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Sepha - Model MediScan -Non-Destructive Leak Detection Device for Medical Packaging
The Sepha MediScan is a tool-less, non-destructive leak detection device for non-porous pouches, sachets and medical device packaging.
The Sepha MediScan is a package leak test device developed to leak test flexible packaging. The machine is a tool-less, non-destructive leak detection device for non-porous pouches, sachets and medical device packaging.
- Pouches
- Sachets
- Medical device packaging
The machine incorporates leak detection technology and software, developed by Sepha, that is utilized on a daily basis by top global pharma companies to leak test flexible packaging and ensure product packaging integrity.
- Non-destructive seal integrity and leak detection device
- No tooling required, making it highly flexible across several pack types and sizes
- Capable of detecting weak seals, channel leaks and holes down to 10μm (pack dependent)
- Table top device
- Capable of handling 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.
- Active Directory and OPC connectivity available on request
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.
- 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.
- Detects holes down to 10 microns.
- 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.
- 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.
- No special technical skills required.
- Touch screen operator interface.
- 30 second product changeover.
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")
Operating speed
Up to 2 cycles per minute
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.