ASTM D 903 Test Standard Used for Medical Packaging

Medical packaging must be considered as important as the medical device itself. Its integrity and quality must be tested and given equal attention and should not be considered secondary to the device. One of the basic testing standard used for quality assurance testing is ASTM D 903. It is used for conducting peel-seal strength test in packaging material.

Why conduct seal strength test for medical packages?

When the quality assurance testing of packaging is mentioned, the first stage that comes to the mind of many testing lab technicians is the mechanical testing. It is the most vital and non-negotiable part of package testing. And when it comes to the seal strength of sterile medical packages, it is important that it must be highly regulated due to the risk of getting contaminated and pose life risk in further use. Many medical devices are sterilized before packaging so that they can be immediately utilized by doctors once opened. The seals used for this type of packaging often include a flexible barrier which is attached to an advanced adhesive. To ensure quality it is vital to test the seal strength so that the medical device stays sterile.

The medical package testing is conducted to ensure that a perfect seal has been generated blocking the sterile medical device from contaminants present in the surrounding atmosphere. The weak or incomplete seal regions will permit the entry of contaminants into the sterile medical package. Seal strength measurement of the medical packaging can reduce the risk of such contamination. For the same purposes, it is also important to maintain a constant seal strength of the packages across a quality uniform seal. The most renowned and prime testing standard used for conducting the quality evaluation of packaging is ASTM D 903 method.

The standardized testing method

This testing standard is used for determining the peel or seal strength of flexible barrier packaging. Calculating the peel & seal strength allows the testing labs to acquire quantitative measurements regarding the packaging process. In this test, the average force to open the seal and peak load during the test is computed using a precisely designed peel strength tester. It is used to quantify the permanence of adhesion or peel-ability of self- adhesive pressure sensitive materials. The testing can be conducted at 90° or 180° angle fixture to generate real-life peeling simulation. To conduct the test procedure, a sample is placed in the machine and is pulled from one particular direction to check the adhesion strength of the specimen with a specified speed. This form of testing is best when not operated manually and is fully automated. The readings of the test in an automated system can be observed in digital form on the display screen of the machine. Many labs conduct peel strength test not only to obtain related force data required to open the package but also to calculate the consistency of the packaging process and other factors that could affect the strength of the package seal, such as a sterilization process or its shelf-time. A high-quality, flexible barrier sterile seal will require a continuous force in order to peel the medical package. In case the force required to remove the flexible barrier falls down, it is an indication of a poor seal or weak adhesion between the barrier the packaging. Seal strength testing of such packages is performed to ensure short-term seal strength i.e. until the time it is opened, and also to ensure that no micro-bacterial organism enters the packaging.

With an emerging medical market across the world, the packaging is an area that requires delivering standardized quality testing. As this field’s quality scale is directly linked to the life-risks if not maintained. In order to cover quality challenges and opportunities related to the same, it’s important to perform the physical testing of packages by using precisely designed instruments. Moreover, quality testing of medical packaging needs to be considered with the same thoroughness as the medical device itself. sterile processing technician

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