Pharmaceutical Leak Detector: MediScan
Source: TASI Group: Bonfiglioli Engineering and Sepha
MediScan is a tool-less, non-destructive leak detection device for non-porous pouches, sachets and medical device packaging.
The MediScan leak detection device incorporates the leak detection technology and software, developed by Sepha, that is utilized on a daily basis by top global companies to ensure the product integrity in their pharmaceutical prodction lines.
Benefits:
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Non-destructive test generates less waste and bigger product yield
- The non-contact method is clean and dry, unlike other destructive leak testing methods (eg Methylene Blue Dye Test), and does not destroy test product or packaging.
- Tested product can be retrieved from faulty packs and repackaged.
- Packs which pass the leak test can be put back onto the production line.
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Accurate, validatable results for each pouch or sachet
- Detects holes down to 10 microns.
- Automatically stores product-specific data in pre-designated file locations. BlisterScan verifies the product to be tested before each cycle.
- Totally objective results as no operator intervention is required
- Pass or fail criteria can be set to the same micron level as your existing Methylene Blue Dye Test.
- Result data is stored and can be printed or downloaded to other storage devices for further analysis.
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Quicker troubleshooting for line set-up to reduce rejects
- Fast test cycle means that leak testing can be carried out more frequently.
- Earlier detection of leaks allows line operators to investigate the cause of the failed seal more quickly, so fewer faulty packs are produced on the line.
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Easy to use
- No special technical skills required.
- Touch screen operator interface.
- 30 second product changeover.
Features
- Non-destructive seal integrity and leak detection device
- No tooling required, making it hightly flexible across a number of pack types and sizes
- Capable of detecting weak seals, channel leaks and holes down to 10 micron.
- Table top device
- Capable of handling wet or dry non-porous packages up to 100mm x 200mm x 250mm
- Easy operator use via touch screen interface and easy load chamber
- Capable of storing multiple test methods for up to 10, 000 product types
- User defined password protectionensuring multiple operator use
- Fully Validatable system
- Production of objective and repeatable results
- Test results can be printed, exported via USB (x2) or integrated into local quality control system via Ethernet cable
- Fast, efficient test speed
- Audit data available and fully 21 CFR part 11 compliant.
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