BIOTECHNOLOGY 73
comparable results in half the time of the traditional test, a significant time saving.
An example of this technology is the Growth Direct system for sterility testing. It is designed to mirror the traditional sterility incubation regimen to cover the three existing conditions in the traditional sterility cassette, 2 aerobic and 1 anaerobic to provide testing at both 20-25°C and 30-35°C.
Like the traditional test, samples are filtered using on-market sterility pumps through a standard mixed ester membrane to capture the micro-organisms. Once captured, media is added and the samples loaded into the automated technology. Within the Growth Direct system, advanced robotics manage the incubation and colony detection process, reading samples every few hours and analysing the results to determine if there is growth.
Automated, non-destructive rapid methods such as this detect microcolonies of around 100 cells, rather than the 5x106
cells
forming a colony that a human eye may see.
For this reason bacterial growth can be detected faster than a manual test and therefore a negative test can be recorded in around half the time of the traditional test, making the sterility test take 7 days rather than the traditional 14.
In addition, traditionally turbid samples are not an issue after filtration, meaning that the 18-21 days required using the traditional method is not required and the test will still only take 7 days. Initial detection of growing colonies can occur in the first few hours. Tis significant reduction in time to results can have a measurable impact in a manufacturer’s ability to ship high quality product more rapidly, or potentially
respond faster to pandemics with vaccines.
Sterility testing is a time- consuming process that must be performed. Automated technologies such as the Growth Direct system can provide a solution that provides a comparable result in about half the time and reduces resource requirements, providing a faster non-destructive test with more traceable results.
For more information ✔ at
www.scientistlive.com/eurolab
Anna Mills is senior validation specialist at Rapid Micro Biosystems, USA.
www.rapidmicrobio.com
A time line of cell growth.
Discover. Synthesize. Analyze. Customize.
Fisher Chemical UHPLC-MS Optima Solvents NEW solvent grade targeted for trace analysis by UHPLC-MS
Fisher Chemical UHPLC-MS Optima™ high-purity solvents are specifi cally qualifi ed for UHPLC-MS and offered in acetonitrile (A956), methanol (A458) and water (W8).
Features:
• Designed to ensure low metal ion adduct formation and improve peak profi les • Submicron fi ltration reduces instrument, column and check valves clogging • Solvent specifi cation based on S/N ratio of the propazine product ion from MS/MS fragmentation
• Borosilicate glass signifi cantly reduces leaching of metal cations (Na+
To place an order, contact your local Fisher Chemical distributor. For more information, go to
www.acros.com or visit us at Booth 14 at HPLC 2015.
UHPLC-MS Optima FC Solvents
DS_ADVERT_V04.indd 1 For more information ✔ at
www.scientistlive.com/eurolab 18/05/15 09:52 and K+ )
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