Application of the BacT/ALERTR 3D system for sterility testing of injectable products
نویسندگان
چکیده
Sterility testing as described in the pharmacopoeia compendia requires a 14-day incubation period to obtain an analytical result. Alternative methods that could be applied to evaluating product sterility are especially interesting due to the possibility of reducing this incubation period and thus the associated costs. The aims of this study were to evaluate the performance of the BacT/ALERT(R) 3D system in detecting microorganisms in large-volume parenteral solutions that were intentionally contaminated and to compare this system to pharmacopoeia sterility testing using the membrane filtration method. The results indicated that there were no significant differences between the methods regarding the ability to detect microbial contamination; however, detection with the BacT/ALERT(R) 3D system was faster compared to the pharmacopoeia method. Therefore, the BacT/ALERT(R) 3D system is a viable alternative for assessing the sterility of injectable products.
منابع مشابه
Use of the BacT/alert system for rapid detection of microbial contamination in a pilot study using pancreatic islet cell products.
At the Islet Isolation Laboratory of the Scottish National Blood Transfusion Service, manual sterility testing data show that contamination rates are 57.7% for pancreas transport fluid, 4.3% for postpurification islet samples, and 0% for pretransplant islet samples. This pilot study presents the BacT/Alert System as an alternative to manual testing to provide more rapid and sensitive sterility ...
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1 Short Form Paper 2 3 4 Use of the BacT/ALERT® System for Rapid Detection of Microbial 5 Contamination in a Pilot Study using Pancreatic Islet Cell Products 6 7 Running Title: BacT/ALERT® System for Islet Cell Sterility Testing 8 9 Laura Murray1, Neil McGowan2, John Fleming1 and Laura Bailey2,3* 10 11 1 Donation Testing Department, Scottish National Blood Transfusion Service, 25 Shelley Road, ...
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