Sterility testing is a crucial step in aseptic manufacturing. It is a process designed to demonstrate the presence or absence of external contaminating microorganisms in substances that are intended for human use.
What happens during sterility testing? Well samples of a batch are checked to verify the sterility of the entire batch.
Of course it is crucial that the working environment for testing is free from any contaminant that could invalidate the results.
2 different technologies can create the aseptic environment: Class A laminar flow booths or rigid wall isolators.
The laminar flow booth is a simpler and more cost-effective solution. To guarantee the required standard, it must be installed in a class B cleanroom and proper SOPs must be put in place and strictly followed to prevent any inadvertent background contamination caused by the operators.
A rigid wall isolator offers a more reliable alternative and it can be installed in a non classified environment (a Grade D is preferable but not mandatory). Rigid isolators guarantee a high level of protection (Grade A/ Class 100 conditions) throughout the execution of the task.
How does a sterility testing isolator work? It’s pretty simple: a decontamination cycle creates the aseptic quality inside the isolator and the absence of any potential background contamination that could lead to invalid results. And in addition the isolator works under positive pressure to prevent any contaminant from entering the working area.
