Applications Ultrapure water
ultrapure water used extensively in semiconductor industry; highest grade of upw quality. consumption semiconductor industry can compared water consumption of small city; single factory can utilize high-purity water @ rate of 2 mgd, or ~5500 m/day. use of upw varies; may used rinse wafer after application of chemicals, dilute chemicals themselves, in optics systems immersion photolithography, or make-up cooling fluid in critical applications. upw used humidification source cleanroom environment.
the primary, , critical, application of upw in front-end cleaning tools, when foundation of integrated circuit created. use cleaning , etching agent, impurities can cause product contamination or impact process efficiency (e.g. etch rate) must removed water. in chemical-mechanical polishing processes, water used in addition reagents , abrasive particles.
water quality standards use in semiconductor industry
it used in other types of electronics manufacturing in similar fashion, such displays, discrete components (such leds), , crystalline silicon photovoltaics; cleanliness requirements in semiconductor industry, however, stringent.
applications in pharmaceutical industry
a typical use of ultrapure water in pharmaceutical , biotechnology industries summarized in table below:
uses of ultrapure water in pharmaceutical , biotechnology industries
in order used pharmaceutical , biotechnology applications production of licensed human , veterinary health care products must comply specification of following pharmacopeias monographs:
british pharmacopoeia (bp): purified water
japanese pharmacopoeia (jp): purified water
european pharmacopoeia (ph eur): aqua purificata
the united states pharmacopoeia (usp): purified water
note: purified water typically main monograph references other applications use ultrapure water
it should noted ultrapure water used critical utility cleaning applications (as required). used generate clean steam sterilization.
the following table summarizes specifications of 2 major pharmacopoeias ‘water injection’:
pharmacopoeia specifications water injection
ultrapure water system validation process flow
ultrapure water , deionized water validation
ultrapure water validation must utilize risk-based lifecycle approach. approach consists of 3 stages – design , development, qualification , continued verification. 1 should utilize current regulatory guidance comply regulatory expectations. typical guidance documents consult @ time of writing are: fda guide inspections of high purity water systems, high purity water systems (7/93), emea cpmp/cvmp note guidance on quality of water pharmaceutical use (london, 2002) , usp monograph <1231> water pharmaceutical purposes
however other jurisdictions documents may exist , responsibility of practitioners validating water systems consult those. world health organization (who) pharmaceutical inspection co-operation scheme (pic/s) developed technical documents outline validation requirements , strategies water systems.
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