| Title | Dye Ingress Testing Limitations |
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| URL | https://www.pti-ccit.com/ccit-fundamentals/dye-ingress-testing-limitations-and-breakdown |
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| Category | Sciences --> Medical |
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| Meta Keywords | PTI
CCIT |
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| Meta Description | Learn how dye ingress testing works, its limitations in sensitivity and reliability, and why it may fail to detect small or critical leaks in modern sterile packaging systems. |
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| Owner | PTI CCI |
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| Description |
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| Learn how dye ingress testing is used to evaluate package integrity by observing the penetration of colored dye through leaks. While simple to perform, this method has significant limitations in sensitivity and reliability, as results often depend on subjective interpretation and test conditions. Dye ingress testing may fail to detect small or critical leaks that can still compromise sterility. As sterile packaging systems become more advanced, these limitations highlight why dye ingress is increasingly unsuitable for modern validation and why more sensitive, deterministic CCIT methods are preferred.
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