In general, you can wait as long as you want – at yourrisk. But it is advised to test as soon as practical for the following reasons;1) when stored, the water purity only degrades over time. Since PurifiedWater, Water for Injectionor the sterile waters are of such highpurity, the p...
USP的总有机碳(TOC)法规 USP要求对纯化水(Purified Water,PW)和注射用水(Water for Injection,WFI)进行TOC检测,USP <643>章对此有完整的说明。纯化水和注射用水的TOC限值设定为0.5 ppm。 2016年5月1日,USP <661>总章有了重大修订,此章标题重定为“ 塑料包装系统及其结构材料(PLASTIC PACKAGING SYSTEMS AND ...
In general, you can wait aslong as you want – at your risk. But it is advised to test as soon as practicalfor the following reasons; 1) when stored, the water purity only degrades overtime. Since Purified Water, Water for Injectio...
In general, you can wait aslong as you want – at your risk. But it is advised to test as soon as practicalfor the following reasons; 1) when stored, the water purity only degrades overtime. Since Purified Water, Water for Injection orthe sterile waters are of such high purity, the ...
However, certain sampling locations, such as sampling ports that are not used for manufacturing products or processes, do not represent the finished water quality where a Specification could be applied. In these locations, a two-tier approach (Alert and Action Levels only) could be applied. In ...
The finished water must meet all of the chemical requirements for Purified Water as well as an additional bacterial endotoxin specification. Because endotoxins are produced by the kinds of microorgan- G isms that are prone to inhabit water, the equipment and procedures used by the system to ...
2. What is the purpose of microbial Alert and ActionLevels for Purified Water and Water for Injection? 纯化水和注射水的微生物警戒限和行动限目的是什么? Alert and Action Levels are process control terms andshould be established at levels indicative of the water system trending outsideof its norma...
Water for Hemodialysis must meet all of the chemical requirements specified in the monograph as well as an additional bacterial endotoxin specification. The microbial limits attribute for this water is unique among the “bulk” water monographs, but is justified on the basis of this water’s ...
uspwater纯化compendialpurifiedpharmaceutical PurifiedWaterH2O18.02DEFINITIONPurifiedWateriswaterobtainedbyasuitableprocess.ItispreparedfromwatercomplyingwiththeU.S.EnvironmentalProtectionAgencyNationalPrimaryDrinkingWaterRegulationsorwiththedrinkingwaterregulationsoftheEuropeanUnionorofJapan,orwiththeWorldHealthOrganization'sGuide...
The commenter questioned why the sudden need to wash equipment/rinse with purified water? The commenter asked if there is evidence that trace amounts of minerals, biologicals, etc. that remain on the surface interact in a meaningful way with the compounded drugs. They see this as an ...