近日，F(xiàn)DA發(fā)布了Empower Clinic Services LLC dba Empower Pharmacy的483缺陷報(bào)告，其中提及潔凈室物品清潔消毒和無菌操作姿勢的缺陷，具體包括：

1.未對無菌灌裝裝機(jī)過程中使用的剪刀進(jìn)行消毒

2.在進(jìn)入生物安全柜之前，未對無菌手套進(jìn)行消毒

3.檢查人員在對灌裝裝機(jī)的觀察過程中，發(fā)現(xiàn)一臺裝在塑料保護(hù)殼內(nèi)的iPad附有布繩，難以清潔和消毒。質(zhì)量總監(jiān)稱，該iPad及保護(hù)殼未被納入環(huán)境監(jiān)測采樣范圍，且在為期4天的無菌操作過程檢查中，確實(shí)沒看到其被消毒。

4.未能對兩名技術(shù)人員使用的、用于記錄裝機(jī)活動的××鋼筆在使用前后進(jìn)行消毒。公司管理層稱，該鋼筆不屬于公司質(zhì)量總監(jiān)所要求的需要消毒的物品。

5.操作人員在ISO 5（A級）區(qū)的操作過程中，將未使用的手以掌心向上的姿勢擺放，F(xiàn)DA認(rèn)為這可能干擾單向氣流，進(jìn)而影響了“首過氣流”。

缺陷翻譯如下：

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

未能對位于 ISO ×× 區(qū)域內(nèi)的設(shè)備進(jìn)行適當(dāng)且定期的清潔、消毒或滅菌。

Specifically,

具體而言，

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.

檢查人員在對灌裝裝機(jī)的觀察過程中發(fā)現(xiàn)，一名技術(shù)人員將剪刀從ISO ××生物安全柜取出后，未使用××對其進(jìn)行消毒，就在ISO ××潔凈室內(nèi)使用，隨后又將剪刀放回了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 ××制劑室××（非無菌配制區(qū)××）準(zhǔn)備L-肉堿（30mL規(guī)格，500mg/ml，批號#221071，有效期至2026年1月2日，數(shù)量××）的過程中，觀察到無菌配制技術(shù)人員在ISO ××潔凈室內(nèi)完成任務(wù)后，返回ISO ××生物安全柜之前，未對無菌手套進(jìn)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.

檢查人員在對灌裝裝機(jī)的觀察過程中，發(fā)現(xiàn)一臺裝在塑料保護(hù)殼內(nèi)的iPad附有布繩，難以清潔和消毒。質(zhì)量總監(jiān)稱，該iPad及保護(hù)殼未被納入環(huán)境監(jiān)測采樣范圍，且在為期4天的無菌操作過程檢查中，確實(shí)沒看到其被消毒。在ISO ××灌裝間的觀察中，也發(fā)現(xiàn)了一臺類似iPad，帶有布繩并裝在塑料保護(hù)殼內(nèi)。

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 ××潔凈室內(nèi)的技術(shù)人員，未能在使用前后對兩名技術(shù)人員使用的、用于記錄裝機(jī)活動的××鋼筆進(jìn)行消毒。公司管理層稱，該鋼筆不屬于公司質(zhì)量總監(jiān)所要求的在ISO ××灌裝潔凈室內(nèi)需要消毒的物品。已與公司管理層就該鋼筆可能成為微生物污染傳播媒介一事進(jìn)行了溝通。

....

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

觀察到人員在進(jìn)行無菌操作時(shí)，ISO ××區(qū)域內(nèi)“首過氣流”被阻擋或干擾。

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.

具體而言，在觀察公司進(jìn)行的手動無菌灌裝與封蓋操作時(shí)，發(fā)現(xiàn)技術(shù)人員在對敞口瓶進(jìn)行灌裝和封蓋期間，將未使用的手以掌心向上的姿勢擺放，這可能干擾單向氣流，進(jìn)而影響了“首過氣流”。類似的手部/掌心擺放方式，也出現(xiàn)在公司2025年4月記錄的氣流流型視頻（E4996-MF-7.mp4、E4996-MF-6.mp4及E4689-MF-7.mp4）中。

此前，F(xiàn)DA在對Baxter Oncology GmbH的483缺陷報(bào)告中，也提及潔凈區(qū)人員姿勢的缺陷：操作人員的手臂處于腰部以下位置，該公司SOP未對將手臂保持在腰部高度這一良好潔凈室行為作出說明：

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.

在對XX灌裝線（RABS）的壓塞系統(tǒng)進(jìn)行裝機(jī)期間，在 B 級潔凈區(qū)觀察到操作人員的手臂處于腰部以下位置。生效日期為 2024 年 8 月 18 日的標(biāo)準(zhǔn)操作程序《無菌生產(chǎn)SOP》未對將手臂保持在腰部高度這一良好潔凈室行為作出說明。

本文由廣州佳譽(yù)醫(yī)療器械有限公司/佛山浩揚(yáng)醫(yī)療器械有限公司聯(lián)合編輯