PakScan

PakScan is a non-destructive multi-product leak detection device for pouches, sachets, small medical devices and other flexible packs.

Function

PakScan identifies leaks as small as 10µm in sachets, pouches, bags and MAP containing pharmaceutical and medical devices:

It pinpoints micro holes and weak seals in:

  • Non-porous single cavity packs such as sachets, pouches, bags and MAPs etc in flexible materials such as PVC, PVDC, Alu/Alu and Aclar

  • Packs which contain dry powder or a solid component with a head space inside the packs.

  • Simultaneously tests up to 4 packs measuring up to 275mm x 90mm x 50mm each. PakScan can also be customised for 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

  • Can test up to 4 packs simultaneously as standard (5 & 6 pack options available)

  • Capable of handling dry, non-porous packages up to 275mm x 90mm x 50mm

  • User defined password protection ensuring mutliple operator use
  • Easily validated system

  • Repeatable test with objective pass/fail results
  • Test results can beprinted, export4ed via USB (2x) or integrated into local quality control system via Ethernet cable
  • Active Directory and OPC connectivity availbale on request

Application

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 the Quality Assurance procedures for your packaging line. Objective seal testing ensures the integrity of the packaging process.

Reduce production rejects

Minimise reject pouches and sachets 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 a large volume of faulty packages are produced.

Benefits

Non-destructive test generates less waste and bigger product yield

  • The non-contact 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.

Accurate, validatable results for each pouch or sachet

  • Detects holes down to 10 microns.

  • Automatically stores product-specific data in pre-designated file locations. PakScan verifies the product to be tested before each cycle.

  • Totally objective results as no operator intervention is required

  • Pass or fail criteria can be set to the same micron level as your existing Methylene Blue Dye Test.

  • Result data is stored and can be printed or downloaded to other storage devices for further analysis.

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.

Easy to use

  • No special technical skills required.

  • Touch screen operator interface.

  • 30 second product changeover.

Technical Specification

Pack type
Sachets, pouches, bags and MAPs (flexible, non-porous materials)
Pack Dimensions
275mm x 90mm x 50mm (10.8" x 3.5" x 2") per pack.
(The system can be customised for larger packs.)
Operation
Semi–automatic
Machine construction
All product contact areas are constructed from stainless steel (grade 316) and are cGMP compliant.
Operating speed
Up to 4 cycles per minute
Power supplies
Electrical: 110/230V 1kva Single Phase
Air: 6 Bar
Machine Dimensions
750mm (W)x 920mm (L)x 1740mm (H)
(29.2" x 36.2" x 68.5")
Machine weight
200kg (441 lbs)
Shipping weight
300kg (661lbs)
Tooling changeover
Approx. 3 minutes. A different product nest is required for each pack format.
Measurement ranges
Down to hole size of 10 micron
Configuration options
CD-Rom and DVD drive; ethernet; 2 x USB
User Interfaces
VGA LCD MMI colour wide angle touch screen display with virtual instruments
Software
System can be run in compliance with 21 CFR Part 11
Warranty
PakScan is supplied with a 12 month warranty. After this period we recommend the customer takes out a service agreement.