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.
For further
information regarding package integrity testing and other services, contact the
Nelipak Laboratory Services team at cla-labservices@nelipak.com or go
to our
website.
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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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Nelipak Marketing Contact:
Seán Egan
Director of Global Marketing
Nelipak Healthcare Packaging
+353-91-709-163
sean.egan@nelipak.com
Press Contact:
Sage Morander
SVM Public Relations
sage.morander@svmpr.com