無菌操作技術(shù)和培養(yǎng)基模擬灌裝相關(guān)的注意點(diǎn)
發(fā)布時(shí)間：
2022-12-27
作者：
無菌操作技術(shù)和培養(yǎng)基模擬灌裝相關(guān)的注意點(diǎn)
以下是關(guān)于無菌操作技術(shù)和培養(yǎng)基模擬灌裝相關(guān)的注意點(diǎn)，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(shè)備(例如分裝針頭)的袋子使用撕裂的方式打開，這會(huì)給設(shè)備/生產(chǎn)線及產(chǎn)品帶來纖維污染的風(fēng)險(xiǎn)。
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.
裝有膠塞軌道的最里面的袋子在放入分裝線之前被拆破，這會(huì)給膠塞和產(chǎn)品帶來纖維污染的風(fēng)險(xiǎn)。
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(jù)證明滅菌后的無菌污染的數(shù)量已經(jīng)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后沒有手消
Operators wore outdoor clothes under aseptic gowns in the Grade B zone.
B級(jí)區(qū)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(jìn)入D級(jí)和C級(jí)區(qū)域時(shí)脫掉鞋子。然而所使用的腳套的材質(zhì)無法防止微生物從員工的腳污染到潔凈區(qū)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(qū)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(jìn)入生產(chǎn)區(qū)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(jí)無菌服的時(shí)候，發(fā)現(xiàn)一個(gè)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(jī)在生產(chǎn)前只有被員工接觸到的表面或與產(chǎn)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.
用于懸掛瓶子和袋子的鉤子沒有得到適當(dāng)?shù)那鍧崳驗(yàn)樗麄儽荒迷诓僮魅藛T的手里，一組一組的消毒，而不是一個(gè)一個(gè)，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(qū)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(dǎo)致產(chǎn)品污染的可能，特別是當(dāng)在層流罩內(nèi)工作時(shí)。
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(nèi)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，盡管是在一個(gè)開放式層流罩內(nèi)配料，并且配料工序還可能使用安瓿瓶，這是一個(gè)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(jí)佩戴的護(hù)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(fēng)險(xiǎn)降至最低；導(dǎo)致RABS手套手指屢次與針頭暴露的那頭相接觸。在B級(jí)佩戴的護(hù)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(diào)查未包括事件的列表，并且也沒有包括針對(duì)每個(gè)事件采取的糾正措施的全部細(xì)節(jié)，例如操作員的評(píng)估、操作員的再培訓(xùn)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，并且以致于污染的微生物沒能被鑒別到可以幫助調(diào)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(yǎng)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(jìn)行標(biāo)記，以致于受污染的樣品何時(shí)發(fā)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(yǎng)基模擬灌裝和工藝驗(yàn)證研究沒有獲取所用的無菌生產(chǎn)工藝的全部細(xì)節(jié)，因此無法緊密模擬生產(chǎn)工藝，并不能代表最差條件。
日水培養(yǎng)基