The Growth Direct™ System is designed to automate the incubation, detection, enumeration and reporting steps for environmental monitoring and bioburden applications in pharmaceutical quality control laboratories. The technology is based on the detection of the natural auto-fluorescence of microorganisms; requiring no additional reagents to detect growing colonies. The Growth Direct System can handle both the environmental monitoring and bioburden (in-process and water) applications.
The environmental monitoring application for the Growth Direct System automates the high volume testing typically found in the combination of air, surface and personnel monitoring.
• Delivers efficiency: Automated reading and data transfer to laboratory information management systems (LIMS) frees personnel from tedious handling and counting of hundreds of plates a day allowing resources to focus on higher value activities.
• Audit trail: The system provides a complete, error-free record of all activities and results.
• System can be located near production: On a large site, the Growth Direct System can be located near manufacturing, increasing efficiency and reducing the travel risk with critical samples.
The Bioburden Testing application for the Growth Direct System advances the already validated technology in the area of in-process bioburden and water testing.
• Automated: Tedious, manual steps associated with the assay are eliminated. Users simply prepare the sample and load it into the system. The system automatically handles serial incubations and processes samples 24/7.
• Rapid results: Positive results starting within hours and final results in about half the time of the compendial method.
• Simplified Validation: Because the test is considered “automated compendial”, the validation requirements are lessened, speeding time to value.
