WuXi AppTec offers rapid sterility testing
WuXi AppTec, a global pharma, biotech and medical device r&d outsourcing company with operations in China and the US, has introduced rapid sterility testing for manufacturers seeking to optimise microbial testing of products with very short shelf-lives where conventional sterility testing methods may be too limited and time-consuming.
WuXi AppTec, a global pharma, biotech and medical device r&d outsourcing company with operations in China and the US, has introduced rapid sterility testing for manufacturers seeking to optimise microbial testing of products with very short shelf-lives where conventional sterility testing methods may be too limited and time-consuming.
For rapid detection, the company can offer the BacT/ALERT 3D microbial detection system. WuXi AppTec will help its customers with the development of sample validation plans to be submitted for regulatory approval. Once this is in place, sterility testing turnround times can be significantly reduced, the company says.
The BacT/ALERT system uses prefabricated bottles of media for both aerobic and anaerobic growth. After sample have been injected into the bottles and incubated, the system monitors them at 10-minute intervals. If micro-organisms are present, the carbon dioxide produced will cause a colour change in the media bottle’s sensor. The change is detected b y a specialised LED in the system and reported to a central computer.
As the detection of microbial growth is based on the production of CO2 rather than visual turbidity as in conventional methods, there is no need for extended incubation to measure sample matrix interference.
