近日，FDA发布了Empower Clinic Services LLC dba Empower Pharmacy的483缺陷报告，其中提及洁净室物品清洁消毒和无菌操作姿势的缺陷，具体包括：

1.未对无菌灌装装机过程中使用的剪刀进行消毒

2.在进入生物安全柜之前，未对无菌手套进行消毒

3.检查人员在对灌装装机的观察过程中，发现一台装在塑料保护壳内的iPad附有布绳，难以清洁和消毒。质量总监称，该iPad及保护壳未被纳入环境监测采样范围，且在为期4天的无菌操作过程检查中，确实没看到其被消毒。

4.未能对两名技术人员使用的、用于记录装机活动的××钢笔在使用前后进行消毒。公司管理层称，该钢笔不属于公司质量总监所要求的需要消毒的物品。

5.操作人员在ISO 5（A级）区的操作过程中，将未使用的手以掌心向上的姿势摆放，FDA认为这可能干扰单向气流，进而影响了“首过气流”。

缺陷翻译如下：

Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO ×× area.

未能对位于 ISO ×× 区域内的设备进行适当且定期的清洁、消毒或灭菌。

Specifically,

具体而言，

A. During observation of the filling setup for the finished sterile drug, L-Carnitine (30mL) 500 mg/ml, Lot # 221071, BUD 1/2/2026, Qty. ×× units, in ISO ×× Formulation Room ×× (Non-sterile Compounding Suite ××), a technician failed to disinfect ×× scissors with ×× after removing from ISO ×× BSC, using them within the ISO ×× Cleanroom, then returning them to the ISO ×× BSC.

检查人员在对灌装装机的观察过程中发现，一名技术人员将剪刀从ISO ××生物安全柜取出后，未使用××对其进行消毒，就在ISO ××洁净室内使用，随后又将剪刀放回了ISO ××生物安全柜。

B. Sterile compounding technician was observed failing to disinfect sterile gloves after performing task within ISO ×× Cleanroom prior to returning to the ISO ×× BSC, while setting up L-Carnitine (30mL), 500 mg/ml, Lot # 221071, BUD 1/2/2026, Qty. ×× in ISO ×× Formulation Room ×× (Non-sterile Compounding Suite ××).

在ISO ××制剂室××（非无菌配制区××）准备L-肉碱（30mL规格，500mg/ml，批号#221071，有效期至2026年1月2日，数量××）的过程中，观察到无菌配制技术人员在ISO ××洁净室内完成任务后，返回ISO ××生物安全柜之前，未对无菌手套进行消毒。

C. During observation of the filling setup for the finished sterile drug, L-Carnitine (30mL), Qty. ×× units, Lot # 221071 in ISO ×× Formulation Room ×× (Non-sterile Compounding Suite ××), an iPad contained within a plastic protective case was found with a cloth string attached, which is hard to clean and disinfect. Quality Director reported iPad and case is not included as part of EM sampling and was observed not being disinfected during any of the 4-day sterile aseptic processing observations. A similar iPad contained within a plastic protective case was found with a cloth string attached is also within the ISO ×× Filling Cleanroom.

检查人员在对灌装装机的观察过程中，发现一台装在塑料保护壳内的iPad附有布绳，难以清洁和消毒。质量总监称，该iPad及保护壳未被纳入环境监测采样范围，且在为期4天的无菌操作过程检查中，确实没看到其被消毒。在ISO ××灌装间的观察中，也发现了一台类似iPad，带有布绳并装在塑料保护壳内。

D. Technicians within ISO ×× Cleanroom failed to disinfect ×× pen used by two different technicians for documenting setup activities prior to and after use. Firm management reported, the pen is not part of the items required to be disinfected within the ISO ×× Filling Cleanroom per the firm's quality director. Discussions were held with the firm's management regarding the pen being a microbial contamination transfer point.

ISO ××洁净室内的技术人员，未能在使用前后对两名技术人员使用的、用于记录装机活动的××钢笔进行消毒。公司管理层称，该钢笔不属于公司质量总监所要求的在ISO ××灌装洁净室内需要消毒的物品。已与公司管理层就该钢笔可能成为微生物污染传播媒介一事进行了沟通。

....

Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO ×× area is blocked or disrupted.

观察到人员在进行无菌操作时，ISO ××区域内“首过气流”被阻挡或干扰。

Specifically, during observation of the firm's manual aseptic filling and stoppering within ISO ×× Formulation Room ×× (Non-hazardous drug formulation and filling) and ISO ×× Formulation Room ×× (Hazardous drug formulation and filling) within ×× air flow ISO ×× BSCs, technicians were observed disrupting "first air" during filling and capping open vials by holding the hand that is not in use with an open palm up potentially disrupting unidirectional air flow. Similar hand/palm orientation technique was observed in the firm's April 2025 recorded smoke studies, E4996-MF-7.mp4, E4996-MF-6.mp4, and E4689-MF-7.mp4.

具体而言，在观察公司进行的手动无菌灌装与封盖操作时，发现技术人员在对敞口瓶进行灌装和封盖期间，将未使用的手以掌心向上的姿势摆放，这可能干扰单向气流，进而影响了“首过气流”。类似的手部/掌心摆放方式，也出现在公司2025年4月记录的气流流型视频（E4996-MF-7.mp4、E4996-MF-6.mp4及E4689-MF-7.mp4）中。

此前，FDA在对Baxter Oncology GmbH的483缺陷报告中，也提及洁净区人员姿势的缺陷：操作人员的手臂处于腰部以下位置，该公司SOP未对将手臂保持在腰部高度这一良好洁净室行为作出说明：

During assembly of the stopping system to the （b）(4) filling line (RABS) on （b）(4) operator arms were observed below their waist level in Grade B space. Standard Operating Procedure "Verfahrensanweisung Aseptische Herstellung in der Pharmaproduktion", Effective 18 August 2024, fails to describe the good clean room behavior, having arms trained at waist level.

在对XX灌装线（RABS）的压塞系统进行装机期间，在 B 级洁净区观察到操作人员的手臂处于腰部以下位置。生效日期为 2024 年 8 月 18 日的标准操作程序《无菌生产SOP》未对将手臂保持在腰部高度这一良好洁净室行为作出说明。

本文由广州佳誉医疗器械有限公司/佛山浩扬医疗器械有限公司联合编辑