An innovative shock-absorbing blue silicone shell to reduce breakage of veterinary pharmaceutical glass vials

Abstract

Although glass is an excellent material for manufacturing containers for pharmaceutical use, it remains fragile. This study aimed to support the qualities of glass by protecting the bottles with a shell made of polysiloxane elastomer, and to compare the relative resistance to breakage of this combination with that of a specifically designed plastic bottle.320 vials (250 and 500 ml) made of both glass and plastic, containing injectable veterinary drugs, were subjected to serial drop tests. A first group of containers (SCG: Silicone-Coated Glass) made of Type-1 glass were protected at the shoulder and bottom by a blue silicone soft shell, while those in the second group (LAS: Layered Anti-Shatter) were made of layered shatter-resistant plastic available on the market. Drop tests were carried out at three different angles (0°, 45°, 90°) from the vertical axis of the drop, from two drop heights (80 and 120 cm). All drop conditions (angle, height) and packaging (250 and 500 ml) combined, the risk of breakage of SCG vs LAS vials was RR=0.250 (shattered/intact ratio: 6/154 vs 24/136, 95% CI [0.105;0.595], P=0.002). Up to h=80 cm, no SCG (250 or 500 ml) was broken (0/80), compared to 9/71 for LAS (RR=0.053, 95% CI [0.003; 0.889], P=0.041). The 45° drop on the heel of the bottle produced the most damage for LAS containers (0/80 vs 23/57, RR=0.021; 95% CI [0.001; 0.344], P=0.007). In the event of an accidental fall, the contents of the glass bottle in a silicone shell are significantly better protected than in the multi-layer plastic bottle.