66 BIOTECHNOLOGY
Anna Mills on automating key microbiology quality control tests
The ‘LAB IN A BOX’ T
he pharmaceutical microbiology QC lab can often be seen
Environmental cassettes can be used for all environmental tests, including finger dabs, contact plates and active air monitoring
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as a roadblock to getting pharmaceutical products to market faster. Regulatory requirements demand that microbial testing be performed with in-process and finished product, as well as the manufacturing environment. Samples must be safely taken out of clean areas and taken to the lab where they are painstakingly processed using manual techniques. Te time and expense needed to get microbiological results has led many pharmaceutical companies to outsource microbiology, leading to further time delays and also additional costs per test. Although there are many and varied rapid techniques
that attempt to address this issue, there are few that can incorporate the entire catalogue of requirements laid out by pharmaceutical companies. Te key need of pharmaceutical manufacturers is that any new method address the entire range of key tests typically carried out in the quality control lab, namely environmental monitoring, bioburden testing, water testing and sterility testing. In addition, any solution should seamlessly fit into the existing processes and offer streamlined validation. Tis includes providing results in colony forming units (CFUs), mimicking the existing preparation method, and integrating into a LIMS. Te optimal solution for the QC lab is a rapid microbiology technology that is essentially
a ‘lab in a box’ – a single technology to support the key microbiology tests without significant process changes. Automated technologies, such as the Growth Direct System, offer this type of capability.
Environmental monitoring For environmental monitoring, it is critical that any new technology support the capture of samples using similar methods. Any new cassettes must be similar to a traditional contact plate. In addition, a protected no growth area around the outside can guard against cross contamination. Te media must be the generally accepted media, such as TSA plus Lecithin and Polysorbate 80 and TSA plus Lecithin, P80, Histidine
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