- Jill Colna
- Sep 20, 2021
Nelipak Laboratory Services Performs Package Integrity Testing to Ensure Sterility and Integrity of Products
Burst Testing and Porosity Testing Help Determine Suitability of Packaging Materials
Clara, Ireland –September 20, 2021– Nelipak® Laboratory Services (“Nelipak”), a leading provider of healthcare packaging testing for the medical device and pharmaceutical sectors, provides further details on the company’s package integrity testing process.
Previously, the team detailed burst bubble leak and seal strength. Package Integrity is a major concern for all manufacturers particularly ones in the medical device industry where the sterility and integrity of products can have a major impact on patients’ health.
In the third part of this series, we will examine two common tests often used to determine the suitability of packaging materials – burst testing and porosity testing. Nelipak Laboratory Services, a fully ISO 17025 accredited lab, provides these testing services to companies across multiple industry sectors.
Burst testing is a commonly performed test to determine a non-porous package’s ability to withstand internal pressurization. It can also be used to determine if a particular area of a package is more prone to pressure-related failures than the rest of the package. This method, performed to ASTM F1140/F1140M at our labs, involves pressurizing the packaging by continually raising the pressure until the package fails. There are different test methods for both open and closed packaging types such as pouches or blisters. This method can be performed in several ways including a “creep” test, where pressure is maintained inside the packaging for a period of time or until the packaging fails.
Nelipak Laboratory Services perform porosity testing utilising the Bendtsen method (ISO Standard 5636-3). This method determines the air permeance of porous packaging materials such as paper or Tyvek, which is the amount of air that can pass through the material. This information can be useful in determining attributes such as a package’s resistance to moisture. This method works by taking several samples of the material and analysing the airflow through both the top and bottom of the material (to take into consideration the coating or layering of the material) before calculating an average value for the whole material.
About Nelipak® Corporation
With facilities in Cranston, RI; Whitehall, PA; Phoenix, AZ; Venray, the Netherlands; Galway, Ireland; Clara, Ireland; Derry, Northern Ireland; Elsham, United Kingdom; Humacao, Puerto Rico; and San Jose, Costa Rica, Nelipak® Healthcare Packaging designs, develops and manufactures custom packaging products that provide superior protection for medical devices and pharmaceuticals. Nelipak® Healthcare Packaging customers consist of some of the largest and most reputable medical device and pharmaceutical companies in the world. With over 1,400 employees worldwide, Nelipak® is focused on delivering superior quality and customer experience through world class manufacturing at each of its locations.
Nelipak® Laboratory Services is a trade name of Nelipak Corporation
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