Package leak test Pouches, Sachets, Bags, Non-Destructive Test

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Flexible packaging

The Sepha MediScan is a tool-less, non-destructive leak detection device for non-porous pouches, sachets and medical device packaging.

The Sepha MediScan is a package leak test device developed to leak test flexible packaging. The machine is a tool-less, non-destructive leak detection device for non-porous pouches, sachets and medical device packaging.

Pouches
Sachets
Medical device packaging

The machine incorporates leak detection technology and software, developed by Sepha, that is utilized on a daily basis by top global pharma companies to leak test flexible packaging and ensure product packaging integrity.

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Features
- Non-destructive seal integrity and leak detection device
- No tooling required, making it highly flexible across several pack types and sizes
- Capable of detecting weak seals, channel leaks and holes down to 10μm (pack dependent)
- Table top device
- Capable of handling 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.
- Active Directory and OPC connectivity available on request
Technical Spec
- Pack Type
  Sachets, pouches, bags, MAPs and flexible packaging (non-porous)
- Test Area
  Up to 250mm (L) x 200mm (W) x 100mm (D)
- Test Cycle
  From 20 seconds per test cycle
- Operation
  Semi-automatic
- Machine Construction
  304 Stainless Steel Casework
- User Interface
  10″ HDMI (800×480) LCD Display
- Utilities
  Electrical: 110/230V Single Phase AC 50/60 Hz / Air: Min. 200L/min at 0.6Mpa [ISO8573-1:2010 CLASS 2]
- Configuration
  2 x USB ports, 1 x Ethernet port
- Tooling Changeover
  No tooling required.
- Machine Dimensions
  400mm(L) x 700mm (W) x 500mm (H)
- Machine Weight
  90kg
- Shipping Weight
  190kg
- Warranty
  Supplied with a 12-month warranty. (Extended warranties are available for additional support).
Benefits
Non-destructive test generates less waste and bigger product yield
- The non-contact method is clean and dry, unlike 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, validated results for each pouch or sachet
- Detects holes down to 10 microns.
- 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.
- Instant product changeover.
Force Decay
How does Force Decay testing work?

A flexible package is placed within a tool set which comprises of a strain gauge load cell, which in turn is housed within a vacuum test chamber.

Vacuum is applied to the test chamber and under this vacuum the flexible package will expand and generate an expansive force in response to the vacuum.

The strain gauge load cell measures the expansive force over time to determine if the package has a gross leak, micron leak or has no leaks.
- If there is a gross leak, no expansive force is measured.
- If there is a micron leak, an expansive force is initially measured but will start to reduce over time as the pack lets air escape into the vacuum chamber.
- If the pack is good it will expand under vacuum and remain inflated and in turn generate a constant force measurement over time.
To ensure the integrity of the pack is not affected or does not burst, a force reaction/restraining plate is used to prevent full expansion.
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