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.
在西林瓶无菌分装过程中,一名操作人员穿越RABS XX越过胶塞斗来移除卡住的胶塞。该RABS XX里胶塞斗上方的单向流被中断,带来微生物污染风险。在操作员移除了卡住的胶塞后,灌装线重新启动,但受影响的胶塞并未清出。
There is no sanitisation of hands after each individual garment is touched and put on.
员工在接触和穿上衣服后没有手消
Operators wore outdoor clothes under aseptic gowns in the Grade B zone.
B级区操作人员穿着户外衣服套上无菌服。
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.
更衣程序要求员工进入D级和C级区域时脱掉鞋子。然而所使用的脚套的材质无法防止微生物从员工的脚污染到洁净区地板上。
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区的办公室,员工貌似被允许穿着人字拖、鞋套还有袜子。
During gowning into the manufacturing area the bench was not sanitised prior to sitting on it.
在进入生产区域的更衣期间,长凳在坐上去之前没有消毒。
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级无菌服的时候,发现一个员工好几次碰到了无菌服的外面。
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.
消毒用的抹布看起来不够湿润,只有中间的位置是湿的,而不是整块区域以确保有效的表面覆盖。
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.
一些员工其帽子和口罩的缝隙可见脸部边缘暴露出来的皮肤,导致产品污染的可能,特别是当在层流罩内工作时。
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.
没有任何图示和图解定义分装部件在层流罩或隔离器内位置,以确保单向流得到维持。
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.
员工没有戴眼罩,尽管是在一个开放式层流罩内配料,并且配料工序还可能使用安瓿瓶,这是一个开放式而不是密闭式的操作。
Sanitised rather than sterile googles were permitted to be worn in EU Grade B areas.
在B级佩戴的护目镜没有灭菌,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.
分装针头的和软管的连接过程未能将污染的风险降至最低;导致RABS手套手指屡次与针头暴露的那头相接触。在B级佩戴的护目镜没有灭菌,而只是消毒。