MediScan

MediScan is a tool-less, non-destructive leak detection device for non-porous pouches, sachets and medical device packaging.

Function

MediScan is a tool-less, non-destructive leak detection device that identifies leaks as small as 10μm in non porous:

  • Pouches

  • Sachets

  • Medical device packaging

It incorporates leak detection technology and software (developed by Sepha) and is used daily by leading global pharmaceutical companies to ensure product integrity in their production lines.

Features

  • Non-destructive seal integrity and leak detection device

  • No tooling required, making it highly flexible across a number of pack types and sizes

  • Capable of detecting weak seals, channel leaks and holes down to 10μm*

  • Table top device

  • Capable of handling wet** or dry non-porous packages up to 100mm x 200mm x 250mm

  • Easy operator use via touch screen interface and easy load chamber

  • Capable of storing multiple test methods for up to 30,000 product types

  • User defined password protection ensuring multiple operator use

  • Fully validated system

  • Production of objective and repeatable results

  • Test results can be printed, exported via USB (x2) or integrated into local quality control system via Ethernet cable

  • Fast, efficient test speed

  • Audit data available and fully 21 CFR part 11 compliant.

  • Acitve Directory and OPC connectivity abailable on request

* Pack dependent
** Product dependent

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 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 (e.g. 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 10μm.

  • Automatically stores product-specific data in pre-designated file locations. MediScan 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

Operation
Semi-automatic
Construction
304 Stainless Steel Casework
Pack type
Sachets, pouches, bags, MAPs and flexible packaging (non-porous)
Pack Dimensions
Up to 250mm (L) x 200mm (W) x 100mm (D)
(9.8" x 7.9" x 3.9")
Test Cycle
From 20 seconds
Software
Easy to use operator touchscreen interface
Machine dimensions
700mm (W) x 490mm(L) x 560mm (H) mm
(27.6" x 19.3" x 22")
Machine weight
63kg
Shipping weight
113kg
Approx tooling changeover
No tooling required.