Article Figures & Data
Figures
- Figure 1
Exemplary images of frictive sliding and impact interactions found on filling lines. (a) Vials in motion slide past vials constrained by the inner guide on a rotary accumulator table. (b) A screw feeder accelerates and impacts vials into a large quantity of stationary vials on a dead plate.
- Figure 2
Representative damage on the surface of a glass vial processed on a conventional bulk filling line. Abrasion, chatter checks (a), and missing glass chips (b) are a result of glass-to-glass contact.
- Figure 3
Optical profilometry and cross-section of glass surface damage from Figure 2. (a) Abrasive damage with maximum depth of 6 μm; (b) missing glass chip with 20 μm depth.
- Figure 4
Illustration of the forces and stresses generated during sliding contact between vials macroscopically (a) and microscopically at the surface (b). The magnitude of the tensile stress and sheer stress are both proportional to the COF between the materials.
- Figure 5
Images of surface damage and debris field associated with frictive sliding contact with 1 mm scratch at various loads. Glass checking is also observed at the initiation of the scratch.
- Figure 6
Exemplary debris field generated during frictive sliding simulation at 10 N. The area outlined in white is analyzed by particle counting software.
- Figure 7
Glass particle distribution following a 1 mm scratch at 60 mm/min. Total particulate generation ranged from 1800 particles/mm scratch at 30 N to 700 particles per/mm scratch at 1 N. Little difference in the glass particle distribution is observed between loads.
- Figure 8
Glass particle distribution following a 1 mm scratch at 30 N. Little difference in the particle distribution is observed between speeds of 6 to 120 mm/min.
- Figure 9
SEM images of damage site produced using frictive sliding contact test (1 N load). A number of glass particles remain in the damage area following the scratch.
- Figure 10
Image capture of high-speed video illustrating visible glass particle ejection during impact testing. The size of the particle is >100 μm.
- Figure 11
Optical inspection of surfaces following 30 N scratch test. Significant damage and checks are observed on the conventional vial (a) while no glass damage is present on the new vial (b).
- Figure 12
SEM images of carbon tape contamination found following the line trial with the conventional vial. A significant quantity of glass particles were observed ranging in size from 1 to 15 μm.
Tables
Conventional Vial New Glass Vial Glass material Borosilicate (unstrengthened) Aluminosilicate (strengthened) Vial format/size ISO 2R, 3 mL ISO 2R, 3 mL Glass type (per USP <660> test) Type I Type I Exterior COF (post depyrogenation) 0.9 to 1.0 <0.5 Conventional Vial New Vial % Reduction Particle count range (0.5 μm/m3) 114–8609 100–337 96% (peak level) Total particle spikes 59 36 39% Particle spikes at in-feed 50 4 92% Interventions 247 95 62% Conventional Vial New Vial % Reduction Airborne particle count (wafer settling plate) 156 23 85% Solution particle counts (2–10 μm)* 1318 ± 136 761 ± 68 42% Solution particle counts (>10 μm)* 28 ± 6.9 14 ± 2.9 50% Solution particle counts (>25 μm)* 0.42 ± 0.52 0.23 ± 0.17 45% Interventions 15 3 80% ↵* Measured using light obscuration. Average of 20 samples from beginning, middle, and end of trial, average and standard deviation of number of particles/container reported.
Jump to section
- Article
- Abstract
- Introduction
- Filling Line and Vial Damage Characterization
- Glass Particles on the Filling Line Results from Multiple Mechanisms
- Lab Evaluation of Particle Generation from Each Damage Mechanism
- New Vial Designed To Address Root Cause of Particulate Mechanisms
- Line Trials Using the New Vial Demonstrate Substantial Reduction in Particle Risk
- Conclusions
- Conflict of Interest Declaration
- Acknowledgments
- Reference
- Figures & Data
- References
- Info & Metrics
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