目的:建立无菌室清洗消毒的标准操作规程,为质控中心无菌室的清洗消毒提供标准,防止污染,确保药品质量控制检验的准确性和真实性。
OBJECTIVE: To establish a standard operating procedure for cleaning and disinfection of sterile room in quality control center, to provide a standard for cleaning and disinfection of sterile room, to prevent pollution, and to ensure the accuracy and
authenticity of drug quality control and inspection.
适用范围:适用于实验室无菌室的清洁消毒。质检中心无菌室工作人员负责本程序的实施,质保部负责监督。
Scope of application: It is suitable for cleaning and disinfection of laboratory aseptic room. The staff of aseptic room of quality inspection center is responsible for the implementation of this procedure, and the quality assurance department is responsible
for supervision.
灭菌操作要点
Main Points of Sterilization Operation
1. 首先对无菌室进行消毒,打开紫外线灯30-60分钟。
1. First, sterilize the sterile room and turn on the ultraviolet lamp for 30-60 minutes.
2. 检查用的有关设备进入无菌室前必须单独消毒。
2. The equipment used for inspection must be disinfected separately before entering the sterile room.
3.操作人员进入无菌室前,必须对双手进行清洁消毒,穿戴无菌工作服、帽子和鞋子。
2. 操作应在火焰区域附近进行。
2. Operation should be carried out near the flame area.
3.接种环、接种针等金属设备使用前、后应进行烧灼处理。烧制时,应先经内火焰烘干残渣,再烧制消毒。
3. The metal equipments such as inoculation rings and needles should be cauterized before and after use. When firing, the residue should be dried by internal flame before firing and disinfecting.
4. 使用吸管时,不要直接用嘴吸或吹吸管,要用耳珠操作。
4. When using the suction tube, do not directly suck or blow the suction tube with the mouth, but operate with ear beads.
5. 观察盘子时,好不要把盖子打开。如果你想接触菌落进行检查,你必须在火焰附近操作。
5. When looking at the dishes, it's better not to open the lid. If you want to contact the colony for inspection, you must operate near the flame.
6、对于可疑致病菌涂片染色,应使用夹片夹玻片,不要直接用手取玻片,以免造成污染,用过的玻片也应放在消毒剂中浸泡消毒,然后清洗。
6. For the staining of suspicious pathogenic bacteria smears, clip slides should be used instead of taking slides directly by hand to avoid contamination. Used slides should also be soaked in disinfectants and disinfected, and then cleaned.
7. 工作结束后,清理工作台上的样品和设备,用消毒剂擦拭工作台上。
7. After work, clean the samples and equipment on the worktable and wipe it with disinfectant.
3. Before entering the sterile room, operators must clean and disinfect their hands and wear sterile overalls, hats and shoes.
4. 进入无菌室后,再次消毒双手,然后进行检查操作。
4. After entering the sterile room, disinfect hands again, and then check the operation.
操作过程记录
Operational process record
动作要轻,不要太快,以免搅动空气增加污染;玻璃器皿应轻拿轻放,以免损坏或污染环境。
Actions should be light, not too fast, so as not to disturb the air and increase pollution; glassware should be handled lightly, so as not to damage or pollute the environment.
昆山昌瑞空调净化技术有限公司,专注从事空气过滤器系列产品(初/中/高效、化学过滤器等)、洁净室净化设备(抛弃式/可更换式/自动卷绕式过滤器、高效送风口、FFU高效过滤器净化机组)的研发、生产、销售和售后。
Changrui Air Conditioning Purification Technology Co., Ltd. focuses on the R&D, production, sales and after-sales of air filter series products (primary/medium/high-efficiency, chemical filters, etc.) and clean room purification equipment (disposable/replaceable/automatic
winding filters, high-efficiency air supply outlets, FFU high-efficiency filter purification units).