With the continuous improvement of the integrity testing technology, the integrity testing instrument for the filter integrity testing has become more and more important. The integrity tester directly judges the performance of the filter element, and even the personal health of the user. Integrity testing is a necessary tool for critical sterilization-grade filtration processes to ensure the safety of the filtration process. Through integrity testing, the integrity of the filter itself and its correct installation can be determined, the correct filter is installed in the process, the installed filter can be determined to meet the standards provided by the manufacturer, and the airtightness of the filter system can be ensured and many more. At the same time, performing integrity testing is also a requirement of national regulations and audits.
Integrity testing technology can be used to judge whether the filter material has defects and whether the porosity meets the specifications, so it is widely used in pharmaceutical companies, filter material manufacturers and research units. In the pharmaceutical industry, filter integrity testing is a required requirement for filtration processes. The U.S. Food and Drug Administration (FDA) clearly states in Guidelines for the Manufacturing of Sterile Products (2004): "Validation of filtration systems consisting of one or more filters should include microbial challenges under worst-case conditions. Trials and integrity testing."
my country's Good Manufacturing Practice for Drugs (2010), Appendix 1 "Sterile Drugs" stipulates: "After the sterilizing filter is used, its integrity must be checked and recorded immediately by appropriate methods. The commonly used method is the bubble point test. , diffusion flow test or pressure hold test."