During the aseptic filling of vials, an operator used restricted access barrier system(RABS) (b)(4) to remove a jammed stopper by reaching over exposed sterile stoppers in the stopper bowl. The RABS (b)(4) disrupted theunidirectional airflow over the stopper bowl, creating a risk for microbialcontamination. After the operator removed the jammed stopper, the filling linewas restarted, but the affected stoppers were not cleared.
在西林瓶無菌分裝過程中，一名操作人員穿越RABS XX越過膠塞鬥來移除卡住的膠塞。該RABS XX裡膠塞鬥上方的單向流被中斷，帶來微生物汙染風險。在操作員移除了卡住的膠塞後，灌裝線重新啟動，但受影響的膠塞並未清出。
There is no sanitisation of hands after each individual garment is touched and put on.
員工在接觸和穿上衣服後沒有手消
Operators wore outdoor clothes under aseptic gowns in the Grade B zone.
B級區操作人員穿著戶外衣服套上無菌服。
Gowning procedures required operators to remove their shoes when entering grade D and C areas. The nature of the foot coverings used would not prevent microbial contamination passing from the operator’s feet onto the clean room floors.
更衣程序要求員工進入D級和C級區域時脫掉鞋子。然而所使用的腳套的材質無法防止微生物從員工的腳汙染到潔淨區地板上。
In the main office of Block B manufacturing operators appeared to be allowed to wear flip flops, shoes with over-shoes or socks.
在B區的辦公室，員工貌似被允許穿著人字拖、鞋套還有襪子。
During gowning into the manufacturing area the bench was not sanitised prior to sitting on it.
在進入生產區域的更衣期間，長凳在坐上去之前沒有消毒。
While donning sterile gloves prior to entering a grade B area an operator was observed touching the outside of sterile gloves on several occasions.
在穿B級無菌服的時候，發現一個員工好幾次碰到了無菌服的外面。
The wipes used for sanitisation did not appear to be wetted sufficiently as only the area in the centre appeared to be wet rather than the whole area to ensure effective surface coverage.
消毒用的抹布看起來不夠溼潤，只有中間的位置是溼的，而不是整塊區域以確保有效的表面覆蓋。
A gap between the hood and mask was seen for some operators resulting in exposed skin at the side of the face with the potential for product contamination especially when working in a LAF cabinet.
一些員工其帽子和口罩的縫隙可見臉部邊緣暴露出來的皮膚，導致產品汙染的可能，特別是當在層流罩內工作時。
There are currently no drawings or diagrams which define the positioning of components in the laminar air flow (LAF) cabinet or isolators to ensure that unidirectional airflow is maintained.
沒有任何圖示和圖解定義分裝部件在層流罩或隔離器內位置，以確保單向流得到維持。
Operators do not wear goggles even though compounding is conducted in an open LAF cabinet and ampoules may be used in the compounding process which is an open rather than a closed manipulation.
員工沒有戴眼罩，儘管是在一個開放式層流罩內配料，並且配料工序還可能使用安瓿瓶，這是一個開放式而不是密閉式的操作。
Sanitised rather than sterile googles were permitted to be worn in EU Grade B areas.
在B級佩戴的護目鏡沒有滅菌，而只是消毒。
The sequence of installing the filling needles and connecting tubing did not minimise contamination risks; the sequence used resulted in contact between fingers of the restricted access barrier system (RABS) glove and the exposed tops of needles on several occasions.
分裝針頭的和軟管的連接過程未能將汙染的風險降至最低；導致RABS手套手指屢次與針頭暴露的那頭相接觸。在B級佩戴的護目鏡沒有滅菌，而只是消毒。