Adhesion Tests: ASTM F88/F88M and EN 868-5

ASTM F88/F88M and EN 868-5 Standards

Medical device packaging is specifically designed to maintain the sterility and safety of the product. These packages must be able to remain unopened for long periods of time and protect the products from external influences. Adhesion strength testing of packaging materials plays a critical role in evaluating the durability and functionality of these materials. In this article, we will examine the adhesion strength tests and the importance of these tests in accordance with ASTM F88/F88M and EN 868-5 standards.

What is Adhesion Strength?

Adhesion strength is a test that measures how well the sealing lines of a package withstand an applied force. In medical device packaging, it is especially critical for the sterility and safety of the product. This test assesses the opening resistance of packaging, ensuring that it provides a reliable opening for users and does not compromise the sterility of the product.

ASTM F88/F88M Standard

ASTM F88/F88M is a common standard used for adhesion strength testing of medical device packaging. This standard evaluates the opening performance of a package by measuring the resistance of the seal line to a given force.

Test Method: ASTM F88/F88M uses tensile testers to measure the opening of the sealing line of the package with a given force. The opening resistance of the package is applied at a certain angle and speed, so that the performance of the sealing line under different conditions is observed.

Test Application: The tensile force applied to the sealing points of the package and the opening speed are measured to determine whether the package meets the required durability. The ASTM F88/F88M standard evaluates the adhesion strength by observing the behavior of the tested packages during the opening or rupture process.

Importance of Adhesion Strength Testing

Adhesion strength testing is important to ensure that the package remains sterile for a long period of time and provides a safe opening experience for users. In addition, these tests determine whether the packaging can withstand external stresses during transportation, storage and use.

Sterilitenin Korunması: Ambalaj malzemesi steril kalmalı, dış ortamdan bakteri geçişini engellemelidir. Bu korumayı sağlamak için yapışma mukavemeti testleri gereklidir.
Kullanıcı Güvenliği: Tıbbi cihazların ambalajı açılırken, paket kontrollü bir şekilde açılmalı ve steril cihaz zarar görmemelidir. Yapışma gücü testleri, paketin açılma direncini ölçerek güvenli bir açılmayı garanti eder.
Dayanıklılık ve Performans: Yapışma mukavemetini ölçerek, ambalajın lojistik süreci boyunca ve son kullanıcıya ulaşana kadar bozulmadan kalmasını sağlar. Bu dayanıklılık, ürünlerin güvenilirliğini ve kalite güvencesini artırır.

To ensure the durability and safety of medical device packaging, adhesion strength tests must be performed in accordance with ASTM F88/F88M and EN 868-5 standards. These standards play a critical role in maintaining the sterility of products and ensuring user safety. Adhesion strength tests are an important step towards ensuring patient safety, ensuring that the packaging of medical devices remains sterile and durable.

EN 868-5 Standard

EN 868-5 is a European standard that applies specifically to sterile packaging for medical devices. It defines specific requirements to ensure that the packaging maintains the durability and functionality to remain sterile.

Adhesion Strength Requirements: EN 868-5 provides guidance on how to maintain the sterility of a package by the adhesion strength of the packaging material at the seal line. It stipulates that the adhesion strength must be within a certain range to ensure a reliable opening while keeping the material sterile.
Material Compatibility: This standard considers the compatibility of various material combinations to determine the adhesion strength of packaging materials. In particular, it ensures the sealing performance of polyethylene, polypropylene and other polymer-based materials in medical device packaging.

ASTM F88/F88M and EN 868-5 Test Processes

The adhesion strength tests recommended by these two standards generally include the following steps:

Packaging Sample Preparation: Test samples are prepared by a special technique to include the sealing line of the packaging.
Tensile Test Application: Specimens placed in the tensile tester are subjected to a specified speed and force. For ASTM F88/F88M, the force is usually applied at a specific angle, while EN 868-5 may include the application of force at different angles under certain conditions.
Evaluation of Results: At the end of the test, the opening resistance, breaking point and adhesive strength of the packaging materials are evaluated. The strength test measures the ability of the packaging to ensure reliable opening.

WHY NANOLAB?

Nanolab offers the most reliable and fastest solution for adhesion testing of packaging materials with its experience in the industry and strong infrastructure. It tests the adhesion strength of packaging materials in full compliance with ASTM F88/F88M and EN 868-5 standards. Thanks to ISO 17025 accreditation, analysis results are internationally recognized and material quality and reliability are accurately assessed. With its wide range of equipment and expert technical team, it completes testing processes effectively and quickly. Thanks to its regulatory expertise, the relevant standards and legal requirements are fully met. Nanolab stands out as the address where quality, reliability and speed combine in packaging materials adhesion tests.

Follow our Instagram account to be informed about our latest blog posts.