From buffer and media preparation, cell culture operations, purification operations up to final formulation, filtration and transfer, the sterile disconnection is a key element during manufacturing processes.

從緩沖液和培養基的準備、細胞培養操作、純化操作到最終配方、過濾和轉移，無菌斷開是制造過程中的關鍵要素。

It can seal either dry, wet or liquid-filled tubing in non-classified and classified environments while maintaining product sterility once the assemblies are disconnected.

封管機能夠在非潔凈和潔凈環境中密封干燥、濕潤或充滿液體的管材，同時在組件斷開連接后保持產品的無菌性。

2.Operating Principles工作原理

The TPE tubing to be disconnected is inserted into the Biosealer® TC. External clamps have to be added and closed according to the displayed instructions. The TPE tubing is first pressed, then heated up automatically to the defined temperature. When the heating phase is completed, the device cools down the sealing before its release.

將要斷開連接的TPE管材插入Biosealer® TC 中，需要根據顯示的指示添加并關閉外部夾具。TPE管材首先被壓緊，然后自動加熱到設定的溫度。加熱階段完成后，設備在釋放前先冷卻密封部分。

List of Validated TPE Tubing Materials and Sizes Which Can Be Sealed on Biosealer® TC

可在Biosealer® TC 密封的經過驗證的TPE管材材料和尺寸列表

3.Validation Tests驗證測試

3.1 Validation Tests Overview驗證測試概述

The following table summarizes all tests performed on each validated sealing parameters (see 2 for list of validated parameters):

下表總結了對每個已驗證的密封參數（見章節2已驗證參數列表）進行的所有測試。

  3.2 Visual Inspection目視檢查

 3.2.1 Test Purpose測試目的

 Several aspects are considered for visual inspection testing such as   shape, surface or enclosures to secure the highest quality of the sealing.   目視檢查會考慮多個方面，如形狀、表面或封閉情況，以確保密封的最高質 量。

Test Method測試方法

It consists of sealing TPE tubing with the parameter corresponding to a certain tubing material and dimension. The tubing is always sterilized according to the conditions specified in section 3.1. The resulting sealing is then visually inspected by trained operators to assess whether it has

passed or failed the visual inspection test.

它包括使用與特定管材材料和尺寸相對應的參數來密封TPE 管材。管材始終根據第3.1節指定的條件進行滅菌。然后，由訓練有素的操作員對最終形成的密封進行目視檢查，以評估它是否通過了目視檢查測試。

 3.3 Pressure Test壓力測試

The pressure resistance of a sealing is a critical factor to be measured to avoid the sealing reopening, that would lead to a possible leakage and consequent contamination.                                              密封的耐壓性是測量的關鍵因素，以避免密封重新打開，這可能導致泄漏和隨之而來的污染。

3.3.1 Test Purpose測試目的

To submit a sealing to a certain pressure, mimicking the process conditions the sealing might be exposed to, ensuring the robustness of the sealing made with the defined parameters。

為了使密封件承受一定的壓力，模擬密封件可能暴露的工藝條件，以確保按照規定參數制造的密封件的堅固性。

3.3.2 Test Method測試方法

To represent the worst-case scenario, gamma irradiated tubing was only used as well as dry conditions. A sealing is first made with Biosealer® TC and stored for five minutes. Then the sealing is cut into two sealed sections of 15 cm that are connected to pressurized air controlled by a manometer.

為了代表最壞情況，僅使用了伽瑪輻照過的管材以及干燥條件。首先使用 Biosealer® TC進行密封，并存放五分鐘。然后，將密封部分切割成兩個15厘米長的密封段，這些段連接到由壓力表控制的加壓空氣。

The two sealing samples are submitted to a pressure of one bar for 60 seconds. The sealed tubing sections are then visually controlled to have no reopening of the sealing when reaching a critical limit.

將兩個密封樣品置于1bar壓力下60秒。然后目視控制密封油管段，使其在達到臨界極限時不會重新打開密封。