Ultrapure Water That Has Been Sterilized and Depyrogenated

Sterile

Generally, sterile water products are defined as having a bacterial count below 1 CFU/ml. Ultrapure water systems achieve a purification rate of over 99% after pre-filtration and fine filtration. Then, ultraviolet light with a wavelength of 253.7nm is used for sterilization, ensuring bacteria are completely within the equidistant intensity of the ultraviolet light, effectively killing bacteria with a sterilization rate of over 8D. Finally, a UF hollow fiber ultrafiltration membrane is used to filter out residual bacteria and proteins (substances that promote bacterial growth), resulting in a significantly sterile environment in the effluent. This ensures that the water quality meets the Chinese Pharmacopoeia 2000 standards for pharmaceutical preparations, with a bacterial count reaching level 10⁻³.

No Pyrogen

A pyrogen is a lipopolysaccharide, also known as an endotoxin, that constitutes the vapor membrane of Gram-negative bacilli. It is a biologically active substance produced by bacteria, microorganisms, yeast, viruses, etc. Chemically, it is not a single substance; the larger the molecular weight, the stronger the biological activity. When Gram-negative bacilli are destroyed, intracellular lipopolysaccharides are released, triggering the body's defense mechanisms, leading to elevated body temperature and even death. This reaction is known as pyrogen. Pyrogens are highly heat-resistant; dry heat at 121°C for 30 minutes cannot destroy their activity. Only dry heat treatment at 180-200°C for 30-60 minutes can deactivate their biological activity. For medical purified water (injection-grade pure water and kidney dialysis water, etc.) that comes into direct contact with blood, strict requirements are placed on pyrogen content, generally below 0.25 EU/ml. Ultrapure water systems combine membrane technology and high-powered sterile UV lamp technology. After RO membrane filtration removes most pyrogens, a 253.7nm UV lamp sterilizes the water, rendering highly active pyrogens inactive. Finally, an ultrafiltration membrane capable of filtering out residual pyrogens and proteins with molecular weights above 5000 is used, ensuring the final effluent meets the standards for bacteria-free and pyrogen-free water.