was tested on the drug product all materials chemicals and equipment used in the final fill of the exemplary drug product are listed in tables 17 through 19 the composition of an exemplary embodiment of the drug product is rhug at 5 5 mg ml and sodium chloride at 0 9 w v all filling operations were performed in a class 100 environment room both the room and the operations for fill were validated by the operator an omnispense pump was set up with 2 mm tubing primed and set to fill to a weight of 2 0 g u00b1 5 1 90 2 10 ml a flowchart outlining the fill processes is shown in fig2 a two ml vial was tared and bulk rhug was dispensed into the vial after filling the weight of the vial was recorded this procedure was repeated two times if the fill weights of the three vials were all within the specified range then all of the vials were filled if a vial fell out of the specified range the dispenser volume was adjusted and the process was repeated after filling vials were stoppered manually and aluminum crimp seals were placed onto the vials the vials were crimped using a kebby power crimp vials were then labeled and inspected visually the rhug drug product produced in this manner provides a clear colorless solution with no visible particulates rhug is a dimeric protein with a molecular weight of 16110 kilodaltons as calculated from the amino acid sequence and confirmed by electrospray mass spectroscopy the.