水系统消毒的最佳温度是多少？85℃？80℃？还是65℃？
What is the Optimal Temperature forSanitizing Water Systems?
水系统消毒的最佳温度是多少?
Thermal sanitization is still the mostcommon method for keeping pharmaceutical water plants under microbiologicalcontrol. Many WFI storage systems are operated at continuous high temperatures.Pharmaceutical water systems are often only heated up cyclically to anelevated, germicidal temperature. In each case, the question arises as to theoptimal temperature. If the temperature is too high, it can cause materialdamage, whereas if it is too low, it may not be sufficiently germicidal.
热力消毒是制药用水控制微生物受控水平的最常用方法。许多 WFI 存储系统在持续高温下运行。制药用水系统通常只定期加热到高杀灭性能的温度。在每种情况下，都会出现最佳温度的问题。如果温度过高，可能会造成材质损坏，而如果温度太低，则可能消毒不充分。
In pharmaceutical plants, a sanitizing temperatureof 80 °C is often recommended for 'historical reasons'. This corresponds to thespecification of an earlier edition of the USP (US Pharmacopoeia) 'Temperaturesof at least 80° are most commonly used'.
在制药工厂，由于'历史原因'，消毒温度通常被定为 80 °C。这符合早期 USP （美国药典） '通常使用≥80℃'的标准。
However, this temperature can potentially negatively affect the durabilityof materials such as seals or membranes (as in reverse osmosis). Inaddition, rouging is to be expected at high temperatures in stainless steelwater systems. The hotter the temperature, the more rouging will occur.Overlaying the tank with nitrogen further increases the formation of rouging onSS316L surfaces.
然而，这种温度可能会对密封部件或膜（如反渗透）等材料的耐久性产生负面影响。此外，不锈钢水系统将在高温下产生红锈。温度越高，红锈越多。将罐体覆盖氮气后，还会进一步增加SS316L表面的红锈。
If a temperature of 80 °C can be harmful, the question arises as to whetherthis temperature is at all reasonable or prescribed in a binding GMP set ofrules.
如果温度80 °C 是有害的，那么会出现这样一个问题：此温度是否合理或是否在GMP 中强制规定？
A recent statement on this can be found inUSP chapter <1231>. In addition to the temperature and the type of germ,the exposure time is essential for germ killing. The kill rate is a function oftemperature, which is indicated by means of D-value. For example, the D-valuefor most microorganisms at 80 °C is five milliseconds. This means that in 5milliseconds the initial microbial load is reduced to one tenth. Furthermore,the sanitizing temperature of 80 °C is intended to ensure that the temperaturerequired to kill microorganisms is reached in all parts of a system for asufficiently long time. However, the USP considers temperatures as low as 65 °Cto be sufficient for sanitization. Of course, it must be ensured that the 65 °Cis also reached in the so-called 'cold spots' of a system. In a ring pipe, thereturn into the tank can be the coldest spot in the system, but it does nothave to be. Adherence to the 3D rule in the design of the system alsohelps to be able to sanitize safely with temperatures < 80°C.
最近关于这一点的声明可在 USP <1231>中找到。除了温度和微生物类型，曝热时间对于细菌杀灭至关重要。杀灭率是温度的函数，它通过D值表示。例如，大多数微生物在 80 °C 下的 D 值为 5 毫秒。这意味着在5毫秒内，微生物负荷减少到十分之一。此外，
80 °C 的消毒温度的目的是确保系统所有部分在达到杀死微生物所需的温度并维持足够的时间。但是，USP 认为温度低至 65 °C 足以进行消毒。当然，必须确保系统中所谓的'冷点'也能达到65 °C。在环形管道中，罐体回路可能是系统中最冷的位置，但也不一定。在系统设计中遵循3D 原则也有助于在温度＜80°C 下安全消毒。
The USP currently states 'Temperaturesof 65°-80° are most commonly used for thermal sanitization.'
USP现在指出'最常用的热力消毒温度是65-80℃'。
In the FAQs on pharmaceutical water, the USP refers to 60°C that must bereached on surfaces at the cold spot: '...to assure that all surfacesreach sanitizing temperatures greater than 60°C.' A sensible reduction inthe sanitizing temperature can therefore extend the durability of plasticcomponents in particular, reduce rouging and cut operating costs. This isespecially true when you consider that there are plants that store their WFI at 85°C in order to have a safety margin from the internally required 80°C at the'cold spot' due to the measurement inaccuracy of the temperaturesensor.
在关于制药用水的问答中，USP 指出冷点的表面必须达到 60°C：'...以确保所有表面的消毒温度大于 60°C。因此，合理降低消毒温度可以延长塑料部件的耐久性，减少红锈和降低运营成本。当你看到有些工厂将 WFI 存储在 85°C，以确保即便在温度传感器的测量不准确情况下在'冷点'处达到≥80°C的内部要求时，这一点尤其正确。
So what is the optimal sanitizingtemperature? For most generation plants and storage and distribution systems,the optimum is between 60 and 80°C. A temperature of 65 °C has proven to beeffective, but with a safety margin it can also be 70 °C - assuming asuitable plant design.
那么，什么是最佳的消毒温度呢？对于制备、存储和分配系统，最佳温度在 60 至 80°C 之间。温度为 65 °C 已被证明是有效的，但考虑上安全边际，也许是70 °C - 前提工厂设计是适当的。
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