You were already informed that an expansion investment has further increased seeurity of our hpt future. The time is now ripe to start running our new hpt cleanroom ii sinee s" july 2010, our machines are being installed in this location. Additionally to the expansion of our cleanroom produetion, investment has been made into a new injection blow moulding maehine whieh will also be put into operation there in the next eouple of weeks. In order to ensure compliance to both pharmaceutical and specific customer requirements, extensive qualification of our new cleanroom, machines and production tools is carried out.our validation master plan and realisation of aetions for sopz3.0 change control are the basis of this extended qualification. Little by little, all production lines will be installed and aeeordingly qualified. On every line, a validation lot will be made prior to offieial produetion start. The production ability of our lines to any batch production will be verified with the help of systematie tests. It goes without saying that in the runup of all activities the complete proeess including transfer of produetion maehines and tools was planned and a risk analysis was made.our relocation only applies for production processes like injection moulding, injeetion blow moulding and injection stretch blow moulding. Our extrusion blow moulding equipment will remain in the existing cleanroom i. Environmental conditions of new cleanroom hpt ii exactly conform to theexisting cleanroom production according to gmp class c, iso class 8 in operation. Qualification will follow again din en iso 146441.completion of all installation and qualification is planned for end of august. In order to give you the opportunity of evaluating the proper realisation of these activities, you will afterwards be able to see all corresponding documentation within the frame of an audit in our house. Furthermore, we would like to inform that all measures put into practice in our certified company are according to is0153782006 and will also be adopted in our new cleanroom production.
