SEPHA

VisionScan 3D

VisionScan 3D

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

The Sepha VisionScan 3D is a blister leak test solution 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, matt or gloss. Different text patterns can be tested with one test method, making it ideal for production lines with multiple language print variations. The system is designed to allow 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 test method 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.

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

Technical Spec

• 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
• 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.)