Operation within predefined limits

Solvent purities exceed 99%, with total control of all impurities to below 0.1% each. Recovery yields are up to 95%. The recovery processes are fully validated such that any generated products will pass pre-established quality specifications if the process is operated within predefined limits. 

This device controls the generator and maintains a steady-stale armature voltage automatically within the predefined limits. It also serves to control the reactive kVAr loading during a parallel operation or when the machine is being used as a synchronous condenser for reactive power compensation through a quadrature droop control (QDC) as noted below. 

The acceptance criteria for a successful operation qualification are based on the current ICH tolerance limits of 2°C for temperature and 5% RH for humidity [6, 7]. As it is expected that the temperature and humidity uniformity of an empty chamber would be superior to that for a chamber containing product, the acceptance criteria for successful OQ is set tighter than the ICH tolerance limits to ensure that the chamber will meet the required specifications during normal use. Therefore, at each location within the stability chamber, it is recommended that the temperature and humidity should be within 1°C and 4% RH of the predefined chamber set point. 

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