Ensuring the integrity of packaging materials used for terminally sterilized medical devices is of utmost importance in the healthcare industry. Proper packaging safeguards the sterility of medical equipment and devices, preventing contamination and ensuring patient safety. Two essential standards in this domain are the French Pharmacopée (NF EN 868-5) and ASTM F88-15. This article focuses on ASTM F88-15, which defines the testing protocols for evaluating the seal strength of flexible barrier materials used in medical packaging.
Testing Methodology
ASTM F88-15 specifies the procedures for determining the sealstrength of flexible barrier materials used in packaging. This testmethod is crucial in assessing the sealing quality of packagingmaterials and identifying their suitability for medical applications. Thestandard prescribes the removal of several test strips, each having awidth of 15 mm, 25 mm, or 25,4mm from the packaging to be analyzed.
To ensure accurate andrepeatable results, a tensile testis performed using a UniversalTesting machine. The samplesare positioned as detailedin the standard, and a T-Peelmeasurement test is conductedon the cut-out strips untilbreakage occurs.
This test method aims to assess the quality of the sealing bymeasuring the maximum force applied and calculating the averagehold during the test duration.
ASTM F88-15 specifies that 10% of the test’s initial and final portionsare excluded from the calculations.It is recommended to conduct the test at speeds ranging from 200to 300 mm/min. The choice
of the testing speed may depend on thespecific requirements of the packaging material and the equipmentbeing tested.
Sample Holding Methods
The method for holding the samples can vary depending onthe nature of the products to be tested. The choice of sampleholding method is critical to ensure that the test accuratelyreflects the real-world conditions that the packaging materialswill face in medical applications.
Testing
The key parameters to be measured during the testing are PeakLoad, Max Load (Ultimate Tensile Strength), and Average PeelForce. These parameters provide critical insights into the sealstrength of the flexible barrier materials and their suitability formedical packaging.
To perform these tests accurately, specialized equipment isrequired. The Nexygen Plus system is highlighted as the softwarethat can automatically respect the rule of 10-90% for anyspecimen, which is essential for precise calculations of AveragePeel Force.
The Nexygen Plus system works in conjunction with the LS1 machine, which offers various features, including:
Max Travel: 500 mm (800 mm on the LS5)
Resolution: 0.01 mm
Tensile-compression testing capabilities
Strength, deformation, and height control (with Nexygen Plus)
Dynamic compensation by force sensor
The YLC load cell is another crucial component, with features that include:
Capacity ranging from 5N to 1000N
Accuracy: 0.5% of value read
In addition to the equipment mentioned above, the Nexygen Plus Software plays a pivotal role in test data acquisition, analysis, and reporting.
It ensures that the results obtained are accurate, and it is instrumental in calculating the Average Peel Force.
Nexygen Plus stands out as a preferred system for medical peel testing, particularly due to its seamless execution of the 3 Seal Batch Test as prescribed by ASTM F88-15. This test is simplified with Nexygen Plus, offering comprehensive data, including the average seal force, to streamline the testing process.
Results and Equipment
ASTM F88-15 defines the standard test method for evaluating the seal strength of flexible barrier materials used in medical packaging.
This testing protocol is critical for maintaining the sterility of medical devices and ensuring patient safety. By conducting tensile tests using Evaluating the Seal Strength of Flexible Barrier Materials in Medical Packaging Evaluating the Seal Strength of Flexible Barrier Materials in Medical Packaging a Universal Testing machine, healthcare professionals can accurately assess the quality of sealing in medical packaging materials.
The choice of equipment, such as the LS1 machine and the Nexygen Plus system, is essential for achieving precise and reliable results in accordance with ASTM F88-15 standards. These tests are vital to maintaining the highest quality standards in the healthcare industry and ensuring the safety of patients.
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