|
The definition of pure water varies with its usage. Pure water for
reagent use may be totally useless for clinical needs. But regardless of
usage ozone is becoming more frequent in pure water treatment systems.
Pure Water Uses
Laboratories - Pure water is used as a solvent, in the preparation of
compounds, tissue cultures, culture medias, analytic work and rinsing of
labware.
Hospitals - In clinical laboratories pure water is used for washing
and cleaning, preparation of solutions for injectable, irrigation and
intravenous solutions, hemodialysis and dilutions. Water must be not only
pure, but also sterile and pyrogen-free.
Pharmaceutical Manufacturing - Water for Injection (WFI) is used as a
solvent in the preparation of parenteral solutions for injectable,
irrigation and intravenous solutions administered by injection. Purified
water is used for non- parenteral solutions and some bulk pharmaceutical
chemicals.
|
Ozone Sanitization of Pharmaceutical Water
Producing water of high chemical purity is not the challenge it once was,
and systems today routinely output water of extremely low conductivity on
the order of 0.06 micro siemens.
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.
|
