制药用水系统消毒的最佳温度是多少?
那么最佳的消毒温度是多少呢?对于大多数制备、存储和分配系统而言，最佳温度在60到80°C之间。如果工厂经过适当的设计，65°C的温度已被证明是有效的，但为了确保安全边际，也可以设置为70°C。
Thermal sanitizationis still the most common method for keeping pharmaceutical water plants under microbiological control. In fact, for production plants - using ion exchange, osmosis, electrodeionization and ultrafiltration, it is the best method. Many WFI storage systems are operated at continuous high temperatures. Pharmaceutical water systems are often only heated up cyclically to an elevated, germicidal temperature. In each case, the question arises as to the optimal temperature. If the temperature is too high, it can cause material damage, whereas if it is too low, it may not be sufficiently germicidal.
热消毒仍然是控制制药用水系统微生物的最常用方法。事实上，对于生产工厂而言，采用离子交换、渗透、电去离子和超滤是最好的方法。许多WFI存储系统在连续高温下运行，制药用水系统通常只循环加热到较高的杀菌温度。在每种情况下，都会出现最佳温度的问题。如果温度过高，可能会造成材料损坏，而如果温度过低，则可能无法充分杀菌。
In pharmaceutical plants, a sanitizing temperature of 80 °C is often recommended for 'historical reasons'. This corresponds to the specification of an earlier edition of the USP (US Pharmacopoeia) "Temperatures of at least 80° are most commonly used".
在制药厂，由于“历史原因”，通常建议消毒温度为80°C。这与USP早期版本的规范相对应。“温度至少80°C是最常用的”。
However, this temperature can potentially negatively affect the durability of materials such as seals or membranes (as in reverse osmosis). In addition, rouging is to be expected at high temperatures in stainless steel water systems. The hotter the temperature, the more rouging will occur. Overlaying the tank with nitrogen further increases the formation of rouging on SS316L surfaces.
然而，这个温度可能会对密封或膜等材料的耐用性产生潜在的负面影响(如反渗透)。此外，不锈钢水系统在高温下也会产生红锈，温度越高，越容易产生红锈。在储罐中充氮气会进一步增加了316L不锈钢表面红锈的形成。
If a temperature of 80 °C can be harmful, the question arises as to whether this temperature is at all reasonable or prescribed in a binding GMP set of rules.
如果80°C的温度可能是有害的，那么问题就出现了，这个温度是否合理，或者是否是具有约束力的GMP法规中的规定？
A recent statement on this can be found in USP 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 of temperature, which is indicated by means of D-value. For example, the D-value for most microorganisms at 80 °C is five milliseconds. This means that in 5 milliseconds the initial microbial load is reduced to one tenth. Furthermore, the sanitizing temperature of 80 °C is intended to ensure that the temperature required to kill microorganisms is reached in all parts of a system for a sufficiently long time. However, the USP considers temperatures as low as 65 °C to be sufficient for sanitization. Of course, it must be ensured that the 65 °C is also reached in the so-called 'cold spots' of a system. In a ring pipe, the return into the tank can be the coldest spot in the system, but it does not have to be. Adherence to the 3D rule in the design of the system also helps to be able to sanitize safely with temperatures < 80°C.
最近关于这一点的声明可以在USP <1231>章中找到。除了温度和细菌种类外，暴露时间对杀菌也很重要。杀菌率是温度的函数，用D值表示。例如，大多数微生物在80°C时的D值为5毫秒。这意味着在5毫秒内，初始微生物负荷减少到十分之一。此外，80°C的消毒温度旨在确保在系统的所有部分达到杀死微生物所需的温度足够长的时间。然而，USP认为低至65°C的温度足以进行消毒。当然，必须确保在系统的所谓“冷点”也达到65°C。在环形管道中，回流到储罐的地方可能是系统中温度最低的地方，但它不一定是。在系统设计中遵守3D规则也有助于在温度低于80°C的情况下安全消毒。
The USP currently states "Temperatures of 65°-80° are most commonly used for thermal sanitization."
USP目前规定:“65°-80°的温度最常用于热消毒。”
In the FAQs on pharmaceutical water, the USP refers to 60°C that must be reached on surfaces at the cold spot: "...to assure that all surfaces reach sanitizing temperatures greater than 60°C." A sensible reduction in the sanitizing temperature can therefore extend the durability of plastic components in particular, reduce rouging and cut operating costs. This is especially 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 temperature sensor.
在制药用水的常见问题解答中，USP提到在冷点处表面必须达到60°C:“……确保所有表面达到超过60℃的消毒温度。”因此，合理降低消毒温度可以延长塑料部件的耐用性，特别是可以减少红锈并降低运营成本。考虑到温度传感器的测量不准确性，有些工厂将其WFI存储在85°C，以便在“冷点”处具有内部所需的80°C的安全边际时，降低消毒温度会极大降低成本。
So what is the optimal sanitizing temperature? 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 be effective, but with a safety margin it can also be 70 °C - assuming a suitable plant design.
那么最佳的消毒温度是多少呢?对于大多数制备、存储和分配系统而言，最佳温度在60到80°C之间。如果工厂经过适当的设计，65°C的温度已被证明是有效的，但为了确保安全边际，也可以设置为70°C。
撰稿人 | 漫漫制药路
责任编辑 | 胡静
审核人 | 何发
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