歐盟GMP附錄1-對(duì)消毒劑的要求解讀

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.

潔凈室的消毒尤為重要。應(yīng)按照書(shū)面程序徹底清潔和消毒它們。為了使消毒有效，應(yīng)事先進(jìn)行清潔以去除表面污染。應(yīng)該使用一種以上的消毒劑，以確保它們具有不同的作用方式，其組合使用應(yīng)對(duì)所有細(xì)菌和真菌有效。消毒應(yīng)包括定期使用殺孢子劑。應(yīng)該定期進(jìn)行監(jiān)測(cè)，以評(píng)估消毒程序的有效性，并發(fā)現(xiàn)微生物菌群類(lèi)型的變化（例如，對(duì)當(dāng)前使用的消毒方案具有耐受性）。清潔程序應(yīng)有效去除消毒劑殘留。

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.

消毒工藝應(yīng)經(jīng)過(guò)驗(yàn)證。驗(yàn)證研究應(yīng)證明消毒劑以指定使用方式下的適用性和有效性，支持所制備溶液的使用效期。

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級(jí)區(qū)和B級(jí)區(qū)中使用的消毒劑和清潔劑在使用前應(yīng)無(wú)菌（C級(jí)和D級(jí)使用的消毒劑也可能要求無(wú)菌）。如果消毒劑和清潔劑是由無(wú)菌產(chǎn)品生產(chǎn)商配制的，則應(yīng)對(duì)其進(jìn)行微生物污染監(jiān)測(cè)。稀釋液應(yīng)保存在已清潔的容器中，并且只能在效期內(nèi)貯存。如果消毒劑和清潔劑是“即開(kāi)即用”的，則在成功完成相應(yīng)供應(yīng)商確認(rèn)的前提下，可以接受分析證書(shū)或合格證書(shū)上的結(jié)果?！?/span>微穹」消毒劑系列，符合最新歐盟GMP附錄1要求，為（A／B／C／D）潔凈間的消毒提供完美解決方案。

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.

潔凈室和相關(guān)表面的熏蒸或蒸氣消毒（例如，汽化過(guò)氧化氫），可能有助于減少無(wú)法接觸位置的微生物污染。