- Jill Colna
- Jun 17, 2021
Ensures Sterility and Integrity of Products, Which Can Have a Major Impact on Patients’ Health
Clara, Ireland – June 18, 2021 ― Nelipak® Laboratory Services (“Nelipak”), a leading provider of healthcare packaging testing for the medical device and pharmaceutical sectors, provides package integrity testing services at our Clara, Ireland and Venray, the Netherlands locations for healthcare companies from all manufacturing sectors.
Package integrity is a major concern for manufacturers, particularly those in the medical device and pharmaceutical industries where the sterility and integrity of products can have a major impact on patients’ health. Two of the most common package integrity tests that our team performs for customers are visual inspection and dye penetration.
The visual inspection of products (performed at Nelipak Labs to the ASTM F1886/F1886M standards) is the most common way to check for package integrity across multiple industries. Visual inspection, though a simple test, provides very useful information for a manufacturer to uncover potential failures in their packaging process. ASTM F1886/F1886M focuses mainly on identifying visual characteristics of package seals, which can indicate a possible problem with the integrity of the package sealing process.
A full inspection of the seal and package involves the identification of abnormal characteristics in the package such as unsealed areas, narrow seals, over-sealed areas, channels in seals, cracks, wrinkles, tears, holes or contaminates. Customers often provide additional internal criteria for their inspection such as label legibility, device damage, specific seal widths, etc.
Dye penetration testing (carried out at Nelipak Labs to the ASTM F1929 standard for porous materials and ASTM F3039 standard for non-porous materials) is frequently performed to ensure the seals of a pouch or blister pack are uniform and whole. This test helps manufacturers determine if their sealing process or a package supplier’s sealing process is fit for purpose.
This test works to identify channels indicating an integrity issue in the package seal using a coloured dye solution. The procedure involves a variety of methods to test different types of packaging such as injection method, edge dip, and roller method. All the methods look for the same criteria to see if the dye solution passes through the seal of the package at any point. The passing of the dye solution through the seal indicates the presence of a channel, which means the seal of the package is not whole across the package.
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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