Sterility Testing
Sterility testing is a critical process used to ensure that products, such as pharmaceuticals and medical devices, are free from viable microorganisms. This testing is essential for maintaining safety and efficacy, as contamination can lead to serious health risks. The tests typically involve culturing samples in specific growth media and monitoring for microbial growth over a defined period.
There are various methods for sterility testing, including the Membrane Filtration method and the Direct Inoculation method. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), set guidelines for these tests to ensure consistency and reliability in the results, ultimately protecting public health.