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.
熱消毒仍然是控制制藥用水系統(tǒng)微生物的最常用方法。事實(shí)上，對(duì)于生產(chǎn)工廠而言，采用離子交換、滲透、電去離子和超濾是最好的方法。許多WFI存儲(chǔ)系統(tǒng)在連續(xù)高溫下運(yùn)行，制藥用水系統(tǒng)通常只循環(huán)加熱到較高的殺菌溫度。在每種情況下，都會(huì)出現(xiàn)最佳溫度的問題。如果溫度過高，可能會(huì)造成材料損壞，而如果溫度過低，則可能無法充分殺菌。
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".
在制藥廠，由于“歷史原因”，通常建議消毒溫度為80°C。這與USP早期版本的規(guī)范相對(duì)應(yīng)。“溫度至少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，這個(gè)溫度可能會(huì)對(duì)密封或膜等材料的耐用性產(chǎn)生潛在的負(fù)面影響(如反滲透)。此外，不銹鋼水系統(tǒng)在高溫下也會(huì)產(chǎn)生紅銹，溫度越高，越容易產(chǎn)生紅銹。在儲(chǔ)罐中充氮?dú)鈺?huì)進(jìn)一步增加了316L不銹鋼表面紅銹的形成。
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的溫度可能是有害的，那么問題就出現(xiàn)了，這個(gè)溫度是否合理，或者是否是具有約束力的GMP法規(guī)中的規(guī)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.
最近關(guān)于這一點(diǎn)的聲明可以在USP <1231>章中找到。除了溫度和細(xì)菌種類外，暴露時(shí)間對(duì)殺菌也很重要。殺菌率是溫度的函數(shù)，用D值表示。例如，大多數(shù)微生物在80°C時(shí)的D值為5毫秒。這意味著在5毫秒內(nèi)，初始微生物負(fù)荷減少到十分之一。此外，80°C的消毒溫度旨在確保在系統(tǒng)的所有部分達(dá)到殺死微生物所需的溫度足夠長(zhǎng)的時(shí)間。然而，USP認(rèn)為低至65°C的溫度足以進(jìn)行消毒。當(dāng)然，必須確保在系統(tǒng)的所謂“冷點(diǎn)”也達(dá)到65°C。在環(huán)形管道中，回流到儲(chǔ)罐的地方可能是系統(tǒng)中溫度最低的地方，但它不一定是。在系統(tǒng)設(shè)計(jì)中遵守3D規(guī)則也有助于在溫度低于80°C的情況下安全消毒。
The USP currently states "Temperatures of 65°-80° are most commonly used for thermal sanitization."
USP目前規(guī)定:“65°-80°的溫度最常用于熱消毒。”
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.
在制藥用水的常見問題解答中，USP提到在冷點(diǎn)處表面必須達(dá)到60°C:“……確保所有表面達(dá)到超過60℃的消毒溫度。”因此，合理降低消毒溫度可以延長(zhǎng)塑料部件的耐用性，特別是可以減少紅銹并降低運(yùn)營(yíng)成本?？紤]到溫度傳感器的測(cè)量不準(zhǔn)確性，有些工廠將其WFI存儲(chǔ)在85°C，以便在“冷點(diǎn)”處具有內(nèi)部所需的80°C的安全邊際時(shí)，降低消毒溫度會(huì)極大降低成本。
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.
那么最佳的消毒溫度是多少呢?對(duì)于大多數(shù)制備、存儲(chǔ)和分配系統(tǒng)而言，最佳溫度在60到80°C之間。如果工廠經(jīng)過適當(dāng)?shù)脑O(shè)計(jì)，65°C的溫度已被證明是有效的，但為了確保安全邊際，也可以設(shè)置為70°C。
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