TABLE II

Results of Test Method A Applied on Syringes, Vials, and Cartridges Expressed in parts per milliona

Container TypeAl2O3 (μg/mL)B2O3 (μg/mL)SiO2 (μg/mL)ΣNa2O (μg/mL)
MeanStd. Dev.MeanStd. Dev.MeanStd. Dev.MeanStd. Dev.
1 mL Long Syringes
    Bulk0.570.281.020.346.761.282.660.48
    Siliconized0.660.201.250.259.942.422.720.65
    Alba<LoQbc<LoQb2.010.230.430.06
    LoQb0.190.320.430.13
3 mL Vials
    Bulk0.800.392.720.6510.981.662.630.34
    Alba0.100.020.410.142.370.470.690.13
    LoQb0.090.160.210.07
3 mL Cartridges
    Bulk0.830.221.010.327.481.431.980.52
    Alba0.120.040.340.081.960.340.560.06
    LoQb0.090.160.210.07
  • a For each category 50 containers were analyzed. “Bulk” refers to untreated samples, “Siliconized” refers to samples treated with silicone oil process, and “Alba” refers to samples siliconized with Alba process.

  • b LoQ = Limit of Quantification.

  • c —, not applicable.