In the highly regulated manufacturing of sterile products such as vaccines, ophthalmics, oncology drugs, and other parenterals, environmental monitoring, water testing, bioburden testing, and sterility testing are critical.
As sterile pharmaceutical manufacturers face an ever-increasing demand for higher volume and greater speed, relying on the manual compendial testing method isn’t a viable option. It is labor-intensive, slow to produce results, prone to human error, and vulnerable to tampering and poor compliance.
Growth Direct™ is the first and only growth-based system to automate compendial testing. So it helps sterile pharmaceutical manufacturers achieve consistently reliable results in about half the time, reduce errors and investigations, use personnel more efficiently, and bring products to market faster than ever before possible.
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. Because Growth Direct can be placed close to manufacturing, it eliminates travel time and the need to manually count hundreds of plates per day.
Growth Direct is designed to handle the high volume of samples common with environmental monitoring, reducing the resources required.
Plus, Growth Direct automatically reports test results to your laboratory information management system (LIMS), eliminating keying errors that can create costly investigations.
Water testing involves highly trained analysts performing the repetitive, time-consuming task of data collection and collation, for which they may be overqualified.
Growth Direct automates the incubation, reading, and recording of water testing sample results. It can be linked to a two-way laboratory information management system (LIMS) to upload sample work lists and download results.
The result: Growth Direct greatly reduces the time required of analysts, freeing them to do other essential work.
In addition to reducing workload, Growth Direct yields faster results. Typically, results can be obtained in 96 hours rather than the 7 days used in the traditional in-house method. For faster-growing organisms, a positive result can be seen in as little as 20 hours.
In traditional bioburden testing, samples are prepared, incubated for 3-7 days, and then colonies are enumerated and recorded. During this time, products may be stored—or even shipped at risk—while waiting for test results.
Growth Direct streamlines the testing process to deliver positive results starting within hours and final results in about half the time of the traditional bioburden test.