In the highly regulated manufacturing of non-sterile products such as capsules and oral-dose medications, water testing, bioburden testing, and environmental monitoring are critical.
Microbial quality control (QC) labs in non-sterile pharmaceutical manufacturing facilities struggle with the century-old manual compendial test method, which 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 non-sterile pharmaceutical manufacturers reduce both the time and resources required for bioburden testing.
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 manufactured 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. And ensures that the bioburden level is acceptable before products can be released.
Plus, the system automatically and accurately counts and reports test results to your laboratory information management system (LIMS), eliminating keying errors that can create costly investigations.