Abstract: OBJECTIVE To evaluate the feasibility of BacTALERT^?3D Microbial Detection System carrying out as an alternative method of sterility test in particular injection. METHODS According to the alternative method validation guiding principle in Appendix of Chinese Pharmacopoeia 2010, collecting three different types of injections to validate the specificity, limit of detection, reproducibility and durability which were experimental researched and statistical compared with the pharmacopoeia method. RESULTS No statistically substantial difference in test result was found between using the BacTALERT^?3D Microbial Detection System and the pharmacopoeia method in testing Potassium Aspartate and Magnesium Aspartate injection. But specificity test results showed that BacTALERT^?3D Detection System did not apply to other two injections. CONCLUSION For a specific product, BacTALERT^?3D Microbial Detection System can be used to the production process control after validation.