Division 3 In the case of a continuous pressure system:

the temperature and the pressure must be monitored with thermocouples, or an infrared temperature gun, and pressure gauges must be used at defined positions throughout the process system in such a way that temperature and pressure comply with the required conditions inside the whole continuous system or in a section of it; the temperature and pressure must be plotted against real time;

measurement of the minimum transit time inside the whole relevant part of the continuous system where the temperature and pressure comply with the required conditions, must be provided to the competent authorities, using insoluble markers, such as manganese dioxide, or a method which offers equivalent guarantees.

Accurate measurement and control of the material process rate is essential and must be measured during the validation test in relation to a CCP that can be continuously monitored such as:

1. (i)

   feed screw revolutions per minute (rev./min.);

2. (ii)

   the electric power (amps at given voltage);

3. (iii)

   the evaporation/condensation rate; or

4. (iv)

   the number of pump strokes per unit time.

All measuring and monitoring equipment must be calibrated at least once a year.