欧盟GMP附录1，对消毒剂的要求解读

蒲公英

Disinfection（消毒）

4.36 The disinfection of cleanrooms is particularly important. They should be cleaned and disinfected thoroughly in accordance with a written programme. For disinfection to be effective, prior cleaning to remove surface contamination should be performed. More than one type of disinfecting agent should be employed to ensure that where they have different modes of action and their combined usage is effective against all bacteria and fungi. Disinfection should include the periodic use of a sporicidal agent. Monitoring should be undertaken regularly in order to assess the effectiveness of the disinfection program and to detect changes in types of microbial flora (e.g. organisms resistant to the disinfection regime currently in use). Cleaning programs should effectively remove disinfectant residues.

洁净室的消毒尤为重要。应按照书面程序彻底清洁和消毒它们。为了使消毒有效，应事先进行清洁以去除表面污染。应该使用一种以上的消毒剂，以确保它们具有不同的作用方式，其组合使用应对所有细菌和真菌有效。消毒应包括定期使用杀孢子剂。应该定期进行监测，以评估消毒程序的有效性，并发现微生物菌群类型的变化（例如，对当前使用的消毒方案具有耐受性）。清洁程序应有效去除消毒剂残留。

4.37 The disinfection process should be validated. Validation studies should demonstrate the suitability and effectiveness of disinfectants in the specific manner in which they are used and should support the in-use expiry periods of prepared solutions.

消毒工艺应经过验证。验证研究应证明消毒剂以指定使用方式下的适用性和有效性，支持所制备溶液的使用效期。

4.38 Disinfectants and detergents used in Grade A zone and Grade B areas should be sterile prior to use (disinfectants used in Grade C and D may also be required to be sterile). Where the disinfectants and detergents are made up by the sterile product manufacturer, they should be monitored for microbial contamination. Dilutions should be kept in previously cleaned containers and should only be stored for defined periods. If the disinfectants and detergents are supplied “ready-made” then results from certificates of analysis or conformance can be accepted subject to successful completion of the appropriate vendor qualification.

A级区和B级区中使用的消毒剂和清洁剂在使用前应无菌（C级和D级使用的消毒剂也可能要求无菌）。如果消毒剂和清洁剂是由无菌产品生产商配制的，则应对其进行微生物污染监测。稀释液应保存在已清洁的容器中，并且只能在效期内贮存。如果消毒剂和清洁剂是“即开即用”的，则在成功完成相应供应商确认的前提下，可以接受分析证书或合格证书上的结果。「微穹」消毒剂系列，符合最新欧盟GMP附录1要求，为（A／B／C／D）洁净间的消毒提供完美解决方案。

4.39 Fumigation or vapour disinfection (e.g. Vapour-phased Hydrogen Peroxide) of cleanrooms and associated surfaces may be useful for reducing microbial contamination in inaccessible places.

洁净室和相关表面的熏蒸或蒸气消毒（例如，汽化过氧化氢），可能有助于减少无法接触位置的微生物污染。

药知PSA

PSA-无菌保证体系推动者微信群，@叶非：我在B级区用消毒剂进行擦拭，擦拭后检查这个区域内没有菌，那么这个过程，叫做消毒，还是灭菌？按照消毒的定义，是杀不死所有微生物的！但是，使用消毒剂，把所有微生物都杀死了，为什么还是叫消毒？

微信3d70e454

谢 谢楼主分享

菜菜宝贝

谢谢楼主分享，想请问对于如下这句怎么理解呢？现在专家新观点不是取消了之前菌群耐受性的说法，说是消毒剂能杀死，轮换不是为了菌群耐受性，是基于全面覆盖的考虑
“应该定期进行监测，以评估消毒程序的有效性，并发现微生物菌群类型的变化（例如，对当前使用的消毒方案具有耐受性）”

返乡农民工

菜菜宝贝 发表于 2021-4-12 10:21
谢谢楼主分享，想请问对于如下这句怎么理解呢？现在专家新观点不是取消了之前菌群耐受性的说法，说是消毒剂 ...

看你怎么理解了

Maoc

这个不错，好好学习一下

Thomasj96

原文来自哪里？

明and月

感谢楼主分享，正好用到，非常感谢。

昀亦然

谢谢分享，已学习！

ye326423

谢 谢楼主分享

现在还是胖娃

Thomasj96 发表于 2022-1-5 12:58
原文来自哪里？

新版欧盟无菌药品附录

小树冲冲

学习了