Reduce integrity test time without losing accuracy and reliability
--Sartocheck® 4 plus solution
Background introduction
Integrity testing of sterilizing filters is a critical step in the biopharmaceutical manufacturing process and is subject to mandatory regulation. It takes a long time for pharmaceutical companies to successfully complete the integrity testing of such filters. For example, it takes 20 to 30 minutes to complete integrity tests such as diffusion flow, bubble point, and water intrusion. In fact, as long as the method is right, pharmaceutical companies can ensure the accuracy and reliability of the integrity test results in production practice, and can effectively shorten the test time. In this regard, this article describes several efficient and workable methods to reduce the integrity test time. With the Sartocheck®4 plus integrity test solution, you can save up to 90% integrity test time.
Factors that determine test time
The integrity test consists of several different test phases and, in general, can be divided into a stable phase and a test phase. As the name implies, the role of the stabilization phase is to provide stable test conditions for integrity testing, which is critical to the accuracy and reliability of integrity test results. Specifically, during the initial pressurization phase of the integrity test, for example, the tester is pressurized to the test pressure set by the system at 2500 mbar, and undergoes a thermodynamic process: the filter case with the built-in filter element is filled with test gas ( The process of compressing air, etc.) is the process of an energy input test system. The energy input to the test system can be directly quantified by measuring the temperature rise value. After pressurization, the temperature will drop again, or temperature compensation will occur between the filter housing and the environment. This is because the filter housing of the filter is filled with the test gas and the volume remains constant, so that when the temperature is lowered, the pressure inside the filter housing of the filter is correspondingly lowered (pV = nRT). In addition, the integrity tester cannot tell if the pressure drop of the system under test is caused by diffusion or due to temperature fluctuations. Therefore, shortening the integrity test stability phase time always leads to the risk of instability of the integrity test, which ultimately threatens the accuracy and reliability of the integrity test results. In summary, we basically do not recommend to shorten the time of the integrity test stability phase simply to save time.
The subsequent test phase makes it easier to achieve constant test conditions relative to the stabilization phase of the integrity test. This means that there are many possibilities to shorten the test time during the testing phase.
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