Rapid Microbiological Methods in the Era of Validations

Any new technique or equipment needs to be validated prior to entering its use in the commercial arena. The validation assures equivalency of the new method to the reference method. This means that the new technique or device is giving us “real results” that are reproducible and that can be trusted. USP <1223> Validation of alternative microbiological methods and ISO 16140 defines the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis In the industrial world there is a pressing demand for rapid microbial detection technologies in order to improve the quality of products and their safety and speed up time to results. Their benefit could include significant reductions in time-to-result over conventional methods, improved sensitivity, specificity and accuracy, benefits of automation, reduced requirements for staff training, rapid product release, and lower inventory.

There are several new rising technologies that provide rapid microbial detection; such as the exceptional one developed by BioLumix. However, to be broadly used and accepted these new technologies need to comply with USP standards and fulfill the validation process. In order to get the validation assurances a series of pre-established analyses need to be done and compared the data generated by the new technology with the USP data to show equivalence. How valid the classical analyses are, it is a matter of historical use and common acceptance.

There are three required qualification components in a validation package; these are: installation, operation, and performance qualifications. The assurances for installation and operation qualifications deal with how reliable the setting and handling are; and that the proper conditions are given for the device or technique to work properly. To ascertain the reliability of performance qualification intuitively important are the internal positive and negative controls and well-known standards. Controls are the building blocks of any scientific approach to test hypotheses and to answer specific questions accurately. The controls and standards contain known amounts of the substance tested by the new technology. Under good laboratory practices isolated microbes are used in the manufacture of these controls and standards. Controls and standards are then used to validate the detection and quantification of unknown samples by the specific technique or device. In addition, controls and standards allow the validation of various important performance criteria, such as: accuracy and precision, specificity, and range, limits of detection and quantification, along with ruggedness and robustness. Accuracy is how close the results to the true value are. The precision deals with the agreement among individual tests. Specificity is given when detection of a particular microbe occurs even in a mix of different microbes without cross detections. The range is the upper and lower microbial count level limit that gives precise and accurate measurements. Limit of detection are the lowest microbial counts that can be detected. Ruggedness is related with the reproducibility of the results considering different equipment, personnel, laboratories, etc. And robustness indicates the capacity of the device or technique to absorb small variations such as: incubation conditions, media brands, reagents quality, etc.

The validated BioLumix system is an alternative to the classic USP methodology, which is highly time consuming and requires trained technical personnel. Using the BioLumix system, in just 48 hours a certificate of analysis is generated from samples that do not require special handling neither sophisticated processing. Hence, one of the best advantages of the BioLumix system is that does not require highly skilled personnel. BioLumix system ought to be used by a wide variety of manufacturing industries, which need to accurately certify the microbiologic status of their products in order to ensure their safety. Remarkably, the BioLumix system is capable of detecting a wide variety of microbes that raise health concerns such as: E. coli, Salmonella, Staphylococcus, yeast and molds, etc. BioLumix is committed to fulfilling the high demand for saving industries money and time in this fast pacing era of assurances and validations.