Validation of a Rapid Microbiological Method for the Detection and Quantification of the Burkholderia cepacia Complex in an Antacid Oral Suspension

Abstract

Background Despite the broad adoption of Soleris® technology in the food industry as semiquantitative method, they are almost completely unexplored in the pharmaceutical industry as a quantitative method for quantification of Burkholderia cepacia complex. Objective The efficacy of an automated growth-based system for a quantitative determination of the Burkholderia cepacia complex in an antacid oral suspension was studied. The main purpose of this validation study was to prove that the alternative method’s entire performance is not inferior to the conventional method for a quantitative determination of Burkholderia cepacia complex. Methods The antacid oral suspension’s preservatives were neutralized, leading to the Burkholderia complex’s recovery by means of the alternative method and the reference method. A calibration curve was generated for each strain by plotting DTs relative to the corresponding log CFU values. An equivalence of results was done through the construction of calibration curves that allowed the establishment of numerically equivalent results between the enumeration data from the reference method and the alternative method. Results Thus following the guidelines of USP, essential validation parameters were shown, such as equivalence of results (CC > 0.95), linearity (R2 >0.9025), accuracy (% recovery >70%), operating range, precision and ruggedness (DS < 5 and CV < 35%), specificity (inclusivity and exclusivity), limit of detection, and limit of quantification. Conclusions It was shown that all the test results obtained from the alternative method were in statistical agreement with the standard method. Thus this new technology was found to meet all the validation criteria needed to be considered to be an alternative method for the quantification of the Burkholderia complex in the antacid oral suspension tested. Highlights mplementation of alternative methods can offer benefits in execution and automation while improving accuracy, sensitivity, and precision and reduce the microbiological process time compared to the traditional ones.