China Zhejiang Taizhou Ambe Trading Co., Ltd. is a manufacturer specializing in the production of medical equipment automation equipment.
The plasma/blood port stopper clamp assembly machine is a key equipment dedicated to the production of medical consumables such as blood transfusion equipment and infusion lines. Its core function is to efficiently and accurately complete the automated assembly and functional testing of the stopper clamp assembly to ensure the safety and reliability of medical devices in clinical use. The following are its specific functions and values:
1. Core function: high-precision assembly of the stopper clamp assembly
Precise assembly: automatically complete the alignment and pressing of the clamp body, spring, slider and other micro-components of the stopper clamp to ensure uniform clamping force (usually controlled within the range of 0.5~1.2N) to avoid leakage or blockage during blood delivery.
Multi-material compatibility: adapt to pipe sockets of different materials such as silicone, PVC, polypropylene, etc. to avoid material deformation or damage caused by manual assembly.
2. Safety control: strict leakage prevention and pollution prevention
Sealing test: integrated air pressure/negative pressure detection module, simulates clinical pressure conditions, and automatically screens defective products with poor clamping (such as leakage rate must be ≤0.1%).
Aseptic environment guarantee: The equipment is equipped with a clean cabin or partial laminar flow hood, which complies with GMP/ISO 13485 standards to prevent microbial contamination during the assembly process.
3. Intelligent quality control
Real-time process monitoring: Optical sensors are used to detect key parameters such as the opening and closing angle of the clamp (such as 60°±2°) and the spring reset force, and out-of-tolerance automatic alarms and removals are issued.
Data traceability: The assembly parameters and test results of each batch of products are recorded, and the connection with the MES system is supported to meet the regulatory requirements of UDI (unique device identification) for medical devices.
4. Improve production efficiency and consistency
High-speed automation: The production capacity of a single machine can reach 300~600 pieces/minute, which is 8~10 times higher than that of manual assembly, and the yield rate is stable at more than 99.5%.
Flexible production: Through the rapid changeover design, it is compatible with different specifications of stop clamps (such as blood bags, infusion sets, dialysis lines, etc.).
Industry Value
This device directly solves the risk of failure of the stop function of blood transfusion/infusion equipment (such as blood backflow or contamination caused by loose clamping). Through automation and digital technology, it provides zero-defect manufacturing guarantee for high-risk medical devices such as plasma bags and blood transfusion devices, especially in line with the extreme safety requirements of blood stations, biopharmaceuticals, emergency medical care and other fields.
Innovation extension: Some high-end models can also integrate laser marking or RFID implantation functions to further enhance product traceability.