Updating international standards for pharmaceutical waters
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.
These additional control measures should prevent objectionable levels and types of microorganisms from being present in the water, based on for the water’s use.
USP is silent on a specific answer to this question.
And that’s not just good for your laboratory – that’s good for your customers.
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.
Water for Injection (WFI) Quality Water is the most suitable water available for producing cell culture media, reconstitution of biochemical reagents, and as a final rinse water for critical applications.
WFI Quality Water meets both EP and USP grade specifications and is 0.1µm sterile filtered at time of fill.
For pharma, the water treatment guidelines are based around pharmacopeias, of which the USP, European Pharmacopeia (EP), and Japanese Pharmacopeia (JP) are among the most influential.
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.