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Heading towards 100% CCI testing

Container Closure Integrity testing can lead to significant cost reductions and proves to be less time-consuming than most sterility test methods

In recent years, Container Closure Integrity (CCI) testing has steadily moved up the pharmaceutical manufacturing agenda. Apart from reducing the risk of product recalls, CCI testing proves to be less time-consuming than most sterility test methods and can lead to significant cost reductions.

 

Not only ampoules are prone to CCI defects. Other primary packaging types such as vials, cartridges and syringes are even more demanding, as they consist of several different parts involving more potential risks. Consequently, the United States Pharmacopeia (USP) has revised its General Chapter 1207, calling for more quantitative, validated CCI test methods.

 

The revision will not necessarily lead to the development of entirely new equipment. In fact, a wealth of technologies is available on the market. They range from high-voltage leak detection (HVLD) to headspace analysis (HSA).

 

To select the appropriate testing method for each product and container, a thorough understanding of the product is paramount: is it sensitive to oxygen or moisture? Is a specific vacuum level required? What is the structure of the molecule? What is the critical defect size that must be detected to keep the product sterile and stable across its entire shelf life?

 

Far more than a machine

Here, equipment suppliers who know the market and regulatory requirements, and have a broad portfolio in hand, are of invaluable assistance. For instance, Bosch Packaging Technology offers a large selection of different machines and CCI technologies combined with the required expertise.

 

Together, we will select the suitable technology in line with regulatory compliance and define the desired speed and precision. This way, you will receive a solution tailored to the exact requirements of your API, dosage form, container type and size.

 

Links

  • Would you like to learn more about our CCI expertise? Read our expert article in our customer magazine packazine (article starts on page 4).
  • For more information, please follow this link.

 

Contact
Mahmoud Hamada
Business Development Inspection Technology
+49 7951 402-1620
mahmoud.hamada@de.bosch.com

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2 Responses

  1. Mahmoud Hamada says:

    Dear Amit,
    thank you for your post.
    1. The validation of this method can be done using certified samples with defined mixture of gases, defined pressure levels or defined electrical resistance.
    2. A complete replacement of sterility test by CCIT is not foreseen. This topic would need a deeper discussion, so please feel free to contact us so we can go through it in details.

    Regards,
    Mahmoud

  2. Amit gupta says:

    Dear All,
    I have few query’s regarding CCIT:
    1. How do we perform validation of this method
    2. can we replace sterility test based on CCIT.

    Thanks
    Amit gupta

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