MediScan is a tool-less, non-destructive leak detection device that identifies leaks as small as 10μm in non porous:
Medical device packaging
It incorporates leak detection technology and software (developed by Sepha) and is used daily by leading global pharmaceutical companies to ensure product integrity in their production lines.
Non-destructive seal integrity and leak detection device
No tooling required, making it highly flexible across a number of pack types and sizes
Capable of detecting weak seals, channel leaks and holes down to 10μm*
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 30,000 product types
User defined password protection ensuring multiple operator use
Fully validated 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.
- Acitve Directory and OPC connectivity abailable on request
* Pack dependent
** Product dependent
Drug stability testing in laboratories
R&D departments test materials to ensure the correct materials are used to protect new products from contamination by moisture, air and bacteria.
QA testing of packaging processes
Build leak tests into the Quality Assurance procedures for your packaging line. Objective seal testing ensures the integrity of the packaging process.
Reduce production rejects
Minimise reject pouches and sachets and waste disposal created in pharmaceutical production and packaging facilities by carrying out leak testing more frequently. Earlier detection of a leak means line operators can troubleshoot the cause of a leak before large volume of faulty packages are produced.
Non-destructive test generates less waste and bigger product yield
The non-contact method is clean and dry, unlike other destructive leak testing methods (e.g. 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 10μm.
Automatically stores product-specific data in pre-designated file locations. MediScan 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.
- 304 Stainless Steel Casework
- Pack type
- Sachets, pouches, bags, MAPs and flexible packaging (non-porous)
- Pack Dimensions
- Up to 250mm (L) x 200mm (W) x 100mm (D)
(9.8" x 7.9" x 3.9")
- Test Cycle
- From 20 seconds
- Easy to use operator touchscreen interface
- Machine dimensions
- 700mm (W) x 490mm(L) x 560mm (H) mm
(27.6" x 19.3" x 22")
- Machine weight
- Shipping weight
- Approx tooling changeover
- No tooling required.