Peel test for sealing devices

The peel test is regulated in the standard DIN EN 868-5 "Packaging for medical devices to be sterilized in the final packaging". Part 5 of this standard describes the requirements and test methods for sealable transparent bags and tubes made of porous materials and plastic laminates. Annex E of DIN EN 868-5 describes special methods for determining the peel properties of paper-plastic composite films. In addition, the peel test can be integrated into the validation of packaging processes according to DIN EN ISO 11607-2 in accordance with the guidelines of the German Society for Sterile Supply (DGSV).

In medical and dental practices and other medical facilities where medical devices are sealed, processed and stored in clear sterilization packaging, quality assurance of the packaging process plays a crucial role. The peel test is a manual test method for assessing the strength and integrity of a sealed seam by opening the packaging in the peel direction. Various criteria such as the force required and the chamfering of the sealed seam are evaluated. Alongside the seal check, the ink test and the seal seam strength test, the peel test is a common method for assessing the seal seam quality of a sealing device.

Performing the peel test makes it possible to detect and rectify faulty seals in good time. This is because only correctly sealed packaging ensures the sterility of the medical devices and instruments it contains. The German Society for Sterile Supply (DGSV) recommends the peel test as a routine measure to ensure that the seals meet the normative requirements.

1. Switch on the sealing device and wait until the set temperature is reached.

2. Insert a tube section of the transparent packaging to be tested into the sealing device and seal it on the peel side.

3. Subject the sealed tube section to a sterilization cycle in the autoclave.

4. After steam sterilization, visually check that the sealing seam is intact and extends over the entire width and length.

5. Pull the sealing seams apart slowly and carefully along the peel direction by hand. There should be no fraying of the paper more than 10 mm from the seal seams.

6. The results of the peel test should be documented together with the recorded process parameters of the sealing device.

It should be noted that in a rotary sealer the seal seam to be tested is determined by the circumference of the roll (approx. 20 cm), whereas in a bar sealer the sealing area of the heating bar defines the seal seam to be tested.

The peel test is thus an effective way of checking the quality and integrity of the sealed seam of medical devices in medical and dental practices. By performing the peel test on a regular basis, potential defects can be identified and corrected at an early stage to ensure that the sterility of the packaging is maintained. This contributes to patient safety and compliance with quality standards. Regular documentation of peel test results is crucial to demonstrate compliance with quality standards and to initiate improvement measures if necessary.

The peel test should always be performed as part of the validation and performance evaluation of packaging processes. In addition, medical and dental practices that reprocess medical devices should individually determine the frequency with which the peel test should be performed. It is recommended that the peel test be performed and documented at the beginning of each working day on which instruments are reprocessed.

In medical and dental practices, the sterilisation of instruments is crucial to ensure a safe and germ-free treatment environment. Sealing devices play an important role in this process as they seal instruments airtight in sterilisable packaging. The peel test is an essential method for checking the quality and safety of these seals.

The peel test measures the force required to open the seal of a sterilised pack. A correct peel test guarantees that the seal is strong enough to maintain the sterility of the contents until use, but not so strong that opening it would jeopardise sterility or put unnecessary strain on medical staff. A seam that is too weak could lead to contamination, while a seam that is too strong could damage the packaging when opened and also pose a risk of contamination or injury.

The results of the peel test are a direct indicator of the quality of the sealed seam. Documentation of the test results is essential for quality control and should be part of a comprehensive quality management system. Regular inspections of the sealing equipment and adjustments to the sealing parameters are required to ensure consistent results.