Container closure/integrity, bacterial or dye immersion

Container closure/integriy, dye immersion with visual analysis ISO 7864, ASTM D4991, FDA Docket 980-0021, PDA TR27

Container and Closure Integrity test using dye immersion with visual analysis

The container and closure integrity test with dye immersion with visual analysis is used to ascertain the integrity of the sample container.  This test entangles immersing the samples in a solution of Methylene blue dye. The sample containers are tested with vacuum immersion and investigated for confirmation of leakage using visual analysis.  The test method covers the container and closure integrity using dye immersion test with visual analysis.  This test method conforms to the standard covered in ISO 11607 “Packaging for terminally Sterilized medical devices”.

Container closure/integrity, dye immersion withUV/Vis ISO 7864, ASTM D4991, FDA Docket 980-0021, PDA TR27

Container and closure integrity test using dye immersion with Ultraviolet spectrometers.

The container and closure integrity test with dye immersion using ultraviolet spectroscopy can ascertain the integrity of container test samples.  This test immerses the samples in a solution of methylene blue dye and then placed under a vacuum for 30 minutes.  After exposure the samples are then analyzed using ultraviolet spectroscopy to determine if the dye penetrated the container resulting in a test failure.  

Container closure/integrity, bacterial immersion ISO 7864, ASTM D4991, FDA Docket 980-0021, PDA TR27

This test is designed to evaluate the adequacy of the closure in maintaining a sterile barrier.  Integrity maintenance is evaluated through liquid immersion of the containers (containing sterile growth medium) into a solution containing a microbial challenge (Brevundimonas dimunta ATCC #19146) for a specified amount of time, pressure, and vacuum. Containers are then removed from the challenge, rinsed, incubated, and examined for growth. Controls are performed with each challenge.