Reliable gross leak tester for medical device packaging, using bubble emission method. Meets ASTM F2054/F1140 standards with 0-600 kPa range.
The Medical Device Packaging Gross Leak Bubble Tester is designed to ensure the integrity of sealed plastic pouches used in medical applications. Utilizing a positive pressure test principle, it detects gross leaks and ensures compliance with ASTM F2054 and ASTM F1140 standards. The tester operates within a range of 0 to 600 kPa (0 to 87 psi), making it suitable for rigorous quality control processes in the medical device industry, where packaging reliability is critical to prevent contamination and ensure patient safety.
This tester is built for efficiency, with a production capacity of 1500 sets per quarter from our Jinan, Shandong facility. Its robust design ensures consistent performance, even in high-demand environments, making it an ideal choice for manufacturers looking to maintain high standards in packaging integrity. The device’s ability to test for leak burst and gross creep integrity ensures that even the smallest defects are identified, reducing the risk of product recalls and enhancing brand reliability in the competitive medical device market.
This model offers versatility, accommodating various test samples such as sealed plastic pouches. Its straightforward operation and reliable results make it a valuable tool for quality assurance teams. The tester is designed to integrate seamlessly into existing production lines, providing manufacturers with a cost-effective solution to meet stringent regulatory requirements while maintaining operational efficiency and ensuring the safety of medical devices.
No technical features available.
No software features available.
No standards compliance information available.
No customization options available.
No calibration and environment information available.
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