A container closure system refers to the sum of packaging components that together contain and protect the drug dosage form. Regulatory agencies require that companies must demonstrate that the container closure system used to package a drug or medical device will protect the product from microbial contamination or preserve the sterility for the life of the product. The product container closure system can be tested by physical (Dye Leak test) or microbiological means (microbial immersion test).
The dye leak test is performed by immersing the samples in a vacuum chamber filled with methylene blue dye. After exposure to the dye and test conditions, the samples are inspected for the presence of the dye.
The microbial challenge test is performed by immersing the simulated samples filled with Tryptic Soy broth in a media broth inoculated with B. diminuta. The samples are incubated for 14 days at 30-35°C and then inspected for contamination.
Typically, the test is performed using the same number of samples as the sterility test, plus positive and negative controls.
|Assay Description||Service Code|
|Microbial Immersion test||ML40|
|Dye leak test||ML41|