Medical Device Packaging Gross Leak Bubble Tester in ChinaGross Leak Tester

Product Description

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.

Product Parameter

The test range of 0 to 600 kPa (0 to 87 psi) allows for comprehensive leak detection, ensuring that packaging meets the highest standards of integrity. This wide range is ideal for testing sealed plastic pouches used in medical devices, where even minor leaks can have serious consequences. Compliance with ASTM F2054 and F1140 standards ensures that the tester meets global regulatory requirements, providing manufacturers with confidence in their quality control processes.

The positive pressure test principle enhances the tester’s ability to detect gross leaks accurately. By applying controlled pressure, the device identifies defects that could compromise the sterility of medical devices, such as syringes or surgical kits. This method is highly effective for ensuring that packaging maintains its barrier properties, protecting contents from environmental contaminants and ensuring patient safety during use.

With a production capacity of 1500 sets per quarter, the leak bubble tester is designed to meet the demands of large-scale manufacturers. This capacity ensures timely delivery for bulk orders, allowing businesses to scale their operations without delays. The tester’s origin in Jinan, Shandong, reflects its high manufacturing standards, providing a reliable solution for medical device companies looking to maintain consistent quality across their product lines.

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