英启无菌接管机焊管机焊接机

概述 Description
Tube-Welder I是一种全自动装置，用于无菌焊接热塑管。
The Tube-Welder I is a fully automated device for connecting thermoplastic tubing in a sterile welding operation.
该全自动装置可无菌连接外径1/4至3/4英寸的热塑管。
The fully automated device allows sterile connection of tubing with outer diameter from 1/4" to 3/4".
应用 Applications
Tube-Welder I 用于连接生物 制药工艺中使用的一次性袋 上的热塑管， 例如C-flex® 、 Advantaflex®。可在 非无菌环境中连接单个袋子 或袋子组件，并保持产品的无 菌性。
The  Tube-Welder  I  is  used to connect thermoplastic tubing such as C-Flex®, Advantaflex®, on disposable bag assemblies used in biopharmaceutical manufacturing processes. Individual bags or bag assemblies can be connected in a non sterile environment by maintaining sterility of the product.
工作原理 Operating Principle
将 管 夹 、 刀 片 和 管 子 装 入 Tube-Welder I，焊接过程完全自动 化。刀片经加热去热原（≥400℃） 后冷却至焊接温度。在整个焊接过 程中通过红外温度传感器监控刀片 温度。当刀片温度达到焊接温度时， 刀片切割热塑管，热塑管被连接形成所需的流体管路。
After the holders, blade and tubes are placed on the right position of the Tube-Welder I，the following welding process is fully automated. The blade is heated up（≥400℃）
for depyrogenation, then cooled down to the welding temperature. An infrared sensor monitors and controls the blade temperature during the entire welding process. When the blade reaches the welding temperature, the blade cuts the tubes and the new fluid path is welded together.
设备特点 Features of Tube-Welder
操作简单，在上盖开启状态下也能进行复位操作，一 键复位，一键焊接 。 预设程序可用 于 C-Flex®, AdvantaPure AdvantaFlex®热塑管的连接。热焊接可保证焊缝具有很高的强度。在 非无菌环境，亦可实现无菌连接。设计紧凑，移动方便。验证简单，可提供验证文件。一台机器可焊接多种不同的管径热塑管。
Easy to use. Reset operation can be executed even the upper cover is open. With one key reset and one key welding. Preinstalled settings for C-Flex®, AdvantaPure AdvantaFlex®, Pharmed® and Sanipure® tubing. True thermal weld provides exceptional strength. Aseptic connection without a laminar flow hood. Compact design, portable. Easy to validate, with validation equipment. One machine  can handle tubes with different diameters.
设计遵循法规和国家标准Regulatory and Statutory Compliance
中国GMP（2010年修订版）Good Manufacturing Practice for Medicines (Revision 2010)
GB19489-2008 实验室生物安全通用要求
GB19489-2008 Laboratories-General Requirements for biosafety
GB 19517-2009 电气设备安全技术规范标准
GB 19517-2009 National Safety Technical Code for Electric Equipment
GB-52261-2008 机械安全机械电气设备第一部分：通用技术条件
Safety of Machinery - Electrical Equipment of Machines- Part 1: General Requirements

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