Historical Review of Glasses Used for Parenteral Packaging

Schaut, Robert A.; Weeks, W. Porter

doi:10.5731/pdajpst.2016.007377

Cited by 48 publications

(28 citation statements)

References 42 publications

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“…Porcelain containers have a long history of being used as traditional fermentation containers, and are popular vessels utilized in both the homemade and industrial production of pickles. The industry has recently welcomed the addition of glass jars as fermentation containers due to their stability, as well as their excellent ability to facilitate the transmission of light (Schaut and Weeks, 2017). However, it remains unclear whether the types of containers can influence the fermentation process of pickles.…”

Section: Introductionmentioning

confidence: 99%

Microbiota Succession and Chemical Composition Involved in the Radish Fermentation Process in Different Containers

et al. 2020

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Traditional Chinese fermented vegetables are a type of brine-salted fermented vegetable product. During the spontaneous fermentation, various compounds are produced, degraded, and converted, influencing the quality of the fermented pickle. To ascertain the effect of different containers on the fermentation process of the pickles, this study investigated the bacterial diversity and the chemical composition characteristics of the pickle (radish) fermented in commonly used containers including glass jars (GL), porcelain jars (PO), and plastic jars (PL). The correlation between chemical compounds and microbial community was further analyzed. The changes in pH values suggested that PL may facilitate the quickest fermentation of the pickles, while the process in PO progressed at the lowest rate. The PL brine samples contained higher levels of lactic acid and threonine, while more abundant volatile chemical compounds were evident in PO. The container materials had no significant influence on the microbial structure, wherein Lactobacillus was the absolute dominant genus in all containers. But container material did have an effect on the abundance of specific genus, such as Lactococcus and Pediococcus. The correlation between these major genera was also analyzed and gene function prediction indicated that the top three pathways were: carbohydrate metabolism, amino acid metabolism, and energy metabolism. Lactobacillus negatively correlated with methionine, tyrosine, lysine, and arginine, but positively correlated with ammonia, and lactic acid and acetic acid both just correlated with Pediococcus. This study provides new insights into the microbiota succession and chemical compounds involved in the vegetable fermentation.

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Section: Introductionmentioning

confidence: 99%

Microbiota Succession and Chemical Composition Involved in the Radish Fermentation Process in Different Containers

et al. 2020

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“…The second reason is that treatment with ammonium sulfate, which reduces the amount of alkali on the surface, decreases the amount of extractable elements, but increases the corrosion rate. 3,9 The third reason is the vial set was made to exceed the pharmacopeia limit of the USP <660> and Ph. Eur.…”

Section: Introductionmentioning

confidence: 99%

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

Guglielmi

Bessegato²,

Cerdan‐Diaz³

et al. 2020

Int J of Appl Glass Sci

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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.

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“…The use of glass for pharmaceutical keeps increasing, especially for new applications such as high-technology drugs, requiring the strictest container inertness. Indeed, high-end biotech products keep entering the market, posing new technical and regulatory challenges for the development of injection systems [1]. Among the primary containers, syringes and cartridges are becoming the key players thanks to their superior performances and easy usability, replacing the reconstitution filling procedures for vials.…”

Section: Introductionmentioning

confidence: 99%

An integrated DEM–FEM approach to study breakage in packing of glass cartridges on a conveyor belt

et al. 2020

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The use of glass for pharmaceutical new applications such as high-technology drugs, requires the strictest container inertness. A common theme of paramount importance in glass container integrity preservation is the detailed mechanism driving the sudden failure due the crack propagation. Using a combination of discrete element method (DEM) and finite element method (FEM), a stress map for glass cartridges packed into an accumulation table and transported by a conveyor belt at a fixed velocity is obtained under realistic conditions. The DEM calculation provides a full description of the dynamics of the cartridges, as approximated by an equivalent sphere, as well as the statistics of the multiple collisions. The FEM calculation exploits this input to provide the maximum principal stress of different pairs as a function of time. Our analysis shows that, during their transportation on the conveyor belt, the cartridges are subject to several shocks of varying intensities. Under these conditions, a crack may originate inside the cartridge in the area of maximal tensile stress, and propagate outward. Estimated stresses are found in good agreement with real systems.

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Historical Review of Glasses Used for Parenteral Packaging

Cited by 48 publications

References 42 publications

Microbiota Succession and Chemical Composition Involved in the Radish Fermentation Process in Different Containers

Microbiota Succession and Chemical Composition Involved in the Radish Fermentation Process in Different Containers

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

An integrated DEM–FEM approach to study breakage in packing of glass cartridges on a conveyor belt

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