Container Closure Integrity Testing using Vacuum Decay and Pressure Decay Method

Introducing Brio Pharma Technologies Pvt. Ltd. and Pentagon Automation and Assemblies Pvt. Ltd., an indigenously developed state-of-the-art machine made in India in the realm of container closure integrity testing (CCIT) solutions. Our technology of container closure integrity testing encompassing Pressure Decay, Vacuum Decay, and Pressure+Vacuum Decay combination machines helps meet Pharma companies with the required regulatory standards in non-destructive CCIT methodology, with a focus on in-process, statistical tabletop and standalone machine with CFR part 11 compliance and high accuracy, ?inline or offline high-speed machine up to 300PPM, in-process, and online machines redefine efficiency and reliability in pharmaceutical manufacturing.

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At Brio-Pentagon, we take pride in our commitment to innovation and excellence. Our Make in India machines epitomize state-of-the-art technology, ensuring compliance with stringent regulatory standards such as ASTM F2338-05" Recognized by FDA (List No 014).

Moreover, our offline non-destructive Vacuum Decay and Pressure Decay machines align seamlessly with Annex-1 guidelines, offering pharmaceutical companies unparalleled peace of mind in their quality assurance processes.

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Let's examine the five points outlined in Annex 1 concerning Container Closure Integrity (CCI)

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Annex 1, 8.21 - Final containers should be closed by appropriately validated methods

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Annex 1, 8.22 - Where final containers are closed by fusion, e.g. Blow-Fill-Seal (BFS), Form-Fill-Seal (FFS), Small and Large Volume Parenteral (SVP & LVP) bags, glass or plastic ampoules, the critical parameters and variables that affect seal integrity should be evaluated, determined, effectively controlled and monitored during operations. Glass ampoules, BFS units and small-volume containers (≤100 ml) closed by fusion should be subject to 100% integrity testing using validated methods. For large-volume containers (>100 ml) closed by fusion, reduced sampling may be acceptable where scientifically justified and based on data demonstrating the consistency of the existing process, and a high level of process control. It should be noted that visual inspection is not considered an acceptable integrity test method.

Annex 1, 8.23 - Samples of products using systems other than fusion should be taken and checked for integrity using validated methods. The frequency of testing should be based on the knowledge and experience of the container and closure systems being used. A scientifically justified sampling plan should be used. The sample size should be based on information such as supplier management, packaging component specifications, and process knowledge.

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Annex 1, 8.24 - Containers sealed under vacuum should be tested for maintenance of vacuum after an appropriate pre-determined period prior to certification/release and during shelf life.

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Annex 1, 8.25 - The container closure integrity validation should take into consideration any transportation or shipping requirements that may negatively impact the integrity of the container (e.g. by decompression or extreme temperatures).

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In conclusion, Brio-Pentagon brings to you container closure integrity testing like Pressure Decay, Vacuum Decay, and Pressure-Vacuum Decay machines. Committed to innovation and compliance, we ensure reliability and efficiency in pharmaceutical manufacturing, meeting the highest industry?standards.