Induction sealed bottles

The Sepha BottleScan is a non-destructive, tool-less multi-bottle leak tester for induction-sealed pharmaceutical bottles.

BottleScan

Do you require a leak test procedure for bottles? The Sepha BottleScan has a unique ability to test up to 4 bottles per test cycle in 30 – 90 seconds and can detect defects in bottles and inductions seals down to 15µm*. The tool-less design allows for rapid changeover between different size bottles, making it ideal for production lines with multiple products.

The system incorporates force decay technology to offer a technologically superior Quality Assurance / Quality Control check as part of cGMP.

* Bottle dependent

  • Features

    • Non-destructive inspection device for induction sealed bottles
    • Detects defects in bottles and induction seals down to 15µm (bottle dependent)
    • Tests up to 4 bottles per test cycle in a test term of 30 – 90 seconds
    • Can run in compliance with 21 CFR Part 11
    • Operating system can store up to 30,000 product types
    • No tooling required so ideal for production lines with multiple products
    • Quick, repeatable test with objective pass/fail results
    • Can handle multiple bottle sizes
    • Configurable methods allow user to decide machine sensitivity
    • Simple operator use with minimal training required
    • Audit data available
    • Active Directory and OPC connectivity available on request
  • Technical Spec

    • Operation
      Semi-automatic
    • Bottle Dimensions
      30mm(W) x 60mm (H) x to 100mm(W) x 150mm(H) (without cap)
    • Test Cycle
      30-90 seconds
    • Measurement Range
      Down to 15 microns
    • Construction
      Stainless Steel (Grade 304)
    • User Interfaces
      17″ 1280 x 1024 SXGA TFT display with resistive touch screen
    • Power Supplies
      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, 1x Ethernet port
    • Audit Compliance
      Machine can be used as part of a 21 CFR Part 11 system
    • Machine Dimensions
      810mm (L) x 746mm (W) x 810mm (H)
    • Machine Weight
      125kg
    • Shipping Weight
      225kg
    • Warranty
      Supplied with a 12-month warranty. (Extended warranties are available for additional support).
  • Force Decay

    How does Force Decay testing work?

    An induction sealed bottle is placed into a nest which comprises of a strain gauge load cell, which in turn is housed within a vacuum chamber.

    Vacuum is applied to the chamber and under this vacuum the flexible induction seal 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 bottle or induction seal 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 bottle or induction seal lets air escape into the vacuum chamber.
    • If the bottle or induction seal 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 induction seal bottle is not affected or does not burst, a force reaction/restraining plate is used to prevent full expansion.

    See more

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