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
BlisterScan
Non-destructive leak testing machine for pharmaceutical blister packs
BlisterScan, the non-destructive leak tester, identifies leaks as small as 7µ in individual blister pockets of pharmaceutical or medical blister packs. It is the perfect alternative to the Methylene Blue Dye Test
It pinpoints micro holes and weak seals in:
- Non-porous blister packs in materials such as PVC, PVDC, ALu/Alu, Aclar etc
- Blisters containing solid dose products such as tablets, capsules or medical devices.
- Multiple blisters from a full sealing index measuring up to 320mm Width x 150mm Length
Non-destructive leak tester for blister packs, 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 blister packaging line. Objective seal testing maintains compliance and ensures the integrity of the packaging process. BlisterScan ensures protection from moisture, air and bacteria and allows investigation of atypical results.
Reduce production rejects
Minimise reject blisters 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 blisters are produced.
Non-destructive test generates less waste and bigger product yield
- The non-contact laser scanning 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 pocket
- Detects holes down to 10 microns.
- Totally objective results as no operator intervention is required
- Pass or fail criteria can be set to the same micron level as your existing 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.
Fast payback by reducing waste
- The average user can save $1,000 per day by replacing the methylene blue dye test with BlisterScan
Easy to use
- No special technical skills required.
- Touch screen operator interface.
- 30 second product changeover.
Leak Test Method
A beam of light scans the individual pockets before and after applying a vacuum. After a set dwell time the blister pockets are scanned again. A Pass or Fail result is given for each individual pocket based on a comparison of the “before” and “after” readings against a pre-determined leakage acceptance level. Further graphical analysis is provided for each individual blister pocket. This enables engineers to trace and identify the source of a leak more easily.
SEPHA is happy to deliver a live web-based demonstration of BlisterScan. Request a demonstration.
Machine Operation
- The operator inserts the custom product nest into the tooling holder and closes the drawer.
- BlisterScan automatically scans the nest and selects the correct test method from its library of pre-programmed blister formats.
- The operator enters batch data via the touch screen and keyboard.
- The operator opens the drawer and places the blister packs in the product nest.
- The operator closes the drawer to seal the test chamber and presses the start button.
- BlisterScan runs the test.
- A Pass or Fail result for each pocket is shown on the screen.
Storage of Result Data
A blister format library is installed onto the system before delivery. New formats can be added via any data storage device, eg USB, CD-Rom.
Tooling
A customised leak test method is developed for each product. Two low-cost product-specific nests are also required, which the system uses to identify the correct test method for that product.
Calibration
BlisterScan is supplied with a calibration tool. Calibration options are selected from the touch screen display.
Product Recognition
Automatically stores product-specific data in pre-designated file locations. BlisterScan verifies the product to be tested before each cycle.
Technical Specifications
| Blister web | Up to 320mm width, up to 150mm length |
| Test cycle time | 1-6 minutes |
| Measurement ranges | Down to hole size of 7 micron |
| Tooling changeover | Approx 30 seconds |
| Configuration options | CD-Rom and DVD drive; ethernet; 2x USB |
| Power supplies | Air: 6 bar; Electrical: 110/230V AC |
| User interfaces hardware | VGA LCD MMI colour wide angle touch screen display with virtual instruments; Integral QWERTY keyboard; printer |
| Software | System is 21 CFR Part 11 compliant |
| Machine construction | are cGMP compliant. |
| Machine dimensions | 630mmW x 770mmL x 1600mmH (25” W x 30” L x 63” H) |
| Machine weight | 125kg (275lbs); shipping weight 300kg (660lbs) |
| Warranty | BlisterScan 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.
BlisterScan: Non-destructive Leak tester for pharmaceutical Blister packs - perfect blue dye test alternative







