In the highly regulated manufacturing of medical devices such as pacemakers, vascular grafts, and stents, environmental monitoring, water testing, bioburden testing, and sterility testing are critical.
Microbial quality control (QC) labs in medical device manufacturers struggle with time-consuming, labor-intensive, error-prone manual compendial test methods that date back more than a century.
Growth Direct™ is the first and only growth-based system to automate compendial testing. So it helps medical device 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 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 them to the lab for incubation.
After a few days, the samples must be read and counts on each plate recorded. The process is resource-intensive, time-consuming, and error-prone.
Because Growth Direct can be placed close to manufacturing, it eliminates travel time and the need to manually count hundreds of plates per day.
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 captured, incubated for 3-7 days, then colonies are enumerated and recorded. During this time, products may be waiting for results of the test before being shipped. Accurate recording of colony forming unit (CFU) counts is vital, and a simple keying error could delay product shipment or cause a costly investigation.
With Growth Direct, you reduce testing time, improve efficiency, and avoid manual counting and reporting steps. It improves efficiency by automating and accelerating bioburden testing and eliminates the manual enumeration and reporting steps. Integrating Growth Direct into your laboratory information management system (LIMS) reduces manual errors and increases productivity.