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
www.scientistlive.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92