VALIDATION OF ASEPTIC PROCESSES

PROCESS SIMULATION TEST PROCEDURES
4.1 General Comments

4.1.1 The media fill should emulate the regular product fill situation in terms of equipment, processes, personnel involved and time taken for filling as well as for holding.

4.1.2 Where filling takes place over extended periods, i.e. longer than 24 hours, the process simulation test should extend over the whole of the standard filling period. In order to prevent excessively high numbers of units being filled it is usually acceptable to just run the machine for a reasonable time, if the validity of the simulation is not diminished by this procedure.