In the highly regulated manufacturing of products such as vaccines, ophthalmics, oncology drugs and other parenterals, sterility testing as well as the rigorous testing of the manufacturing environment are critical. Microbial Quality Control Labs (QC) in sterile pharmaceutical manufacturers struggle with manual test methods that date back more than a century.
The Growth Direct™ System helps sterile pharmaceutical manufacturers reduce both the time and resources required for sterility testing and environmental monitoring testing. For Sterility, results are available in about 7 days, with positive results starting in hours. The non-destructive test eliminates the need for a re-culture step in the event of a failure.
For environmental monitoring, the self-contained system can be located closer to manufacturing, saving travel time. The technology is designed to handle the high volume of samples common with environmental monitoring testing, reducing the resources required. Automation of reporting of test results to LIMs eliminates keying error that can create costly investigations.
Cut testing time from the traditional 14 days to just 7, eliminate multiple checkpoint reads, report contamination immediately, and release your product with a complete sterility testing audit trail by using the Growth Direct System.
The test replicates the temperature, aerobic and anaerobic conditions of the tradtional sterility test. Samples are loaded into the instrument where they are read automatically every 4 hours. An anaerobic indicator assures an oxygen-free environment for the anerobic portion of the test.
Sterility testing with the Growth Direct System eliminates the wait for test results prior to shipping or continuing production, saving days in the manufacturing process.
Eliminate traveling across the campus and manually counting hundreds of plates per day using the Growth Direct System.
Ensuring that the manufacturing cleanrooms are within acceptable limits requires rigorous testing of the air, surface and personnel in the room. Technicians, particularly those in large campus manufacturing environments, must travel to the manufacturing area, collect samples, and return to the lab for incubation. After a few days, they must read and record counts on each plate. The process is resource intensive, time consuming, and prone to potential errors.
Environmental monitoring with the Growth Direct System reduces travel time and errors, improving resource efficiency.
Learn how the Growth Direct System can reduce time and resource requirements in your Sterile Manufacturing environment, contact us today.