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Research ArticleResearch

Delamination Propensity of Pharmaceutical Glass Containers by Accelerated Testing with Different Extraction Media

Emanuel Guadagnino and Daniele Zuccato
PDA Journal of Pharmaceutical Science and Technology March 2012, 66 (2) 116-125; DOI: https://doi.org/10.5731/pdajpst.2012.00853
Emanuel Guadagnino
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  • For correspondence: eguadag@libero.it
Daniele Zuccato
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Abstract

The delamination of pharmaceutical glass is a serious issue, as it can cause glass particles to appear in vials, a problem that has forced a number of drug product recalls in recent years. In Type I pharmaceutical glass vials, delamination occurs generally at the bottom and shoulder, where extensive flaming during the conversion process can favor a strong evaporation of alkali and borate species and the formation of heavily enriched silica layers. The contact with parenteral preparations dissolved in an alkaline medium increases the rate of glass corrosion, while the differential hydration of these layers can cause the detachment of flakes. The purpose of this study was to investigate the effect of the pH and the composition of the extraction solutions on the propensity of different glass types to delaminate. Repeated autoclave extractions at 121 °C were carried out on different glass types with different extraction media, including organic extractants like citric and glutaric acid. When vials were in contact with alkaline solutions and similarly aggressive media, an increase in silica extraction values indicated glass corrosion and an increasing risk for further delamination. Under such conditions expansion 33 glass is extensively corroded, showing high silica concentration and heavy flaking as compared to other glass types. Sulfur-treated glass also showed early flaking, even if SiO2 concentration was very low. A similar ranking was observed with extractions carried out with glutaric and citric acids, but at far much higher SiO2 concentration levels. Extractions with 0.9% KCl solution can be used as an accelerated test to highlight the propensity of a glass to delaminate, but in no case it can be taken as a guarantee that the glass will not delaminate when exposed to the pharmaceutical drug, whose extraction ability requires case-by-case study.

LAY ABSTRACT: How can injectable drug manufacturers prevent glass delamination? The issue of delamination is a serious one, as it can cause glass particles to appear in vials, a problem that has forced a number of drug product recalls in recent years. To combat this, pharmaceutical and biopharmaceutical manufacturers need to understand the reasons for glass delamination. The most recent cases of product recall due to the presence of particles in the filling liquid have involved borosilicate glass containers carrying drugs made of active components with known ability to corrode glass and to dissolve the silica matrix. Sometimes these ingredients are dissolved in an alkaline medium that dramatically increases the glass corrosion and potentially causes the issue. As this action is strongly affected by time and temperature, flaking may become visible only after a long incubation during storage and requires systematic monitoring to be detected at its early stage. If the nature of the filling liquid is the driving force of the phenomenon, other factors are of primary importance. The surface morphology created during vial forming is a key issue, being a function of the forming temperature that is higher in the cutting step and the forming of the bottom. Delamination occurs generally on the vial's bottom and shoulder, where extensive flaming can favor a strong evaporation of alkali and borate species and the formation of heavily enriched silica layers. When these layers are in contact with a solution, they are subject to a differential re-hydration that may result in cracking and detachment of scales. The purpose of this investigation is to identify testing conditions and parameters that can be used as indicators of an incipient delamination process. Extractions with 0.9% KCl solution for 1 h at 121 °C can be used to simulate a long-term contact with aggressive pharmaceutical preparations, while SiO2 concentration in the extract solution can be taken as an index of glass dissolution. The conclusions developed by this study can provide pharmaceutical manufacturers with information needed to help prevent glass delamination in their processes.

  • Hydrolytic resistance
  • Delamination
  • Glass corrosion
  • ICP-OES
  • Accelerated extraction test
  • pH
  • Organic acid extractants
  • © PDA, Inc. 2012
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PDA Journal of Pharmaceutical Science and Technology: 66 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 2
March/April 2012
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Delamination Propensity of Pharmaceutical Glass Containers by Accelerated Testing with Different Extraction Media
Emanuel Guadagnino, Daniele Zuccato
PDA Journal of Pharmaceutical Science and Technology Mar 2012, 66 (2) 116-125; DOI: 10.5731/pdajpst.2012.00853

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Delamination Propensity of Pharmaceutical Glass Containers by Accelerated Testing with Different Extraction Media
Emanuel Guadagnino, Daniele Zuccato
PDA Journal of Pharmaceutical Science and Technology Mar 2012, 66 (2) 116-125; DOI: 10.5731/pdajpst.2012.00853
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  • Characterization of a Novel Particle in a Pharmaceutical Drug Product
  • Investigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I Vials
  • A Contribution to an Understanding of Complexing Agents and Salt Solutions Reaction Mechanism on Chemical Attack of Type I Molded Glass Containers
  • Introducing the Alba(R) Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation
  • Complexing Agents and pH Influence on Chemical Durability of Type I Molded Glass Containers
  • Historical Review of Glasses Used for Parenteral Packaging
  • Development of Conductivity Method as an Alternative to Titration for Hydrolytic Resistance Testing Used for Evaluation of Glass Vials Used in Pharmaceutical Industry
  • Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System
  • A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products
  • Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality
  • Particulate Study on NeoProfen, a Neonatal Injectable Product
  • Filtration of Glass Delamination Particles with West Pharmaceutical Vial Adapters
  • Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
  • Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
  • A Quick Test To Monitor the Delamination Propensity of Glass Containers
  • Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations
  • Determining the Delamination Propensity of Pharmaceutical Glass Vials Using a Direct Stress Method
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More in this TOC Section

  • A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
  • Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
  • Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
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