Benoit, Really appreciate your feedback. The new Environmental Monitoring System at the new site will be fully validated. I just wanted to confirm if there were any regulatory requirements to fully re-map the relocated refrigerators. I have discussed this with various refrigerator suppliers and they all agree that provided the new location has similar ambient environmental conditions then the refrigerator should perform the same. The only issue they had was possible transit damage, hence some level of OQ would still be required. But the thermal profile inside any refrigerator would only be influenced by the internal fan, shelving layout or content layout. Hence the hot/cold spots should not move due to a relocation. I am suggesting perhaps a limited temperature mapping be undertaken to confirm that the existing hot/cold spots are still within the required parameters, which would be incorporated into an OQ. Nick Sarris Red Cross Blood Service Melbourne Australia
