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parametric release

Standard

ECSS-Q-ST-70-56C and Q-ST-70-57C DFR 1: Start of Public Review (End: 22 March 2013)

Definition

declaration that a product is at a certain bioburden level, based on records demonstrating that the process parameters were delivered within specified tolerances

Notes

  • NOTE Parametric release can be used for achieving bioburden reduction with heat (temperature and time record sufficient, no need for biological test) but is not acceptable for bioburden reduction using chemicals (biological test for process monitoring is mandatory).

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