For both internal and regulatory reasons, within the pharmaceutical manufacturing environment, it is required that testing is done to in order to determine the level of microbial contamination.  Existing conventional testing methods, however, all have several undesirable attributes in common:

• the cost per test is high;
• the process is labor intensive (many times requiring significant set-up, monitoring and counting), and,
• the process is episodic and slow, with results generally not available for two to five days.

Among these undesirable attributes, the consequences of waiting for results are generally the most significant, and include costly planned and unplanned halts in production, as well as continued production under incorrectly assumed to be acceptable conditions and finding out later that, in fact, the conditions were not within regulatory or internal requirements.  This can then result in product being thrown out, as well as make it required that expensive and time-consuming investigations be conducted.

• There is a desire to know the level of microbial contamination.  (Generally, this occurs in places where culturing or “rapid methods” are now employed, as well as in other places.)
• There is value in knowing the results instantaneously, as opposed to waiting, in the best case, for several hours, or more commonly, for several days.

Additional IMD advantages include that there is very little preparation or human intervention required, and IMD can monitor continuously, as opposed to existing methods where tests are performed episodically.

BioVigilant’s IPD and IMD devices can be used in pharmaceutical manufacturing clean rooms in the following ways:

(I) As Warning Instruments

BioVigilant’s detectors can sample the air continuously or do spot checks and give an indication or alarm when microbes are detected. 

(II) As Continuous Monitoring and Trending Instruments

The ability of BioVigilant’s IMD instruments to provide instantaneous microbial detection also enables them to provide continuous monitoring and trending, which is useful functionality not possible using existing conventional methods.  In addition to helping to comply with existing regulatory and internal requirements, this unique feature of BioVigilant’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 of clean room air and liquids.0

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. BioVigilant’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 BioVigilant’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 than would be otherwise.

(III) To Verify If Remediation Was Successful

Finally, BioVigilant’s IMD instruments can be used to obtain immediate results, for example, after remediation of microbial contamination has taken place, to determine, on a real-time basis, if the remediation was successful.

For more detailed information on how BioVigilant’s Instantaneous Microbial Detection instruments can be used for pharmaceutical manufacturing, please read the whitepaper, or contact BioVigilant at (520) 292-2342 or info@BioVigilant.com.