Continuous Microbial Monitoring And Trending Instruments

AzbilBioVigilant’s instruments can provide continuous monitoring and trending, functionality not possible using existing conventional methods. In addition to helping to comply with existing regulatory and internal requirements, this unique feature of AzbilBioVigilant’s technology makes its instruments especially suitable for implementation of the FDA’s Process Analytical Technologies (PAT) initiative by providing a process analyzer tool for microbiological monitoring.

In an aseptic manufacturing facility, it is advantageous to be able to observe trending patterns of microbial and particulate distribution so that a microbial incursion can be detected and action taken as soon as possible. AzbilBioVigilant’s IMD instruments are able to obtain the trending from analyses of a continuous stream of data, and thereby spot anomalies.

Additionally, because of the technology used by AzbilBioVigilant’s IMD instruments, samples are not destroyed. As a consequence:

• Ongoing samples may be taken, thereby making the sampling more representative of the entire batch and any contamination that exists more likely to be discovered earlier in the production process; and at certain points in the production process (such as when vials are being filled), continuous sampling of entire batches is a possibility, thereby making it more likely that, if contamination is encountered, a smaller batch of production will have to be discarded.