Abstract
Sterility testing as described in the European pharmacopoeia chapter 2.6.1 as well as the United States Pharmacopoeia chapter 71 requires a 14-day incubation period of the test product in two different media and at two different temperatures. Because of extensive personnel requirements for test performance and quality assurance alternative and partially automated methods for product sterility testing are of interest. The study objective was to evaluate the applicability of the BacT/ALERT® 3D™ Dual T system (Biomérieux, Nürtingen, Germany) for detection of microbial contaminants according to current pharmacopoeia standards. In addition, we compared the BacT/ALERT® 3D™ Dual T system to conventional pharmacopoeia sterility testing using the direct inoculation method. The results showed no significant disadvantages of sterility testing by BacT/ALERT® 3D™ Dual T compared to the direct inoculation method regarding the ability to detect microbial contamination. Furthermore product testing using the BacT/ALERT® 3D™ Dual T system met the compendia requirements for method qualification. Altogether, our data provides evidence, that the BacT/ALERT® 3D™ Dual T system is a promising alternative for sterility testing of injectable products of sample volume below 10ml and without antimicrobial activity.
- Received January 20, 2016.
- Accepted June 2, 2016.
- Copyright © 2016, Parenteral Drug Association
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