Sepha VisionScan Leak Detection Device

  

 VisionScan

 

VisionScan is a non-destructive, tool-less leak detection device for pharmaceutical blister packs.

The Sepha VisionScan is a non-destructive, tool-less, deterministic blister leak test device. Using the latest camera imaging technology in combination with differential pressure, it can detect leaks in individual blister pockets as low as 7 micron*. The machine offers pharmaceutical manufacturers a flexible, reliable, objective, deterministic and cost saving alternative to destructive blister pack test methods such as blue dye.

The VisionScan is simple to operate and requires no tooling, making it ideal for high volume pharmaceutical manufacturers and packagers where high levels of quality control, cost reduction and multiple product changes are required.

Features

• Non-destructive, deterministic seal and leak detection device designed for blister packs
• Incorporates imaging technology that will detect leaks in individual blister pockets, channel leaks and weak seals equivalent to a 7μm (Pack and material dependent) laser drilled pin hole
• Tool-less device making it ideal for production lines running multiple products
• Can test multiple packs per test cycle
• Connectivity: has the ability to connect to an OPC Server or database
• Rapid test time down to 10 seconds for micron holes and as low as 6 seconds for gross holes
• Operating system can store unlimited product types
• Simple operator use via a touch screen interface
• Can test packs that contain tablets / capsules in multiple material / design formats
• Objective, repeatable pack test for each product
• Capable of storing and exporting data for audit and quality control purposes
• Can form part of 21 CFR part 11 compliant system
• Compact and lightweight, mobile table top device with improved environmental impact
• Active Directory and flexible reporting built-in
  

Benefits

Non-destructive test generates less waste and bigger product yield

• The image scanning 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 7μm*
• 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 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.

Applications

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 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.

Specifications

• Pack type
  Blister Pack
• Test Area
  210mm x 165mm
• Measurement Range
  Will detect defects down to 7μm (pack & material dependent)
• Test Cycle
  10 seconds for micron holes, 6 seconds for gross holes
• Operation
  Semi-Automatic
• Construction
  Anodised Aluminium and Acrylic – capped ABS top Cover
• User Interface
  12” WXGA TFT display, 1280 x 800 pixels with resistive touch screen
• Utilities
  - Electrical 24v DC 4A - Air: Min. 200L/min at 0.6Mpa [ISO8573-1:2010 CLASS 2]
• Configuration
  2 x USB ports, 1 x Ethernet port
• Tooling Changeover
  Tool-less
• Audit Compliance
  Can be run in compliance with 21 CFR Part 11
• Machine Dimensions
  Width: 455mm (17.9”) Depth: 440mm (17.3”) Height: 520mm (20.47”)
• Weight
  Machine: 40kg (88lbs) Shipping Weight: 80kg (176lbs)
• Warranty
  Supplied with a 12 month warranty. (Extended warranties are available for additional support.)

Reference : sepha.com

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