Sterility Testing of Injectable Products: Evaluation of the Growth-based BacT/ALERT® 3D™ Dual T Culture System.

Abstract

Sterility is defined as the freedom from the presence of viable microorganisms. Injectable pharmaceutical products that are sometimes used for treatment of patients need to be free of microorganisms and therefore tested in the laboratory to confirm sterility. The testing procedures are described in detail in the European Pharmacopoeia. To test for sterility, the products need to be incubated for 14 days at two different temperatures and using two different growth media to ensure growth of various microorganisms. These tests, however, are cost- and labor-intensive. Therefore, we sought to use an automated system to reduce costs and hands-on time, as well as to improve quality assurance. The study objective was to evaluate the applicability of the automated BacT/ALERT® 3D™ Dual T system (Biomérieux, Nürtingen, Germany) for detection of microorganisms according to current pharmacopeia standards. We compared the BacT/ALERT® 3D™ Dual T system to standard sterility testing using the so-called direct inoculation method. The results showed no major disadvantages of sterility testing by the automated system compared to the standard method with regard to the detection level of microorganisms. Furthermore, product testing using the BacT/ALERT® 3D™ Dual T system met the compendia requirements for method qualification. Additionally, the new automated method provided reliable results and promises a higher robustness to human errors than do standard manual methods, which might reduce the potential for errors and improves quality assurance. Altogether, our data provide evidence that the BacT/ALERT® 3D™ Dual T system is a promising alternative for sterility testing of injectable products.