Laboratory intercomparison for the evaluation of the delamination propensity of glass containers for pharmaceutical use

Abstract

This paper is the result of two round robin activities run by the Technical Committee TC12, Pharma Packaging, of the International Commission on Glass (ICG). It deals with the phenomenon of delamination, that is, the formation of lamellae or flakes in drug products due to specific and localized corrosion of glass vials, and it follows a first paper PDA J Pharm Sci Technol. 2018, 72, 553-565where a testing protocol for the evaluation of the delamination propensity was proposed. The results showed that the protocol gives information on the quality of vials with respect to the propensity to corrosion, but no direct correlation with delamination could be demonstrated, as no lamellae formation was observed. In response, further testing was carried out on five sets of vials with expected low delamination propensity, compared to a set of vials with high expected delamination propensity using both the proposed protocol and a more aggressive protocol. The objective was to observe lamellae at least in the high propensity vials to show a correlation to initial test protocols.

Glass: The best material for pharmaceutical packaging

“…24 With the aim to directly correlate testing results with the formation of flakes, a much more aggressive protocol inspired by the work published by Sloey 25 was used in the second part of the work. 26 In that case, clear and extensive delamination could be observed only in vials made using BS 33 with the inner surface treated with ammonium sulfate and converted from tubing under conditions aimed to give high delamination propensity (black line in Figure 5). The other borosilicate vials, produced by different companies and currently on the market, exhibited a negligible delamination in few vials, even after prolonged stress treatments (gray area in Figure 5).…”

“…However, the risk is always potentially present, and nowadays the focus is on trying to find tests that provide, as quickly as possible, a reliable indication of the propensity to delamination or, more generally, of the resistance to corrosion. Different protocols are suggested in the literature, [24][25][26][27][28] which try to overcome the limits of standard testing, but work is still in progress.…”

“…Indeed, during the initial work done by the ICG technical committee TC12 on delamination vials, 23 no delamination could be observed in all the examined vials, following a protocol based on a method published by Guadagnino and Zuccato in 2012 24 . With the aim to directly correlate testing results with the formation of flakes, a much more aggressive protocol inspired by the work published by Sloey 25 was used in the second part of the work 26 . In that case, clear and extensive delamination could be observed only in vials made using BS 33 with the inner surface treated with ammonium sulfate and converted from tubing under conditions aimed to give high delamination propensity (black line in Figure 5).…”

Advancing the Mechanical Performance of Glasses: Perspectives and Challenges

“…Sometimes this may be due to the more widespread use of glass products, for example, in direct, haptic user interaction (e.g., interactive displays, smart glasses, or textile structures). It may also be driven by new levels of functionality and safety requirements (e.g., smart windows, [10] but also pharmaceutical packaging [11] ), sustainability goals (lightweight objects with reduced embodied CO 2 , enhanced service life), upscaling efforts (e.g., chemically strengthened glass products, larger and/ or thinner windows or other glass structures in architecture), or emerging applications of specialty glasses. For example, glasses with adapted mechanical performance are expected to play important roles in 5G and mm wave technologies, [12] as membranes for gas separation, [13,14] or as microscale objects [15] such as in glass-based microfluidic reactors and sensor components or capillary devices.…”

Avaliação da resistência à delaminação de frascos de vidro tipo I para produtos injetáveis disponíveis no mercado brasileiro

“…A avaliação da resistência hidrolítica do vidro, metodologia utilizada em controles de produção e aprovação de lotes de embalagens, permite quantificar essas trocas iônicas, através da titulação da água com uma solução ácida. Parenteral Drug Association (PDA), para a discussão do problema de delaminação e outros, relacionados ao uso de embalagens de vidro para produtos farmacêuticos (Guglielmi, et al, 2020).…”