Ozone Sanitization of Pharmaceutical Water
Producing water of high chemical purity is not the challenge it once was, however it is often still difficult to maintain low levels of microbial contamination in these same nutrient waters. Systems today routinely output water of extremely low conductivity on the order of 0.06 micro siemens.
Only one alternative method for sanitization of stored and distributed pure water and ultra pure water has proven substantially equal to heat sanitization and that is the use of ozone, when properly applied.
However, it is often still a challenge to maintain low levels of microbial contamination in these same low nutrient waters. Tradition held that systems operating at temperatures over 165° F. and as high as 185° F. were most secure and hence most acceptable, however the cost of operation, was and is prohibitive, especially if cooler water was required in processing.
Only one alternative method for sanitization of stored and distributed pure water and ultra pure water has proven substantially equal to heat sanitization and that is the use of ozone, when properly applied.
Before implementing ozone one should explore the amount of ozone required, select a proper ozone concentration and type and size of ozone generator required, its proper application, handling and control, as well as safety issues and maintenance concerns.
Various system configurations, implementation methods has to be reviewed including actual projects installed over the past decade. It is obvious that the past and present experience of the industry demonstrates that the use of ozone as a sanitant is cost effective, reliable and uncomplicated.
Pure Water Standards in research facilities, the most common standards are defined by the American Society for Testing and Materials (ASTM) and the College of American Pathologists (CAP). ASTM and CAP provide specifications for reagent grade water into three categories. Type I is the highest grade.
In pharmaceutical water systems, specifications are covered by the United States Pharmacopoeia Standards (USP). The primary difference between WFI and purified water is the absence of bacterial endotoxin requirements for purified water, degree of system control and final purification techniques for bacterial removal.