Aseptic Processing
Manufacturing a sterile product by sterilising components and solution separately and assembling them under conditions that prevent contamination, used when the product cannot survive terminal sterilisation.
Why it is the harder route
There is no final sterilising step to cover an error, so sterility depends entirely on the contamination control strategy: air classification, personnel behaviour, transfer disinfection and filter integrity. Terminal sterilisation is always preferred where the monograph and molecule allow it.
How it is proven
Media fills simulating the full process at defined frequency, continuous Grade A/B monitoring, and container closure integrity testing by a validated physical method.
Related terms
Where this applies
General Injectables, Contrast Media
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