Evaluation of BACTECTM FX Blood Culture System for Rapid Sterility Testing of Human Medicinal Solutions for Infusion

Abstract

Human medicinal products for infusion should be tested for sterility at various stages of manufacturing including the final step before marketing. Conventional sterility methods recommended in pharmacopeia need a 14 days incubation period in order to get reliable analytical results. However, rapid alternative methods based on automated detection of microbial growth have the advantage of taking only 5 days for sterility testing of medicinal products which can be very important especially during pandemics and emergency conditions. The aim of the present study is to evaluate the microbial detection potential and capacity of the BACTEC FX system for the rapid sterility testing of Paracerol, a 10 mg/mL paracetamol containing pediatric medicine for infusion, and to specify time required for the detection of a variety of microorganisms. Accordingly, the results showed that there were no significant differences between the BACTEC and conventional membrane filtration methods for detecting contamination. All positive/negative controls and all samples intentionally contaminated with microorganisms were determined correctly by using both methods. BACTEC FX system detected all microorganisms including slow growers significantly faster than the membrane filtration method (p<0.05). This system can be considered as a rapid alternative over conventional sterility methods for the release of human medicinal products for infusion to the markets especially under emergency conditions. However, for each particular products, validation steps should be executed according to European Pharmacopoeia by using a broad range of microorganisms.