Pharmaceutical Applications

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

  • the cost per test is high;
  • the process is labor intensive (requiring significant set-up, monitoring and counting), and,
  • the process is episodic and slow, with results generally not available for two to seven 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.  This can then result in product being thrown out, as well as require that expensive and time-consuming investigations be conducted.

BioVigilant’s IMD instruments may be used within pharmaceutical manufacturing when the following conditions exist:

  • 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, 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 IMD instruments may be used in pharmaceutical manufacturing environments in the following ways:

(I) As Warning Instruments

BioVigilant’s instruments can sample the air continuously or be used for spot checks, giving an indication or alarm when microbes are detected.

(II) As Continuous Monitoring and Trending Instruments

BioVigilant’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 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.
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.
(III) To Verify Remediation Was Successful

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.

(IV) To Train Personnel

Finally, BioVigilant’s instruments can be used by trainers to instruct operators in proper techniques to lessen the likelihood of contamination.

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