Merck has launched its sterility testing service for a direct inoculation method using the BACT/Alert® 3D Rapid Microbial Detection System. This new current Good Manufacturing Practice service is suitable for sterility testing of a wide range of sample types including but not limited to cell culture media, vaccines, cell therapies and mammalian cell cultures.
Tests for the presence or absence of viable contaminating microorganisms should be conducted at various stages throughout the manufacturing process as part of an overall microbial control testing program. All preparations and substances that are intended for parenteral administration must undergo sterility testing prior to treatment of patients. While traditional sterility testing methods may take up to three weeks to perform and obtain results, most cell and gene therapy products must be manufactured and administered to the patient within a matter of days due to their short shelf life.
With Merck’s new rapid sterility testing service, results are provided in 11 days with an option for an interim 3-day read, cutting delivery time nearly in half in comparison to traditional methods. The sensors in the sample broth bottles are automatically scanned every ten minutes and will change color when they detect CO2, an indicator of microbial growth.
The presence of turbidity caused by debris or cellular materials does not interfere with the interpretation of results as is often the case with visual examination in more traditional methods. In addition, the non-destructive technology allows for isolation of the contaminant in order to send it for sequence identification.
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