Sepha Ltd
Unit 25 Carrowreagh Business Park
Carrowreagh Road, Dundonald
Belfast
BT16 1QQ
Northern Ireland
United Kingdom
Tel: +44 (0)28 9048 4848
Fax: +44 (0)28 9048 0890
Email: info@sepha.com
Contact Us
PakScan
Non-destructive leak testing machine for pharmaceutical sachets and medical pouches
PakScan identifies leaks as small as 10µ 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 MAPs etc in flexible materials such as PVC, PVDC, Alu/Alu, Aclar etc
- 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 250mm x 80mm x 20mm each. PakScan can also be customised for larger packs.
Non-destructive leak tester for pouches and sachets, perfect for:
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.
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. BlisterScan 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.
Machine Operation
1. The operator inserts the custom product nest into the tooling holder.
2. The operator then places the sample pouches into the product nest.
3.The operator closes the lid to seal the test chamber and presses the start button.
4. PakScan runs the test which consists of 4 test phases:
Evacuation Phase: A pre-determined level of vacuum is applied to generate an expansive force which is monitored throughout the test cycle.
Stabilisation Phase: Following evacuation of the vacuum, a stabilisation phase allows the air temperature to normalise.
Decay Test Phase: The decay test phase measures any reduction in head space pressure. If the expansive force decays by more than a set amount the pack will be classed as a failure.
Gross Hole Identification Phase: At the end of the decay phase, if the reactive force is less than the pre-determined level in the test method, a pack will be classed as a gross leak failure.
5. A Pass or Fail result for each pack is shown on the screen immediately after completion of the scan.
Storage of Result Data
A pack format library is installed onto the system before delivery. New formats can be added via any data storage device, eg USB, CD-Rom. All results are stored and can be printed or downloaded to other storage devices
Tooling
A different product nest is required for each different pack to be tested.
Technical Specifications
| Pack Type | Sachets, pouches, bags, MAPs in flexible and non-porous materials |
| Pack Dimensions | 250 x 80 x 20mm 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. Bench top models can be supplied as a customised option. |
| Operating Speed | From 12 cycles per minute |
| Power Supplies | Single phase electricity; 110/230V 1kva |
| Machine Dimensions | 1015W x 776L x 1721H mm |
| Machine Weight | 150kg |
| Shipping Weight | 180kg |
| 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; 2x USB |
| User interfaces hardware | 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. |
Product Brochure
Sepha Blisterpacking, Leak Testing and Deblistering Equipment Brochure (.pdf format - 1175KB)
Useful Articles and Whitepapers about Leak Testing
Comparison of Leak Test Methods
Examines how different types of leak test match up to critical criteria.
Specification for a Leak Tester
Details a typical specification for a leak test and shows how BlisterScan compares.
How to Calculate Leak Testing Savings
Shows how leak testing improves quality control and improves blister packing processes.
FAQs about BlisterScan Non-Destructive Leak Tester
Your questions answered about detecting leaks and weak seals in blsiter packs with Sepha's BlisterScan.
PakScan: Non-destructive leak tester for pharmaceutical pouches and sachets