Updating international standards for pharmaceutical waters
The category known as ultrapure water (UPW) itself is used by end users in four main industries: life sciences, microelectronics, power generation, and specialty applications.Each industry’s definition of UPW is unique and their methods to produce this water, and requirements for materials of construction (piping, valves, storage tanks, etc.), vary.In this case, the two chemicals specified in the pharmacopoeial chapters are sucrose and 1,4- benzoquinone.Because of their unique and different chemical structure, sucrose and 1,4-benzoquinone challenge the bond-breaking and oxidation capability of the TOC measurement technology.Treated UPW that meets requirements for a power station would be unacceptable for a pharmaceutical plant.And purified water meeting pharma plant quality standards does not meet the stricter requirements found in the microelectronics industry.Since or the sterile waters are of such high purity, the passage of time does not do anything except potentially degrade the sample due to environmental, ambient, or container factors; and 2) water is typically not produced in batches, but rather it is usually purified, produced, and consumed continuously.The water may have had direct product impact or contact before any lab analysis is executed.
Because of the various uses of these waters, microbial requirements are not included in these monographs since this would unnecessarily burden some users with meaningless and/or inconsequential or inappropriate requirements, e.g. Microbial guidelines are provided under the informational chapter Alert and Action Levels are process control terms and should be established at levels indicative of the water system trending outside of its normal microbial control range.Delays in testing only increase the amount of potential product impact – in the event of a failed test.Community water systems in the United States use one of three additives for water fluoridation.These levels should be established at levels no higher than, and preferably lower than, those listed in based on the normal microbial performance trends in your water system.The purpose of Alert and Action Levels is to trigger additional, non-routine, rather than routine microbial control measures.