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72 BIOTECHNOLOGY


Bringing the sterility test into the 21st Century


Anna Mills looks at a system that modernises sterility testing via automation and rapid results.


S


terility testing has remained unchanged for many years within the


pharmaceutical industry. Current testing relies on the filtration or direct inoculation of both Fluid Tioglycollate Medium (FTM) and Soya-Bean Casein Digest medium.


Tis method has been used by the European Pharmacopeia sector for many years and provides the user with the following challenges and risk factors:


The Growth Direct System for sterility testing.


l Turbidity. Tis is a subjective presence absence technique, which requires the user to make a judgement on whether the solution incubated does indeed contain growth.


l Turbid solutions. Any turbid solutions used need to have a further 4-7 days incubation added to declare them sterile, making the total incubation time 18-21 days rather than the general 14 days used. Tis extra step also adds the risk factor of a contamination event and therefore a potential false


positive. l Manual handling. As with all manual tests there are potential opportunities for mistakes in incubation and/or contamination events, leading to


the wrong result being reported. l Information handling. Traditional testing needs traditional results writing which can lead to transcription errors


and unclear handwriting. l Time taken. Te sterility result


is the highest risk result and has a direct effect on patient health. It also therefore has the longest incubation time and can create a bottleneck in terms of drug supply. It can also mean that a sterility failure can potentially remain undetected within a manufacturing line for up to two weeks, providing more time for contamination to become widespread with more potential product waste.


New systems based on proven technologies have created a solution for sterility testing with advanced automation and detection methods. Tese systems align closely with traditional testing, making them easier to validate. Te technologies also enable


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