Objective      To establish a rapid and sensitive sterility test method

so as to overcome the limitations of long detection cycle (generally 14-21 d)

low sensitivity

low degree of automation

and prone misjudgement in conventional sterility test.       Methods      Microcalorimetry was adopted to establish a novel sterility test and compare with the conventional sterility test. Methodology investigation was carried out to ascertain the sensitivity of microcalorimetric sterility test. The discrimination capability of the microcalorimetric sterility test to the norm-sterilized samples (Norm-SS)

non-sterilized samples (Non-SS) and sub-sterilized samples (Sub-SS) of Fufang Yinchen injections was further investigated.       Results      The results showed that microcalorimetric sterility test could detect out the positive indicator bacteria such as Staphylococcus aureus (S. aureus)

Escherichia coli (E. coli)

Pseudomonas aeruginosa (P. aeruginosa)

Bacillus subtilis (B. subtilis)

Clostridium sporogenes (C. sporogenes)

Candida albicans (C. albicans) and Aspergillus niger (A. niger) within 10 h with the detection limitation of 100 cfu

and could distinguish the Non-SS and Sub-SS from Norm-SS accurately

rapidly and sensitively.       Conclusion      The microcalorimetric sterility test method is more sensitive

rapid and sensitive than the conventional culture medium turbidity observation method

and automatic online monitoring is possible.