BIOTECHNOLOGY 67
and Sodium Tiosulphate, to sufficiently neutralise residual disinfectants. Te cassette itself can therefore be used as a contact plate, finger dab and active air sampling cassette. Because of this, sampling procedures and media are kept the same, making validation simpler than often feared.
Bioburden cassettes Much like the environmental monitoring case, any new bioburden testing method must closely match the existing sample preparation technique. Cassettes should be similar to current filtration cassettes, and use traditional media. Tere must also be a filtration funnel that includes a membrane to be placed on the cassette following filtration.
Sterility
Tere are several critical aspects to the sterility tests that must be replicated with any new method. First, the method needs to be closed loop to ensure no cross-contamination at any time in the process. Te test should closely replicate the filter testing currently performed in isolators or biosafety cabinets. Finally, the test must replicate the three conditions of the current sterility test: aerobic at 22.5°C; anaerobic at 32.5C; and aerobic at 32.5°C.
An example of such a method
is the Growth Direct Sterility test. Samples are filtered using a peristaltic system and the tubing, with the addition of the media using a different channel on the same tubing, capping off the cassette and
Bioburden cassettes are similar to current filtration cassettes
(in the case of the anaerobic cassette) pulling a toggle in order to create an anaerobic environment. Mimicking sample
preparation is only part of the solution. To achieve a lab in a box, the samples need to be loaded into an automated technology that can replicate the manual steps performed today. An example technology,
the Growth Direct System, takes prepared samples, identifies the correct test for each individual sample, and performs testing at the correct temperature and for the correct incubation time in a fully automated manner, reporting results in about half the time, and alerting the lab to any samples of interest. Advanced imaging technology detects growing colonies at as few as around 100 cells. Custom algorithms record the CFU counts (or positive in the case of sterility) and provide regular updates as the assay progresses. Because all samples are sealed during sampling, there is no need for the instrument to be located in the laboratory. Te technology is easy to use and CFR 21 part 11 compliant, ensuring data integrity.
Te microbiology quality
Above: Sterility cassettes and tubing
control lab struggles with manual methods and a high workload of tests that are critical to the safety of pharmaceutical products. Introducing a technology such as the Growth Direct System, which can automate and accelerate the key tests without significant changes to current processes, would increase the efficiency of the lab.
For more information ✔ at
www.scientistlive.com/eurolab
Right: The blue light is shined on the cassette to allow the bacterial cells to auto-fluoresce, enabling the light signal to be detected by a CCD camera
Anna Mills is with Rapid Micro Biosystems. www.
rapidmicrobio.com
www.scientistlive.com
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