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Container Closure Integrity Testing (CCIT) By Microbial Challenge

Container Closure Integrity Testing (CCIT) By Microbial Challenge

  • Container Closure Integrity Testing (CCIT) assesses the ability of a container to keep out microorganisms. It is used to evaluate the seal integrity of primary packaging materials for sterile products.
  • Rigid containers are often tested as part of a stability study to ensure that the closure of the container can maintain a sterile barrier. The regulatory agencies recommend performing a container closure integrity test in lieu of a sterility test as a component of a stability testing protocol.
  • The samples are immersed in a vacuum chamber filled with media inoculated with microbial culture (Brevundimonas diminuta) and either pressure or vacuum is applied over the samples. The positive controls are punctured with a microtube to allow the entry of microbes into the vials. Test samples that show turbidity after incubation are considered to be compromised for seal integrity.

Our Antimicrobial Effectiveness Testing Services Include:

  • Test Methodology:

    Performing antimicrobial effectiveness testing in accordance with industry standards such as USP , EP 5.1.3, and JP etc. to assess the performance of preservatives and antimicrobial agents in pharmaceutical products.

  • Microbial Challenge Testing:

    Introducing specific microorganisms into the product and monitoring the effectiveness of the antimicrobial agents over time to ensure they can inhibit or kill the microorganisms.

  • Product Types:

    Conducting tests on a wide range of pharmaceutical formulations, including topical products, oral medications, injectables, and ophthalmic solutions.

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