Validation of the BacT/ALERT 3D System for Sterility Testing 18F-FDG

Conclusions: The BacT/ALERT®3D Dual T System was successfully validated for sterility testing of 18F-FDG at BC Cancer. The system demonstrated a higher degree of specificity, repeatability, intermediate precision and robustness. The system also exhibits a superior limit-of-detection as compared to USP<71>. The system is ideal for radiopharmaceutical manufacturers looking to perform in-house sterility testing where traditional microbiology infrastructure is not available.
Source: Journal of Nuclear Medicine - Category: Nuclear Medicine Authors: Tags: Tech Papers III: Radiopharmaceutical Science, Biology & amp; Dosimetry and Professional Practices amp; Education Source Type: research