|
以下是关于无菌操作技术和培养基模拟灌装相关的注意点，供大家参考:
Bags containing filling equipment (for example filling needles) were opened by tearing the bag which presented a risk of introducing fibres to the equipment/line and subsequently the product.
装有分装设备(例如分装针头)的袋子使用撕裂的方式打开，这会给设备/生产线及产品带来纤维污染的风险。
The innermost bag containing the stopper track was damaged prior to loading into the filling line which presented a risk of fibres being transferred to stoppers and subsequently the product.
装有胶塞轨道的最里面的袋子在放入分装线之前被拆破，这会给胶塞和产品带来纤维污染的风险。
There was insufficient evidence documented to demonstrate that the number of aseptic connections after sterilisation had been minimised.
没有充分的文件证据证明灭菌后的无菌污染的数量已经被减至最少。
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。
Only the surfaces which are touched by the operator or are in contact with components on the compounder are sanitised before manufacture, rather than all surfaces as expected.
混合机在生产前只有被员工接触到的表面或与产品接触的表面才被消毒，而没有按要求消毒所有表面。
The hooks used for hanging bottles and bags were not cleaned appropriately as they were held together with the operator’s hand and sanitised as a group rather than individually to ensure that all surfaces are sanitised.
用于悬挂瓶子和袋子的钩子没有得到适当的清洁，因为他们被拿在操作人员的手里，一组一组的消毒，而不是一个一个，以确保消毒到所有表面。
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。
The investigation into the media fill failure did not include a full chronology of events and did not include full details of all the corrective actions taken at each event. e.g. operator assessments, re-training of operators.
模拟分装失败的调查未包括事件的列表，并且也没有包括针对每个事件采取的纠正措施的全部细节，例如操作员的评估、操作员的再培训等。
A sample of the contaminated bag was not kept and therefore the contaminating organism was not able to be identified to species level which would have aided any investigation.
没有保留受污染的样品，并且以致于污染的微生物没能被鉴别到可以帮助调查的特定水平。
The media fill batch size was 60 bags, however these were not labelled in the order of filling and therefore the position of the contaminated container could not be determined.
培养基模拟灌装的批量是60袋，然而它们没有按照分装的顺序进行标记，以致于受污染的样品何时发生无法确定。
The media fill and process validation studies did not capture the full complexity of the aseptic manufacturing processes used and therefore did not closely imitate the production process and were not representative of worst case.
培养基模拟灌装和工艺验证研究没有获取所用的无菌生产工艺的全部细节，因此无法紧密模拟生产工艺，并不能代表最差条件。
|
