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Sepha hits one micron target with new HD leak tester
By: Scott PR
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."
Sepha's engineers have achieved this step-change in detection performance with an advanced sensor configuration that filters out interference.
Building on Sepha's established Multi-Q leak testing platform, the Sepha Multi-Q HD is a standalone, lab-scale leak test system that can be used in combination with interchangeable attachments to fit the full range of parenteral container types available on the market today. These include glass or plastic vials, ampoules, pre-filled syringes, bottles and BFS (Blow Fill Seal) containers. Its compact, bench-top design means it can be used in the lab during drug development or for in-process batch testing to verify the integrity of containers being manufactured on the production line.
Whilst the Multi-Q HD can be configured to perform a variety of non-destructive, deterministic tests, such as pressure decay, Sepha expects that it will primarily be used for applications which require a vacuum decay test. The Multi-Q HD allows manufacturers to test in accordance with the ASTM Standard Test Method F2338-09 for vacuum decay in line with FDA consensus and USP 1207 guidelines. This non-destructive and deterministic test method provides quick, reliable and repeatable results without any damage to the product or packaging.
Another advantage of the Multi-Q HD is that it incorporates as standard, a number of features that are often only available as add-ons with other manufacturers. These include OPC connectivity, Active Directory, 21 CFR Part 11, Electronic Signatures and unlimited data storage.
The new Multi-Q HD will be launched via a live webinar on 23rd June 2021 where Sepha's packaging inspection experts will lead an online demonstration of the system.
Wednesday 23rd June: 09.00 UTC+1
Wednesday 23rd June: 14.00 UTC+1
The webinar will also be available on demand following the live event.