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AssigneeCornell Research Foundation, Inc.
InventorKarl J. Siebert
Estimating the term…
The present invention features a method of using a computer program to simulate the process of randomly selecting sample packages from a large lot of a fluid comestible or pharmaceutical, and examining a portion of the package contents for microorganisms in order to assess the risk of bacterial contamination. The computer program is used to evaluate the theoretical effects on results, such as mean, standard deviation and detection or non-detection of bacteria for various sampling choices for a particular number of samples selected from a production lot. The sampling pattern can be varied, in order to provide results related to small or large numbers of packages, with small or large volumes sampled from each. The theoretical behavior of particular organisms can be simulated in the program by applying a growth, death or stasis factor. This factor can be chosen by the practitioner based on previous testing and analyses. After completing a number of simulations and assessing the results, these results can be compared to results from actual tests. The test methodology for the particular product can then be improved by incorporating the suggested sampling procedures obtained through this comparison. Future testing can then be performed to confirm the results; still further modifications can be made of the test procedure, based on these additional tests.
A method of simulating a process of randomly selecting sample packages from a large lot of a fluid, and examining a portion of each selected sample package for microorganisms, and thereafter comparing the simulated process with a prior test procedure to determine a better test procedure for assessing a risk of contamination in said fluid, the method comprising the steps of:
A method of simulating a process of randomly selecting sample packages from a large lot of a fluid, and examining a portion of each selected sample package for microorganisms, and thereafter comparing the simulated process with a prior test procedure to determine a better test procedure for assessing a risk of contamination in said fluid, the method comprising the steps of:
A method of testing a fluid for microorganisms by a simulated process of randomly selecting simulated sample packages from a large lot of said fluid, generating a Poisson distribution for organisms in said simulated sample packages, examining a portion of each selected simulated sample package for microorganisms and generating a statistical report, performing actual fluid tests based on said simulated process, including a measurement of microorganisms in said fluid, and thereafter comparing said actual fluid tests performed, using the simulated process and a prior test procedure to determine a better test procedure for assessing the risk of contamination in said fluid.
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