This section has a new structure with the subsections Heat, Chemistry and UV. In the former version all three procedures were described under the same heading.

The new version of USP <1231> recommends temperatures ranging from 65 to 80°C for thermal sanitisation. The previous version mentioned standard  temperatures of > 80°C. Now, sanitising temperatures that significantly exceed 80°C are not recommended, as these temperatures cause stress to materials and instruments while offering no additional benefit for the control of biofilm formation.

新版USP 1231推荐高温消毒的温度范围为65°C~80°C。旧版提到温度标准是> 80°C。现在,高温消毒明显超过 80°C已经不被推荐了,因为该温度对物料和设备造成浪费,然而对控制生物膜形成并不能提供任何额外的好处。

Other guidelines refer to similar temperatures. Table 1 shows the different opinions of the existing bodies:

Only a sanitising temperature of 80°C complies with all guidelines.

只有80℃热消才符合所有指南。
 Chemical Sanitisation化学消毒

Chemical methods typically employ ozone, peracetic acid, hydrogen peroxide or combinations thereof. In chemical sanitisation it is important to systematically take into account that biofilms cannot always be deactivated completely. For successful sanitisation it is essential to adequately distribute the disinfectant. Seals and boundary areas with less throughflow are problematic. Depending on the substance, disinfecting agents form strongly reactive peroxides or hydroxyl radicals with oxidative effect.

典型的化学方法包括臭氧、过氧乙酸、过氧化氢或者他们的组合。在化学消毒中,需要特别注意的是,生物膜往往不能被完全的消除。对于化学消毒,充分分配消毒剂尤为重要。没有通流经过密封和边缘的区域是有问题的。根据物质的不同,消毒剂通过氧化反应形成强反应性过氧化物或羟基自由基。

臭氧消毒提供了这些优势:使用254um紫外灯管可以帮助消除残留的臭氧并能长期在储罐内覆盖臭氧。灯管安装在供给侧,在水到达使用点之前将臭氧消除。分配系统可以定期关闭UV灯消毒,最好每天或者每周。这个信息是新版USP 1231新增的内容。它指出应该选择(适当的)循环频率以使生物膜不会形成。

这个系统的工艺验证要求消毒剂到达该系统的所有区域,并有足够的浓度的证据。这也包括使用点。而且,不仅仅化学剂的作用,在完成消毒后,它的消除也需要被适当的证实。

This section has been amended with the above-mentioned  new structure and the additional notes.这一章修订包括上述新的和附加的内容。
 UV sanitisation紫外消毒

It is pointed out that UV systems can be used to reduce bacteria, but not as the sole means of sanitising. Their use in combination with other measures is recommended to reduce sanitising frequencies.文件指出UV系统可以被用于减少细菌,但是不能作为消毒的唯一途径。建议与其它方法结合使用来减少消毒频次。
 Sanitisation procedures消毒程序

The purpose of sanitisation is to keep biofilm formation at an acceptable level. Regardless of whether chemical or thermal procedures are used, it must be demonstrated that the sanitising method is effective in all system areas. Specifically, this means that in chemical disinfection, evidence for the presence and absence of disinfecting agents must be given. Thermal systems require heat distribution studies. The decisive point is that hard-to-reach areas in the system also be sufficiently sanitised.

消毒的目的是保持生物膜形成在可接受的水平。不管是使用化学的还是热消的程序,应该证实消毒方法对系统的所有区域有效。尤其是,对于化学消毒,应该提供消毒剂作用和消除的证据。热消系统需要热分布研究。关键点是系统中最难达到的区域也能被很好的消毒。