaceutical plants not only in Japan but also overseas.
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02
Our products are manufactured and assembled in Japan
- Membrane modules are manufactured at the Aboshi Works in Hyogo.
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Compliant with pharmaceutical standards in respective countries
- Our modules comply with the standards for pharmaceutical water in manufacturing processes of the Japanese Pharmacopoeia (JP), the European Pharmacopoeia (EP), and the United States Pharmacopoeia (USP).
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USP Class VI certified modules (two products: FS10-FC-FUST653 and FS10-FS-FUST653)
- Certified by USP CLASS VI, which is the most stringent of the USP standards to evaluate the biocompatibility of plastic materials intended for use as containers or accessories for parenteral preparations.
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Extensive experience and reliability
- Safety and reliability based on extensive experience and knowledge accumulated since product launch in 1985.
Difference from conventional methods
Advanced "Ultrafiltration method" that achieves both safety and sustainability
Conventional water for injection (WFI) used to be produced through a distillation process. A distillation system heats water to achieve both disinfection and purification at the same time. However, this process requires a large amount of energy, which is a problem. As a result, the separation membrane method for removing microorganisms and endotoxins (ultrafiltration method) has been established and conforms to pharmaceutical standards. This method is attracting worldwide attention as an energy-saving and sustainable alternative to distillation in advanced manufacturing.
Energy-saving without phase change
Separation membrane treatment can be performed by only depending on the pump operation, and therefore does not need phase change.
The ultrafiltration method realizes a greater energy-saving process than conventional distillation methods, which used to be the mainstream in the manufacturing process of pharmaceutical water.
●Vaporization method
Requires heating + cooling + fan/pump power
The distillation method uses the difference in boiling points of the components to vaporize only water with heating and to obtain distilled water without impurities.
●Membrane separation method
Basically the pump power only
A separation method that uses a separation membrane which has a filtration that allows substances smaller than the membrane pores to pass through the membrane. Treatment is performed by only depending on the supply pressure of the water pump.
Water for injection produced without distillation and established safety
The method of disinfection and purification by heating has been trusted for a long time, and is sometimes nostalgically referred to as the “distilled water myth.” On the other hand, there have been no reports of increased risk or poor accuracy when a membrane method is used instead. Water for injection (Cold Water For Injection: CWFI) that is treated without a distiller but with a separation membrane alone has been approved worldwide.
List of pharmacopoeia standards to which the ultrafiltration method (for CWFI) conforms
- Japanese Pharmacopoeia (JP)
- United States Pharmacopoeia (USP)
- European Pharmacopoeia (EP)
