Table 3 Sterility of epinephrine in prefilled syringes
From: A systematic review of epinephrine stability and sterility with storage in a syringe
Study | Concentration of epinephrine (mg/mL) | Type of epinephrine container used | Total # of samples tested | Sterility tests performed | Testing methods | Time at which sterility tested | Results |
|---|---|---|---|---|---|---|---|
Donnelly [22] | 0.1 | Plastic syringe | None | None | N/A | N/A | N/A |
Glass vial | |||||||
0.7 | Plastic syringe | ||||||
Glass vial | |||||||
Kerddonfak [24] | 1 | 1-mL disposable syringe, prepared under laminar flow hood | 6 syringes (2 per time point) | Tests for gram-negative bacteria, gram-positive bacteria, and fungal cultures | Syringes (1 mL each) tested for bacteria on blood agar incubated at 35 °C in air and for fungal cultures on brain heart blood agar incubated at 37 °C and sabouraud dextrose agar incubated at 37 °C | At each time point (after 1, 2, and 3 months of storage) for both conditions | No aerobic bacterial or fungal growths in any sample |
1-mL disposable syringe, prepared in open air | 6 syringes (2 per time point) | No aerobic bacterial or fungal growths in any sample | |||||
Zenoni [11] | 0.1 | 1-mL polycarbonate syringes | 6 syringes (2 at time zero, 2 stored at room temperature, and 2 stored at 2–8 °C) | Tests for sterility, absence of bacterial endotoxin, and the rate of particle contamination | Particulate test according to European Pharmacopeia, limulus amebocyte lysate (LAL) test for the presence of endotoxin, visual examination of the solution | At time zero and after 4 weeks | All tests negative: bacterial contamination absent, endotoxin levels < 0.125 EU/mL, no visually detectable changes in color or clarity of solution, invisible particle count (< 10 μm and < 25 μm) below detectable limits |