Many companies have produced innovative leak test machines that present a non-destructive alternative to Blue Dye testing methods. Whether you are a pharma packaging or a pharmaceutical manufacturer of blister packs, induction sealed bottles, sachets, pouches, and medical devices, your packaging’s quality is significant to ensure drug stability, as any deficits can affect the shelf life and efficiency of the content. It would help if you counted on your leak disclosure procedures’ correctness to decrease recalls and reduce the associated costs.
It gives various non-destructive, deterministic leak testing methods specifically designed to test leaks in a wide variation of pharmaceutical packaging rapidly. Unlike the industry-standard destructive test systems like Blue Dye Methylene, testing methods are non-destructive, allowing product that has been tested to be declared to the production line. Need to explore the testing solutions and see how you can keep time and money, decrease waste, and get stable and repeatable results.
So, Shepa has delighted to announce the newest innovation, a newly patented 3D Leak Detection technology for pharmaceutical blister packs. Pointed at pharmaceutical manufacturers, the latest technology incorporates a 3D sensor to give the volumetric measurement to assess the uprightness of a range of solid pharmaceutical dose and flexible limit packaging.
The latest technology’s first application will be released with the latest non-destructive blister leak examiners, the VisionScan 3D. This next-generation machine will apply the 3D technology joined with differential pressure and vacuum to identify leaks in particular blister pockets as low as 5µm (pack and material dependent). Advanced technology can be implemented to all foil types, matt or gloss, and different text patterns can be examined with one setting, making it excellent for production lines with multiplied linguistics differences.
Some VisionScan 3D and 3D Leak Detection technology have been produced for usage within pharmaceutical packaging services and in the R&D environments. Philip Cooper, one Head of Technology and New Product Development, explanations: “We have been producing this technology for the past 12 months in acknowledgment to customer demand for a non-destructive blister leak test solution that creates it easy to test various pack configurations with one setting. Validation and review qualification processes can be time-consuming, particularly when different foil types are involved. Our 3D technology also permits for easy calibration and fast settings times to streamline the validation process”.
3D Leak Detection Technology explained
The VisionScan 3D (297x210mm) test section is wide sufficient to cover and concurrently test all blisters manufactured in one index of a typical blister line platen plate. Once the blister packs are installed inside the test area, the pack positions are automatically identified, and the test can begin.
1. Gross hole detection: The scheme first captures a quotation quantitative topographic scan, implements a vacuum, and grabs a second quantitative tomographic scan. At this point in the flow, the system determines the used vacuum response in volumetric change (mm3).
2. Micron hole detection – If extra sensitivity is needed, the system will enter the test’s decay phase. The system connects and operates a vacuum for a planned dwell time before capturing a last topographic scan through this phase. All scans are then compared and examined for volumetric pocket change using product-specific parameters.
3. Pass or fail screen – The results screen shows a pass or yields the result for each pocket. If the volumetric swap meets the required pass criteria, the pouch is deemed proper and highlighted ‘Green.’ If the bag does not meet the pass criteria, it is considered a failure. Failed pockets are shown ‘Red’ for gross defects and ‘Purple’ for micron defects.
the Regulatory accepted solution ASTM F3169-16
This VisionScan 3D is a non-destructive, deterministic leak exposure device that appropriates the principle of vacuum deflection according to ASTM standard F3169-16. This test principle has not changed compared to preceding models (including the Blister Scan and VisionScan). It is the new estimation technique, the 3D sensor that now generates the profile.
Paul Smith, Managing Director, replies: “We are very passionate about introducing our latest technology via our very initial webinar. COVID-19 has seen all major trade exhibitions beginning eliminated or postponed. This has influenced all of us in various ways, and we all must be adapted. The VisionScan 3D offered pharmaceutical manufacturers a flexible, secure, deterministic, and cost-saving alternative to destructive blister leak test methods. Our webinars will dive deeper into the technology, address examples of applications, and give an online presentation of how the VisionScan 3D and its technology goes. The webinar will please all blister pack manufacturers that are keen to perform deterministic and non-destructive leak test resolutions to develop the accuracy of their leak detection procedures and decrease cost”.