Sepha will be demonstrating its latest leak test solutions for the pharmaceutical industry at CIPM in Chongqing from 5 – 7 November 2019. The Sepha VisionScan and Sepha Multi-Q will be on display on the stand of its agent Rieckermann in Hall S1, location 26.

Leak Test Methods

Manufacturers of pharmaceutical blister packs and containers need to be able to demonstrate package integrity of their products. The packaging needs to protect the product inside to ensure shelf life of the product. The most common technique used to test the integrity of pharmaceutical packaging is methylene blue dye testing. This test relies on subjective inspection of the packs by the operator and are destructive, resulting in excessive and unnecessary waste.

While methylene blue dye testing is in line with approved regulations, new guidelines by USP concentrate more on deterministic and objective methods.

 

Non-destructive Blister Leak Test

The Sepha VisionScan offers a reliable and cost saving alternative to methylene blue dye testing. The tool-less machine is a deterministic and non-destructive leak detection device that can detect micron holes in blister packaging as low as 7 micron in 10 seconds and macro holes in 7 seconds. It uses a combination of imaging technology and differential pressure to detect leaks in individual blister pockets. The flexible and easy to use machine provides a clean and dry testing process, enabling product to be returned to the production line.
Read more about the Sepha VisionScan.

Container Closure Integrity Testing

Sepha Multi-Q CCIT & Leak Test SolutionThe Sepha Multi-Q is the latest innovation that has been added to Sepha’s growing portfolio of specialist Non-destructive Leak Detection solutions for the pharmaceutical industry. The small Container Closure Integrity (CCI) test machine comprises a base unit that can be used in combination with different testing methods and offers an all-in-one solution to test the integrity of all types of containers including sachets, pouches, bags, bottles, vials, ampoules, pre-filled syringes, trays, medical devices and modified atmosphere packaging (MAP).

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 and protects reports from being edited or deleted.

The testing methods compatible with the Sepha Multi-Q include

  • Flexible Membrane 
  • Vacuum Decay
  • Pressure Decay
  • Pressure Decay Bag Tester
  • Ramp to Event
  • Ramp to Proof Pressure
  • Occlusion

These non-destructive and deterministic test methods provide quick, reliable and repeatable results enabling customers to improve the accuracy of their leak detection procedures and reduce cost as the method prevents the packaging from being damaged.
Read more about the Sepha Multi-Q

To see a demo of the machines, visit us at the Rieckermann stand S1 – 26 at CIPM China.

We look forward to seeing you in Chongqing!

 

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