Sterility testing is an important step in aseptic production. It is a process designed to demonstrate the presence or absence of external contaminating microorganisms in substances intended for human use.
Two different technologies by FPS can create an aseptic environment: class A laminar chambers or rigid isolators.
The laminar flow chamber is a simpler and more economical solution. In order to guarantee the required standard, it must be installed in a class B cleanroom, with strict adherence to proper requirements, to prevent any unintentional contamination caused by operators.
A rigid isolator is a more reliable alternative and can be installed in an unclassified environment (Class D is preferred but not required). Rigid isolators guarantee a high level of protection (class A / class 100 conditions) throughout the entire cycle of the task.
How does the sterility test isolator work? The decontamination cycle ensures aseptic quality inside the isolator and the absence of any potential background contamination that could lead to incorrect results. In addition, the isolator operates under positive pressure to prevent any contaminants from entering the work area.
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