Dye Penetration Testing for Medical Packaging: What You Need to Know. Blog post by Andres Dumas

November 18, 2024

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.