Sterility test
צוות מקצועי | 28 ביולי 2021
Sterility testing a critical part of every sterilization validity. This process for raising microorganisms has been in existence for a long time. It is a microbiology necessity to confirm if sterile products do not contain possible organisms before they are released and administered to a patient. The Sterility test methods usually require 14 days, but rapid methods can reduce to five days or less.
• Membrane Filtration Sterility Testing
The samples for the Sterility test are put through a membrane filter in a canister for filtration then a culture medium is put in for incubation. The method can offer high sensitivity than other methods as the sample will pass through a single filter. The filtration process gives a chance to wash off any components in the specimen that may prevent growth, like antibiotics or preservatives.
Direct Inoculation Method
In the direct inoculation method, a small sample volume is extracted from the unit sample and directly injected into an appropriate growth medium before the incubation process, which takes two weeks and is checked daily for microbial growth. This method is for medical devices and pharmaceutical products that are non-filterable in powder, ointment, and cream.
•Precautions against microbial contamination
A sterility test should take place in aseptic conditions. Adapting the environment for carrying out microbiological tests to the mode of examination performed will achieve these conditions. The working conditions in the Molecular biology lab services perform frequent monitoring of the tests through the work areas' appropriate sampling and appropriate controls.
Final Thoughts
Regulations that govern the pharmaceutical industry recommend sterility testing as a requirement. When change comes up during the process or when new personnel starts to compound, sterile testing occurs. It will happen on top of testing on a regular recurring basis. The method used for testing the product must be appropriately validated to reduce the probability of giving a false negative result.
