Parenterals, high risk or proposed USP <797> Sterile Compounding, Category 2 compounds can be tested for container closure integrity to demonstrate sterility and stability. Container Closure Integrity testing for USP <1207> Sterile Product Packaging Integrity Evaluation is performed per PDA (Parenteral Drug Association) Technical Reference (TR) No. 27 Pharmaceutical Package Integrity. Testing utilizes high density microbial challenges of Brevundimonas diminuta, a very small rod shaped organism, for penetration to the container closure seal. Failure of microbial penetration into the container is the acceptance criteria for demonstration of closure integrity. This type of testing is the basis of stability verification in parenterals and also Beyond-Use-Dating (BUD) extension in Compounded Sterile Preparations (CSPs).
MRA has performed container closure integrity testing on vials, syringes, large volume parenterals and IV bags for customers nationwide. Integrity testing is protocol based and utilizes microbial immersion methodology.
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