Abstract: OBJECTIVE To evaluate feasibility of that VersaTrek^® rapid microbial detection system based on respiratory signal detection technology, as an alternative to pharmacopoeia, it can be used for sterility test of cell therapy products. METHODS CAR-T cells were involved to investigate whether the compendial method could be replaced with the rapid method by testing the specificity, limit of detection, repeatability and ruggedness of methods refering to the Chinese Pharmacopoeia 2015 General Chapter 9201 and other foreign guidelines. RESULTS The validation results of each parameter indicate that the rapid method was not inferior to the compendial method. CONCLUSION Under the premise of validation, the VersaTrek^® system can be used as an alternative method to compendia sterility testing for rapid release of specific cell products.