Everything above Sealing Test Card for the Sealing Devices in Medical packaging sector

Sealing Test Card Overview:

AMD Sealing Test Card is designed to verify the performance and quality of sealing devices through a comprehensive process of forming, sealing, and assembly. This process follows the guidelines set forth in ISO 11607-2:2006 Part 2, ensuring the sealing equipment meets required standards for identification and qualification. The test is conducted by running a program that checks for potential defects and assesses the extent of sealing performance.

Key performance parameters are monitored during the sealing process, allowing for visual confirmation of sealing quality, including the identification of defects. The sealing machine is equipped with a program to print identification records, enabling troubleshooting and adjustments to sealing parameters to maintain optimal sealing performance.

The system is also capable of archiving data for future batches, allowing for the verification of sealing effects on products, ensuring consistent quality and compliance with ISO standards.

Sealing Quality Requirements (ISO 11607-2):

To meet ISO 11607-2 quality standards, sealing lines must satisfy the following criteria:

● Continuous seal width and complete sealing.

● No passage or openings in the seal.

● No perforations or tears.

● No delamination or separation of the sealed materials.

● Installation Qualification (IQ) ensures the sealing machine is installed correctly and performs as expected.

● The Sealing Performance Qualification (OQ) verifies the operational parameters of the machine, including sealing pressure, speed, and temperature, to ensure they align with material requirements.

● Sealing parameters should be adjusted to maintain the desired sealing quality, ensuring no deviations in pressure, temperature, or sealing integrity.

Sealing Process Monitoring and Identification:

During the sealing process, the following factors are closely monitored:

● Sealing pressure and its effect on the formation of passage or opening lines.

● The correct temperature range for effective sealing.

● Continuous sealing without leaks or interruptions.

● Adjustments to sealing parameters based on test results to maintain consistent quality.

These rigorous tests and monitoring ensure that your sealing operations meet the highest quality standards and produce reliable, defect-free products.

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