Product/Service

Pharmaceutical Leak Detector: MediScan

Source: TASI Group: Bonfiglioli Engineering and Sepha

mediscan product image

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:

  • 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.
  • 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.
  • 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.
  • 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.