Definition
A sample-free preparation carried through the entire process to establish what the process itself contributes. It is what separates contamination in the sample from contamination in the laboratory.
About contaminant testing
Endotoxin and elemental impurities, what neither of them establishes, and the microbiological vocabulary a reader still meets elsewhere.
Bacterial endotoxinEndotoxin unitPositive product controlMaximum valid dilutionTAMC and TYMCColony-forming unitSterilityElemental impurity