VisionScan 3D is a non-destructive, tool-less blister leak test for all foil types.

The Sepha VisionScan 3D is a leak test for blisters that takes non-destructive leak testing to a new level. The next generation machine is built around a new and patented 3D measurement technique to test the integrity of pharmaceutical blister packs.

The 3D technology is used in combination with differential pressure and vacuum and enables the machine to detect leaks in individual blister pockets as low as 5μm (pack and material dependent). The new technology can be applied to all foil types, including busy text patterns. Different pack configurations can be tested with one setting, allowing for easy calibration, quick set up times and a streamlined validation process across different foil types.

The system requires no tooling, while the large test area of 297x210mm enables multiple blister packs to be tested simultaneously. It is ideal for operations where multiple product changes are required. The machine utilizes the principle of vacuum deflection according to ASTM standard F3169-16. Compared with previous models (including the Blister Scan and VisionScan) this test principle has not changed. It is the new measurement technique, the 3D sensor that now creates the profile.

The VisionScan 3D offers pharmaceutical manufacturers a flexible, reliable, deterministic and cost saving alternative to a destructive leak test for blisters. The method does not affect the integrity of the blister pack, allowing packs that have passed the test to be returned onto the production line.

 

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Sepha VisionScan leak test for blisters

Features

  • Non-destructive, deterministic blister leak test device designed to test all foil types
  • Incorporates patented 3D technology that can detect leaks in individual blister pockets, channel leaks and weak seals down to a 5μm laser drilled pin hole (pack and material dependent)
  • Tool-less device making it ideal for production lines running multiple products
  • Large test area (297x210mm) provides high throughput
  • Can test multiple packs per test cycle
  • Can test packs that contain tablets / capsules in multiple material / design formats
  • Streamlined validation process for different foil types
  • Rapid test time down to 60 seconds for micron holes and as low as 30 seconds for gross holes
  • Simple operator use via a touch screen interface
  • Operating system can store unlimited product types
  • Network connectivity to a central server
  • Can form part of 21CFR part 11 compliant system
  • Capable of storing and exporting data for audit and quality control purposes
  • Active Directory and flexible reporting built-in
  • Pack type
    Blister Pack
  • Test Area
    297mm x 210mm
  • Measurement Range
    Will detect defects down to 5μm (pack & material dependent)
  • Test Cycle
    Typically from 30 seconds for gross test and from 60 seconds for decay
  • Operation
    Semi-Automatic
  • Construction
    Anodised Aluminium, Acrylic and Polyurethane Case
  • User Interface
    18.5” Full HD, 1080 x 1920 pixels with PCAP touch screen
  • Utilities
    240-100v AC single Phase, 220W Compressed Air: Min. 200L/min at 0.6Mpa [ISO8573- 1:2010 CLASS 2]
  • Configuration
    4x USB ports, 1 x Ethernet port
  • Tooling Changeover
    Tool-less
  • Audit Compliance
    Can be run in compliance with 21 CFR Part 11
  • Machine Dimensions
    691mm (L) x 489mm (W) x 701mm (H)
  • Weight
    Machine: 68kg Shipping Weight: 110kg
  • Warranty
    Supplied with a 12 month warranty. (Extended warranties are available for additional support.)

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 Quality Assurance procedures for your blister packaging line. Objective seal testing maintains compliance and ensures the integrity of the packaging process. VisionScan 3D ensures protection from moisture, air and bacteria and allows investigation of atypical results.

Reduce production rejects
Minimise reject blisters 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 volumes of faulty blisters are produced.

Sepha Leak-Testing

Non-destructive test generates less waste and bigger product yield

  • The test 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

Tool-less device

  • Can test multiple pack formats as no tooling is required

Accurate, validated results for each pocket

  • Detects holes down to 5μm*
  • Totally objective results as no operator intervention is required
  • Pass or fail criteria can be set to the same micron level as your existing Blue Dye Test.
  • Result data is stored and can be printed or downloaded to other storage devices for further analysis.

*Pack and material dependent

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.

Fast payback by reducing waste

  • Users of the Sepha VisionScan 3D can expect a ROI of less than one year when replacing the methylene blue dye test

Easy to use

  • No special technical skills required.
  • Touch screen operator interface.

 

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