SEPHA

SEPHA

Unit 25 CarrowreaghBusinessParkCarrowreaghRoad,DundonaldBelfast, BT16 1QQNorthern Ireland

PakScan

PakScan

PakScan

PakScan is a non-destructive, multi-product seal integrity tester for pouches, sachets and flexible packaging.

Using force decay technology, the Sepha PakScan is a non-destructive, multi-product seal integrity tester developed to verify package integrity of non-porous flexible packaging.

The machine offers a clean and dry leak detection test solution for modern manufacturers and packaging companies that pack dry product in pouches, sachets, bags and stick packs containing dry powder or solid components/medical devices.

The Sepha PakScan is a non-destructive test method. The machine performs a dry seal integrity test enabling manufactures to recover packs that have passed the leak test and return them to the production line.

The system can identify gross holes, leaks and weak seals down to 10μm* in up to 10 packs simultaneously within 30 seconds. The method provides deterministic and objective results, visualised on the result screen via a pass or fail for each individual packet. The software is developed in line with FDA 21 CFR Part 11 regulations enabling manufactures to store and export data for audit purposes, while protecting reports from being edited or deleted.

The Sepha PakScan is suitable for flexible packaging made from non-porous material including PVC, PVDC, Aclar and Aluminium foils and laminates. The system offers standard configurations to include 3, 4, 5, 6, 8 or 10 packs and can be customised to accommodate larger packs.

Features

  • Non-destructive seal integrity and leak detection device that uses force decay technology to detect weak seals and holes down to 10µm (pack and material dependent)
  • Can test up to 10 packs simultaneously (standard configurations: 3, 4, 5, 6, 8 & 10 packs)
  • Capable of handling dry, non-porous packages
  • User defined password protection ensuring multiple operator use
  • Easily validated system
  • Repeatable test with deterministic and objective pass/fail results
  • Test results can be printed, exported via USB (2x) or integrated into local quality control system via Ethernet cable
  • Active Directory and OPC connectivity available on request
  • System can be run in compliance with 21 CFR Part 11

Technical Spec

  • Pack Type
    Sachets, pouches, bags and MAP (flexible, non-porous materials)
  • Pack Size
    See table in Features
  • Test Cycle Time
    From 20 secs.
  • Measurement Ranges
    Down to hole size of 10 micron (pack and material dependent)
  • Operation
    Semi–automatic
  • Machine Construction
    304 Stainless Steel Workstation, Anodised Aluminium Test Area. All product contact areas are cGMP.
  • Utilities
    – Electrical: 110/230V Single Phase AC 50/60Hz – Air: Min. 20L/min at 0.6Mpa [ISO8573-1:2010 CLASS 2]
  • Configuration Options
    2x USB Ports, 1x Ethernet Port
  • User Interfaces
    12.1 inch HDMI resistive touchscreen (1280 x 800 resolution)
  • Tooling Changeover
    Approx. 1 minute
  • Audit Compliance
    System can be run in compliance with 21 CFR Part 11
  • Machine Dimensions (excl. screen)
    670mm (L) x 760mm (W) x 882mm (H)
  • Machine Dimensions (incl. screen)
    670mm (L) x 1042mm (W) x 1195mm (H)
  • Machine Weight
    200kg
  • Shipping Weight
    260kg
  • Warranty
    Supplied with a 12-month warranty. (Extended warranties are available for additional support).

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