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Applitech Biological Technology Co., Ltd. offer service "Welder"

GMP

基本信息

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产品名称

Welder

详情

规格参数

  • 服务范围: 对来自生物反应器、液体储存袋、混合袋、进料袋及取样袋的TPE管道进行无菌断开与焊接
  • 批次规模: 可处理外径1/4英寸至1英寸的管材,具备自动管型识别功能,并预设Saint-Gobain C-Flex 374 TPE参数
  • 监管认证: 符合FDA 21 CFR Part 11要求,具备权限管理和审计追踪功能,并配有无菌性、细菌挑战、抗拉强度及流速测试文件支持

其他信息

补充描述:

This aseptic tube welder performs self-checks before operation with automatic welding and process display, handling 1/4 inch to 1 inch OD tubing across multiple supported tube types with automatic size recognition. It heats to 400°C to sterilize and clear the heat source, ensuring an aseptic weld, comes preloaded with Saint-Gobain C-Flex 374 TPE parameters (adjustable for other TPE tube brands), and uses one-click rotary welding for quick operation. It's used for aseptic disconnection of TPE tubing from bioreactors, storage/mixing/feeding/sampling bags and other single-use components, supported by sterility, bacterial-challenge, tensile-strength, flow-rate, particulate, and pressure test documentation, and is FDA 21 CFR Part 11 compliant with user authority management and audit trail.
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