New PakScan - Non-destructive Seal Integrity Tester

 

Non-destructive Seal Integrity Tester

The new and improved Sepha PakScan is a non-destructive seal integrity tester developed to verify package integrity of flexible packaging. The machine can identify gross holes, leaks and weak seals down to 10µm. Packaging leak testing is essential to ensure package integrity as any defects can affect product quality and shelf life.

 

Non-destructive package leak testingSepha PakScan Close Up - Test Screen

Unlike destructive methods including the bubble leak test and dye penetration test, the Sepha PakScan is a non-destructive test. Utilizing force decay under vacuum, the machine enables customers to perform a dry and clean test on non-porous flexible packaging including pouches, sachets, bags and stick packs containing dry powder or solid components/medical devices. Packs that have passed the test can be returned to the production line, reducing waste and associated cost.


Quick and deterministic results

Depending on pack size and material, the Sepha PakScan can identify holes down to 10µm in up to 10 packs simultaneously, within 30 seconds. The seal integrity tester is easy to operate and eliminates operator subjectivity as the method provides deterministic, quantitative and repeatable results. The result screen shows a visual representation indicating a pass or fail result for each individual packet.

Sepha PakScan Pass Fail result

PakScan test screen shows 1 red fail and 3 green pass results

21 CFR Part 11 Compliant

The machine includes software developed for manufacturers that need to comply with FDA 21 CFR Part 11. The software enables safe interaction between the machine, data reports and audit trails, protecting reports from being edited or deleted.

 

Pack Materials

The Sepha PakScan is suitable to test flexible packaging made from non-porous materials including PVC, PVDC, Aclar and Aluminium foils and laminates that are heat sealed, platen sealed, or flow wrap crimped sealed. The porous and breathable character of Tyvek makes it difficult to pull a vacuum, making it unsuitable for this method of testing in most cases.

 

Pack Dimensions

The system offers a range of standard configurations to include 3, 4, 5, 6, 8 or 10 packs to accommodate different pack sizes ranging from small foil packets to large PVC bags. The technology can be adapted to suit specific requirements and many of our projects include customized solutions to hold larger packs.

 

Configuration Length (mm) Width (mm) Thickness (mm)
3 Packs 270 155 45
4 Packs 270 95 45
5 Packs 270 95 45
6 Packs 130 155 45
8 Packs 130 95 45
10 Packs 130 95 45

Table: Standard pack dimensions

MES Connection

If you have implemented a Manufacturing Execution System, the PakScan can be easily linked via its MES connector. This enables you to control production, monitor and analyse processes, and document data and activities to increase efficiencies.

 

Still using destructive methods?

Many manufacturing companies are looking for alternative seal integrity test methods that can reduce cost and have less environmental impact in terms of waste (lost product, lost material and disposal cost). If you are interested to make the switch to a non-destructive method or you have any queries regarding the material or size of one of your projects, get in touch using the button below.

Get in Touch

 

New PakScan video

 

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About the Author

The Sepha blog is an information source for all professionals in the pharmaceutical and medical device industries. It provides in-depth articles and the latest trends and developments in leak testing, deblistering and blister packaging.

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