Glass Delamination: a Comparison of the Inner Surface Performance of Vials and Pre-filled Syringes

Abstract

The occurrence of glass delamination is a serious concern for parenteral drug products. Over the past several years, there has been a series of product recalls involving glass delamination in parenteral drugs stored in vials which has led to heightened industry and regulatory scrutiny. In this study, a two-pronged approach was employed to assess the inner surface durability of vials and pre-filled syringes. Non-siliconized syringes were used in order to directly compare glass to glass performance between vials and syringes. The vial and syringe performance was screened with pharmaceutically relevant formulation conditions. The influence of pH, buffer type, ionic strength, and glass type and source was evaluated. In addition, an aggressive but discriminating formulation condition (glutaric acid, pH 11) was used to ascertain the impact of syringe processing. Advanced analytical tools including inductively coupled plasma/mass spectrometry, scanning electron microscopy, atomic force microscopy, and dynamic secondary ion mass spectroscopy showed significant differences in glass performance between vials and syringes. Pre-filled syringes outperform vials for most tests and conditions. The manufacturing conditions for vials lead to glass defects, not found in pre-filled syringes, which result in a less chemically resistant surface. The screening methodology presented in this work can be applied to assess suitability of primary containers for specific drug applications.

Effects ofMyo-inositol on Type 1 Retinopathy of Prematurity Among Preterm Infants <28 Weeks’ Gestational Age

“…Delamination within glass vials is affected by both the glass manufacturing process and the chemical characteristics of the drug, particularly if acidic or caustic. 26,27 The glass lamellae subsequently found in 1.9% of stored vials in lot 2 of the trial drug raised the question whether the observed harmful effect of myo-inositol could have been due to these particles. However, detailed analyses revealed that there were no differences in the outcomes for infants treated with myo-inositol between the 2 lots of the trial drug.…”

Impact of Sterilization Method on Protein Aggregation and Particle Formation in Polymer-Based Syringes

“…However, glass presents inherent risks such as breakage and delamination, which may occur during the manufacturing processes, shipping, and/or storage. 2 In addition, lubricants such as silicone oil are commonly used to insure smooth operation of the plunger within the syringe barrel. The presence of silicone oil can lead to undesirable protein aggregation and particle formation in syringes, which in turn may cause adverse immune responses in patients.…”

Carbon radicals generated by solid polymers: Electron spin resonance spectroscopy for detection of species in water

“…The main component of a PFS is the barrel, which is traditionally made of glass. Recently, PFSs composed of plastic (polymer) barrels (P‐PFS) have been explored and applied practically to mitigate the problems associated with glass (e.g., shock resistance, delamination, silicone oil, and elution of tungsten oxide). Cyclic olefin polymers (COPs), cyclic olefin copolymers, and polypropylene have been used for this purpose .…”