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FDA Compliance

Maintaining Quality Assurance in Pharmaceutical Packaging

Easy, reliable leak testing with methylene blue

Published: Tuesday, November 15, 2022 - 12:01

(Wittgas: Witten, Germany) -- Because leaky pharmaceutical packaging can endanger the shelf life and efficacy of packaged medicines, leak testing is a must. This can be easily and reliably done using Witt’s methylene blue test with the Leak-Master Easy.

As particularly sensitive products, medicines require high-quality packaging. Even the smallest leaks, invisible to the naked eye, can render the protective barrier of blister packs ineffective. Oxygen, moisture, and microorganisms can penetrate and make the medicines unusable.

To test the integrity and tightness of blister packs in particular, the packs are placed in a container with an ethanol-based test liquid containing methylene blue as a dye. The blue dye creeps into leaking packages and colors the contents a striking blue, making defective seals or blister cavities clearly identifiable. The method is suitable for detecting leaks with a size of about 10–20 µm.

Witt’s Leak-Master Easy makes the proven methylene blue test particularly fast, reliable, and user-friendly: A vacuum is pulled above the water in the test chamber. The negative pressure first extracts the existing gas volume from leaking blisters. As soon as the negative pressure in the test chamber is equalized again, a negative pressure prevails in the leaking blister, and methylene blue liquid is drawn in, quickly making leakage visible.

The Leak-Master Easy is also low-maintenance with minimal operating costs. Depending on the version, the vacuum can be generated by compressed air or by an electric vacuum pump. Due to the intuitive operation, no specially trained personnel is required. The robust acrylic housing is hygienic and easy to clean; test liquid can simply be drained through a valve at the base.

With the optional Plus control unit, testing is even easier and more standardized. The tester places the product in the chamber and starts a stored test program. The required vacuum is pulled automatically and maintained for the desired test duration. All tests are digitally documented, and the results can be exported.

The Leak-Master Easy is available in seven different chamber sizes. For more information, visit wittgas.com.


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