Why test medical
packaging for seal integrity?
Seal
integrity is essential when evaluating the safety and shelf life of medical
device packaging. A high-quality seal prevents microorganisms from entering
through weak points, known as "channels," which can form due to
various factors. These may include incomplete adhesive activation, premature
movement of the package before adhesive curing, poorly maintained sealing
equipment, or damage to the seals during transportation or handling. If
channels exist in the seal, there is a significant risk of contamination by
microorganisms, which can compromise the sterility of the medical device and
pose serious health risks to patients.
Regulatory
requirements
Under
the Code of Federal Regulations (21 CFR 820.130), manufacturers are
required to design packaging and shipping containers that protect medical
devices from damage or alteration during typical conditions of processing,
storage, handling, and distribution. This regulation holds manufacturers
accountable for maintaining the sterile barrier's effectiveness, emphasizing
the critical role of integrity testing to safeguard patient safety. The FDA
highlights the importance of robust stability protocols to prevent microbial
contamination over time, recommending validated package integrity tests, such
as the dye penetration method, as outlined in its Container and Closure
System Integrity Testing Guidance.
Similarly,
Health Canada enforces stringent standards for medical device packaging to
ensure sterility and product integrity. The Canadian regulatory framework
aligns with internationally recognized standards, including ISO 11607-1 and ISO
11607-2, which provide detailed requirements for materials, sterile barrier
systems, and validation processes for terminally sterilized packaging. Within
this standard, Seal Leakage Testing through the Dye Penetration method is
specifically listed as a recommended approach to assess seal integrity and
demonstrate compliance with ISO 11607.
What is the dye
penetration method?
The
dye penetration method is a highly effective way to detect leaks in medical
packaging seals and described in details ASTM F1929. This method can identify leaks as small as channels formed by
a 50 µm (0.002 in.) wire. The process involves applying a specially formulated
dye penetrant solution to the seals. The packaging is then examined for
microchannels indicating leakage.
What
packaging materials can be tested with this method?
This
method is ideal for testing porous materials, especially where seals are formed
between a transparent material and a porous sheet. The dye must stay on the
seal for at least 5 seconds without discoloring the surrounding area. Certain
materials, such as uncoated paper, are more prone to leakage and require
thorough evaluation.
Why
Choose SteriLabs?
With
our industry experience and expertise in seal leakage testing, we ensure your
packaging maintains integrity and sterility throughout its lifecycle,
safeguarding health outcomes.
Whether
you want to test your current packaging, are still deciding on the ideal one
based on your sterilization method and device, or are looking to make
improvements, we’re here to help. Contact us to learn how we can support
your medical packaging needs.
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