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Tube Sealer: The "Sterile Sealing Guardian" for Infusion Set Tubing
Views: 412 Author: Site Editor Publish Time: 2025-11-18 Origin: Site
Tube Sealer: The "Sterile Sealing Guardian" for Infusion Set Tubing
In the field of disposable medical device production, the Tube Sealer is a core equipment to ensure the sealing performance of infusion set tubing connections. It uses "medical-grade temperature control + pressure closed-loop control" technology to accurately melt and bond the PVC or TPU tubing of the infusion set with components such as drip chambers and connectors, forming a gap-free and stretch-resistant sealing structure that can withstand 0.6MPa water pressure without leakage. It effectively isolates external pollution and avoids the risk of medicinal solution leakage or bacterial invasion during infusion. Widely used in the production of gravity infusion sets and precision filtration infusion sets, a single equipment can complete 1500-2000 sets of tubing sealing per hour, with a sealing qualification rate stable above 99.95%, complying with medical device GMP production standards.
Operating the Tube Sealer must follow the principle of "material matching + sterile operation". When processing PVC tubing, the heat-sealing temperature is set to 170℃-190℃, the pressure is controlled at 0.45MPa-0.55MPa, and the heat-sealing time is 1.2-1.8 seconds to avoid tubing embrittlement caused by excessive temperature; when processing flexible TPU tubing, the temperature is reduced to 150℃-170℃, the pressure is adjusted to 0.35MPa-0.45MPa, and an arc-shaped pressure head is used to ensure uniform force on the sealing surface. Before operation, the mold must be sterilized with ultraviolet light for 30 minutes, and the tubing must be positioned by a sterile clamping device during loading to prevent contamination caused by manual contact. A leak test with sterile water must be performed before each batch production, and mass production can only be carried out after passing the test.
Daily maintenance should focus on "mold precision" and "sterile cleaning". After each use, wipe the heat-sealing mold with sterile gauze dipped in medical alcohol to remove residual molten plastic, then purge the mold gaps with sterile nitrogen; disassemble the mold every week to check the contact between the heating element and the temperature measurement point, and re-calibrate if there is poor contact to ensure the temperature error is ≤±1℃; calibrate the pressure sensor every month to ensure the pressure control accuracy reaches 0.01MPa; replace the medical-grade silicone pad of the mold every quarter to avoid uneven sealing pressure caused by silicone aging. The equipment must undergo regular microbial testing to ensure the sterility of the chamber meets ISO 14644-1 Class 7 standard.
Compared with the traditional glue bonding process, the Tube Sealer has the advantages of no chemical residues, high sealing strength (tensile strength ≥15N), and 40% higher production efficiency. Moreover, the sealing process can record temperature and pressure data in real time to realize full-process traceability. With the improvement of sterile safety requirements in the medical device industry, Tube Sealers with intelligent touch screen control, automatic fault alarm, and quick change of multi-specification molds have become core equipment for infusion set manufacturers to ensure product quality and obtain FDA and CE certifications.
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