BioLaz®实时微生物监测仪的验证

Abstract

Validation of the BioLaz® Real-Time Microbial Monitor

Pharmaceutical manufacturers are required to prove control over their aseptic manufacturing, which requires monitoring for presence of airborne microbial contamination. Standards for such monitoring are defined by both the United States and the European Pharmacopoeia. Since the 1960’s, presence or absence of microorganisms in the areas of risk in the manufacturing environment have been confirmed using laboratory culture techniques that require hours or days to provide results. Now, Particle Measuring Systems in conjunction with industry partners has developed a new instrument, the BioLaz Real-Time Microbial Monitor, to continuously monitor for presence of airborne microorganisms in real-time, thus providing the fill-line operator the opportunity to stop the filling process instantly instead of waiting for colony growth results from an agar technique. Testing of this new instrument resulted in clear evidence that the BioLaz Real-Time Microbial Monitor meets or exceeds the guidelines established in USP <1223> Validation of Alternative Microbiological Methods and EP 5.1.6. Alternative Methods for Control of Microbiological Quality.

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