{"id":6280,"date":"2021-05-26T09:18:54","date_gmt":"2021-05-26T09:18:54","guid":{"rendered":"https:\/\/www.acrn.fr\/product\/cte-bi"},"modified":"2026-05-19T16:38:31","modified_gmt":"2026-05-19T14:38:31","slug":"methylene-blue-leak-tester","status":"publish","type":"product","link":"https:\/\/www.acrn.fr\/en\/product\/methylene-blue-leak-tester\/","title":{"rendered":"CTE-Bi Leak test box"},"content":{"rendered":"

CTE-Bi in the pharmaceutical industry<\/span><\/strong><\/h3>\n

In the pharmaceutical industry, the integrity of primary packaging is a non-negotiable regulatory requirement. A punctured blister pack, a poorly sealed pouch, or an inadequately heat-sealed lid can lead to contamination of the medication, a loss of sterility, or a change in the product\u2019s properties, with direct consequences for patient safety.
\nThe methylene blue test is one of the most widely used integrity testing methods in pharmaceutical plants for blister packaging (tablets, capsules, blister packs), as it directly meets the requirements of European and U.S. (FDA 21 CFR) GMP (Good Manufacturing Practices) guidelines. Its visual, non-instrumental, and unambiguous nature makes it a method that can be easily validated and documented within pharmaceutical quality systems.
\nThe CTE-Bi\u2019s built-in scale ensures consistent sample positioning from one test to the next, a critical factor for the repeatability and reproducibility required in method validation protocols (IQ, OQ, PQ). The removable drip tray makes it easy to collect samples after testing, minimizing contamination of the work area by the dye.<\/p>\n

Methylene blue test vs. water immersion test<\/span><\/strong><\/h3>\n

Both the CTE-Bi and the CTE-I are based on the same principle of creating a vacuum in a chamber, but differ in the test fluid used and their scope of application:
\nThe water immersion test (CTE-I) allows the leak to be visually located by the appearance of bubbles during the vacuum test. It is suitable for air-filled packaging, food pouches, doypacks, and flexible packaging in general.
\nThe methylene blue test (CTE-Bi) detects leaks after the package is returned to atmospheric pressure, as the dye seeps into the packaging. It is specifically designed for pharmaceutical blister packs, where detection during vacuuming is difficult, and where evidence of contamination by the dye provides an indisputable binary result (pass\/fail) that can be directly incorporated into batch records.<\/p>\n

Benefits<\/span><\/strong><\/h3>\n