無菌操作技術和培養基模擬灌裝相關的缺陷

以下為2016年間收集的關於無菌操作技術和培養基模擬灌裝相關的缺陷，供大家參考：

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.

裝有分裝設備(例如分裝針頭)的袋子使用撕裂的方式打開，這會給設備/生產線及產品帶來纖維污染的風險。

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.

裝有膠塞軌道的最裡面的袋子在放入分裝線之前被拆破，這會給膠塞和產品帶來纖維污染的風險。

There was insufficient evidence documented to demonstrate that the number of aseptic connections after sterilisation had been minimised.

沒有充分的文件證據證明滅菌後的無菌污染的數量已經被減至最少。

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污染到潔凈區地板上。

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。

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.

混合機在生產前只有被員工接觸到的表面或與產品接觸的表面才被消毒，而沒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.

用於懸掛瓶子和袋子的鉤子沒有得到適當的清潔，因為他們被拿在操作人員的手裡，一組一組的消毒，而不是一個一個，以確保消毒到所有表面。

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.

消毒用的抹布看起來不夠濕潤，只有中間的位置是濕的，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，導致產品污染的可能，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污染的風險降至最低；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。

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.

模擬分裝失敗的調查未包括事件的列表，並且也沒有包括針對每個事件採取的糾正措施的全部細節，例如操作員的評估、操作員的再培訓等。

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.

沒有保留受污染的樣品，並且以致於污染的微生物沒能被鑒別到可以幫助調查的特定水平。

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.

培養基模擬灌裝的批量是60袋，然而它們沒有按照分裝的順序進行標記，以致於受污染的樣品何時發生無法確定。

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.

培養基模擬灌裝和工藝驗證研究沒有獲取所用的無菌生產工藝的全部細節，因此無法緊密模擬生產工藝，並不能代表最差條件。

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