PPS a/s primary packaging solutions

LEAK TESTING

Sepha has developed an innovative non-destructive testing method and offers a range of deterministic leak testing systems.

Unlike the Blue Dye Methylene destructive testing system, the Sepha leak test is non-destructive which allows for the tested product to be returned to the production line.

A recent stability study to investigate whether VisionScan leak test method compromise the integrity of the blister pack has confirmed the method truly is non-destructive. Press the button to download the full study.

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Sepha VisionScan

By combining camera imaging technology with differential pressure, the tool-less blister leak test device can detect leaks in individual blister pockets as low as 7 μm. The VisionScan is simple to operate and requires no tooling. It can test multiple packs in various material and design formats.

  • Ideal for high volume production, where high levels of quality control, cost reduction and multiple product changes are required.
  • Accurate, validated results for each blister pocket.
  • Can be part of a 21CFR part 11 compliant system.

Sepha VisionScan Max

The VisionScan Max is a non-destructive, automated and tool-less leak detecting machine for blister packs. For minimal operator involvement, the machine is installed with an automated feed magazine. The leak testing machine has the ability to automatically leak test full production batches at speeds up to 8 packs per minute.

  • Stand-alone at line unit with magazine feed.
  • Capable of detecting defects in individual blister pockets, channel leaks and weak seals down to 7μm.
  • Can be part of a 21CFR part 11 compliant system.

Sepha PakScan

PakScan is non-destructive leak test machines for dry products packed in pouches, sachets, MAP and other non-porous flexible packaging, including PVC, PVDC, Alu/Alu and Aclar. By using force decay technology, the PakScan can detect weak seals and holes down to 10µm.

  • Capable of handling dry, non-porous packages up to 275mm x 90mm x 45mm.
  • Easy to use and fast product change-over.
  • System can be run in compliance with 21 CFR Part 11.

Sepha MediScan

The non-destructive leak detection device, MediScan, is developed to leak test non-porous pouches, sachets and medical device packaging. The machine is tool-less and offers easy operation and fast change-over.

  • Weak seals, channel leaks and holes down to 10μm can be detected.
  • Capable of handling packages up to 100mm x 200mm x 250mm.
  • Audit data available and fully 21 CFR Part 11 compliant.

Sepha BottleScan

The BottleScan is designed for leak testing induction-sealed pharmaceutical bottles. The machine can test up to four bottles per test cycle in 30-90 seconds and is able to detect defects in bottles and inductions seals down to 15µm. It can handle different bottle sizes, making it ideal for production lines with multiple products.

  • The tool-less design allows for fast change-over time.
  • By integrating force decay technology, the system offers a technologically superior Quality Assurance / Quality Control check as part of cGMP.
  • The system is 21CFR part 11 compliant.

Sepha Multi-Q

The Multi-Q is a multi-functional, non-destructive leak detection system for rigid and flexible packaging. The standalone leak test device can be used in combination with interchangeable test attachments to leak test vials, ampoules, pre-filled syringes and bags.

  • Vacuum decay is used to identify leaks and channel leaks as low as 5µm.
  • The Multi-Q can be used to test packages that contain tablets, capsules, devices, or powders.
  • Non-destructive, deterministic, quantitative test method.

LEAK TESTING

Sepha has developed an innovative non-destructive testing method and offers a range of deterministic leak testing systems.

Unlike the Blue Dye Methylene destructive testing system, the Sepha leak test is non-destructive which allows for the tested product to be returned to the production line.

Sepha VisionScan

By combining camera imaging technology with differential pressure, the tool-less blister leak test device can detect leaks in individual blister pockets as low as 7 μm. The VisionScan is simple to operate and requires no tooling. It can test multiple packs in various material and design formats.

  • Ideal for high volume production, where high levels of quality control, cost reduction and multiple product changes are required.
  • Accurate, validated results for each blister pocket.
  • Can be part of a 21CFR part 11 compliant system.

Sepha VisionScan Max

The leak test machine is a non-destructive, automated and tool-less leak detecting machine for blister packs. For minimal operator involvement, the machine is installed with an automated feed magazine. The VisionScan Max has the ability to automatically leak test full production batches at speeds up to 8 packs per minute.

  • Stand-alone at line unit with magazine feed.
  • Capable of detecting defects in individual blister pockets, channel leaks and weak seals down to 7μm.
  • Can be part of a 21CFR part 11 compliant system.

Sepha PakScan

PakScan is non-destructive leak test machines for dry products packed in pouches, sachets, MAP and other non-porous flexible packaging, including PVC, PVDC, Alu/Alu and Aclar. By using force decay technology, the PakScan can detect weak seals and holes down to 10µm.

  • Capable of handling dry, non-porous packages up to 275mm x 90mm x 45mm.
  • Easy to use and fast product change-over.
  • System can be run in compliance with 21 CFR Part 11.

Sepha MediScan

The non-destructive leak detection device, MediScan, is developed to leak test non-porous pouches, sachets and medical device packaging. The machine is tool-less and offers easy operation and fast change-over.

  • Weak seals, channel leaks and holes down to 10μm can be detected.
  • Capable of handling packages up to 100mm x 200mm x 250mm.
  • Audit data available and fully 21 CFR Part 11 compliant.

Sepha BottleScan

The BottleScan is designed for leak testing induction-sealed pharmaceutical bottles. The machine can test up to four bottles per test cycle in 30-90 seconds and is able to detect defects in bottles and inductions seals down to 15µm. It can handle different bottle sizes, making it ideal for production lines with multiple products.

  • The tool-less design allows for fast change-over time.
  • By integrating force decay technology, the system offers a technologically superior Quality Assurance / Quality Control check as part of cGMP.
  • The system is 21CFR part 11 compliant.

Sepha Multi-Q

The Multi-Q is a multi-functional, non-destructive leak detection system for rigid and flexible packaging. The standalone leak test device can be used in combination with interchangeable test attachments to leak test vials, ampoules, pre-filled syringes and bags.

  • Vacuum decay is used to identify leaks and channel leaks as low as 5µm.
  • The Multi-Q can be used to test packages that contain tablets, capsules, devices, or powders.
  • Non-destructive, deterministic, quantitative test method.