A further technological highlight within the new hameln pharma sterile production plant is the enhanced supply with high purity media: sterile air, ultra-pure steam and water for injections.High-performance water facility
With a new water facility hameln pharma can produce within one hour 5000 litres of HPW (highly purified water). From this 2.6 tons of ultra-pure steam is produced each hour for sterilising production batch and filtrate containers, the filling lines, autoclaves and all the machine parts that come into direct contact with the product.A further 3000 litres of HPW are processed each hour in addition for water for injections (WfI) via distillation.
To keep the distribution system of feeds, pipes, connectors and valves between the water processing and filling lines reliably sterile, hameln pharma has converted the entire water processing and distribution into the form of a loop system. The water moves continuously within this loop and is kept permanently at a temperature of 80 degrees.
Filtered air
hameln pharma has integrated four independent air filtration units into the new sterile production plant which produce a total air output of 180,000 cubic metres per hour to spply the 4000 square metre large clean room area with sterile air. All the air filtration facilities are monitored and maintained via a directly accessible pharmaceutical cleanroom ceiling.next