TABLE V

Relative Contribution of Various Parameters on Injection Time

ParameterExample VariabilityMeasured RangeMax. % Variability in Force/TimeVariability in Injection Time (Target 10 s)
Friction forceNA1.8075 ± 0.3762 N±2.5%-
Barrel ID (2rb)6.35 ± 0.10 mm6.28–6.43 mm±4.0%±0.4 s
Needle (27 G) diameter (2rn)0.210 ± 0.019 mm+5.0%/−1.9%+20.0%/−7.5%+2.0 s/−0.75 s
Product concentration±10%±30% (viscosity)±30.0%±3.0 s
TemperatureTarget ±2 °C±10% (viscosity)±10.0%±1.0 s
Spring load21.58 N + 10–15%21.06 ± 0.61 N±15.0%±1.5 s
Worst case scenario (accumulation of all errors)∼80.0%10.0 ± ∼8.0 s