- Jill Colna
- Jul 28, 2021
Ensures Sterility and Integrity of Products, Which Can Have a Major Impact on Patients’ Health
Clara, Ireland – July 28, 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 visual inspection and dye penetration tests. 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 second part of this series, we will examine two common tests often used to determine package seal integrity – bubble leak and seal strength. Nelipak Laboratory Services, a fully ISO 17025 accredited lab, provides testing services to healthcare companies from all manufacturing sectors.
Bubble leak testing, which is carried out at Nelipak Laboratory Services to the ASTM Standard F2096, is one of the most common tests done to examine the integrity of packaging materials. While similar to dye penetration testing, bubble leak testing has a distinct advantage as it can detect the presence of holes not only in the product seal but also the main body of the packaging, which dye penetration testing may not detect. A destructive test by nature, bubble leak testing works by inflating the packaging underwater to a certain pressure and checking for the presence of streams of bubbles coming from the surfaces of the packaging. A continuous stream of bubbles is an indication of a breach in package barrier integrity in the packaging.
Seal strength testing (also referred to as a peel test) is a test performed to measure the strength of the seal of a package. The method at Nelipak (based on standard ASTM Standard F88/F88M) determines the peel force required to separate the seal. The results of this test have many helpful applications such as a review of a sealing process to ensure a consistent seal has been produced or checking that a seal produced is not too weak or too strong. There are several methods used to perform seal strength depending on the material and packaging type. However, the basic principle remains the same. A sample of the seal is cut from the package, often one from each seal of the package, and placed between two grips. The seal strength tester measures the forces as the two grips pull the seal apart and an average value is calculated. This seal strength value can then be used to determine if the sealing process is both consistent and strong enough for the customer’s needs.
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
Follow us on:
Nelipak Marketing Contact:
Director of Global Marketing
Nelipak Healthcare Packaging
SVM Public Relations