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Manufacturing Technology Insights | Friday, June 18, 2021
Sepha has accomplished micro leak detection down to one millimeter (1m) with the development of a new high-performance leak tester for CCIT applications.
FREMONT, CA: With the formation of a new high-performance leak tester for CCIT (Container Closure Integrity Testing) applications, Sepha has accomplished micro leak detection down to one millimeter (1m). In addition, the new Multi-Q HD unit, which uses the vacuum decay testing methods, pushes integrity testing to the next level, allowing for ultra-sensitive, non-destructive detection of faults in pharmaceutical containers. This improved testing capability is in response to increased demand from parenteral formats, which are seeing exceptional growth due to international Covid-19 vaccination programs.
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Explaining the context to the development of the new Multi-Q HD, Sepha's Managing Director, Paul Smith, says, "Testing to 5µm used to be the benchmark for CCIT, but in recent years, we have witnessed a drive from the industry to raise the bar for increased integrity test sensitivity. Since the pandemic, this trend has really gained momentum." He continues, "Intercepting defective containers before they reach end-users or patients is important for any pharmaceutical, but for short shelf life, highly sensitive, injectable products it is absolutely crucial. Ingress of air through micro cracks and pinholes has implications for product efficacy and safety, therefore pharmaceutical manufacturers cannot afford to be anything less than 100% confident in the integrity of their parenteral formats. We view it as our responsibility to provide the technology that can instil this level of confidence. With this in mind, we set ourselves the target of guaranteeing micro leak detection down to 1µm and we are proud and delighted to report that we have achieved that goal."
Sepha's engineers can accomplish this step-change in detection performance with an innovative sensor configuration that filters out interference.
"With a standard sensor, there is a certain level of signal-to-noise ratio that makes it difficult to pick up the slight rise in pressure that is usually indicative of a micro leak. At the heart of the Multi-Q HD unit is sensor technology with an improved signal-to-noise ratio, so that even the most minuscule pressure differential is discernible. The sensor is also located at the point of measurement, which yields a faster response and more sensitive results compared to alternative technologies," explains Smith.
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