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CCIT technology: product integrity, people safety
CCIT technology: product integrity, people safety

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05 Março 2021

CCIT technology: product integrity, people safety

The challenge of choosing the proper method for each product requires a comprehensive approach.

Recent regulatory guidance and requirements (e.g., EU GMP Annex1 and United States Pharmacopeia – USP) are influencing and triggering changes in industry best practices for CCIT (Closure Container Integrity Testing). Historically, good CCI has been linked to the guarantee of sterility as it plays an important role in maintaining the sterility and stability of sterile injectable products.


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Good CCI is necessary also to monitor critical headspace gas conditions (e.g., in the case of the Freeze-dried product). However, the context of CCI has become broader over the years. Visual inspection is not considered an acceptable integrity test method, although it can be used as a valuable indirect tool to suggest or predict integrity failure. A raised rubber stopper or a crack are common cases. The challenge of choosing the proper method for each product requires a comprehensive approach.

Multi-technology strategy that the Antares Vision Group offers to allow effective CCI testing.

In this scenario, the synergy with Convel has allowed the Antares Vision Group to strengthen its technological know-how, providing CCIT solution based on several technologies. An increasingly complete solution, with a single partner able to satisfy every market requirement in the field of Leak Detection. The offer covers a wide range of Container Closure Integrity Testing solutions, which checks the integrity of the container closure and allows to effectively, safely and reliably identify possible defects that compromise the quality and integrity of a product, in the name of that comprehensive approach essential to determine that the product has not lost its sterility.

 

As a Group, we can guarantee to always be able to offer the best solution for each specific case, choosing the best technology and counting on our capability to offer optimized cross-technology solutions, such as High Voltage Leak Detection (HVLD), Head Space Gas Analysis (performed with LASERS working at different wavelengths), Pressure Decay Leak Detection (PDLD), Vacuum Decay Leak Detection (VDLD).

 

The simultaneous availability and the possible combinations of these technologies provide an exhaustive solution for effective CCI testing for every kind of product. A range of solutions designed to cover small, medium, and large formats and to comply with the highest standards of accuracy and reliability in reproducible controls. Discover more by watching this video!

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