Testing for sterility is a very important aspect of quality control for medical devices. There are various procedures for this. Testing using the BACTEC™ system is an alternative method that can only be used to test liquid samples.
Sterility testing of liquid samples (in-house procedure)
Testing for sterility using the BACTEC™ system is an alternative method to sterility testing of liquid samples. Instead of measuring turbidity,CO2 released by growing microorganisms is measured, which reacts with a fluorescent dye. This fluorescent dye is detected by the BACTEC™ system, which identifies the sample as “positive” if a threshold value is exceeded, i.e. it indicates the growth of microorganisms.
The method offers the advantage of real-time monitoring of the samples: The continuous fluorescence measurement makes it possible to determine to the minute when growth has occurred. Subcultivation of the sample can then be used to determine which microorganisms were present.
This sterility test is an in-house procedure that is not based on any standard. Only liquid and unclouded samples can be analyzed. Before the process can be used, product-specific validation is required, which is individually tailored and therefore not part of the routine.
We are happy to support you with your questions about bacterial endotoxins at
freigabe@gfps.de
.