Dye penetrate solution for astm 1929

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With the included laminated reference-guide you can quickly identify a host of seal failures. Shorten essential pouch testing cycles by eliminating mixing and measuring messy dyes, which slows your work flow. A recent survey of medical device packaging engineers by packaging digest reveled the dye Penetration is now used by We also now offer bulk Boston bottles in 8oz, 16oz or 32oz sizes to accommodate your testing work flow. Stay compliant with regular dye testing.
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Dye Penetration Testing

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ASTM F() Standard Test Method for Detecting Seal Le

Understanding the distinctions between these two sterile barrier performance tests helps you decide which is best suited to your SBS. Using the right test for your medical device or pharma product saves time, money and stress by protecting you against the need to retest. Background: Adopted as an ASTM standard in , the current version of the standard became effective in By inflating the package under water to a predetermined pressure, the technician observes for even tiny sources of streaming bubbles that indicate a failure. Fails can include gross leaks, pinholes substrate holes or channels.
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Sterile Barrier Testing: Bubble Leak or Dye?

Historical Version s - view previous versions of standard. Work Item s - proposed revisions of this standard. More F
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A dye penetrant solution is applied locally to the seal edge to be tested for leaks. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. Harmful biological or particulate contaminants may enter the device through leaks.
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