Historical review of glasses used for parenteral packaging
Glass has long been used for packaging precious liquids, in particular pharmaceuticals. Its
unique combination of hermeticity, transparency, strength, and chemical durability make it …
unique combination of hermeticity, transparency, strength, and chemical durability make it …
Evaluation of glass delamination risk in pharmaceutical 10 mL/10R vials
Glass delamination is characterized by the dissociation of glass flakes from the glass
surface. Since glass delamination is time dependent, 5 vial types were investigated to …
surface. Since glass delamination is time dependent, 5 vial types were investigated to …
Characterization of surface properties of glass vials used as primary packaging material for parenterals
The appropriate selection of adequate primary packaging, such as the glass vial, rubber
stopper, and crimp cap for parenteral products is of high importance to ensure product …
stopper, and crimp cap for parenteral products is of high importance to ensure product …
Glass containers for parenteral products
R Swift, R Schaut, CR Flynn… - Parenteral Medications …, 2019 - taylorfrancis.com
This chapter discusses the important elements of extractables and leachables, with which
those in the pharmaceutical industry should be familiar. Drug products, biological products …
those in the pharmaceutical industry should be familiar. Drug products, biological products …
Investigating the effects of the chemical composition on glass corrosion: A case study for type I vials
S Panighello, O Pinato - PDA Journal of Pharmaceutical Science …, 2020 - journal.pda.org
Glass is the favorite material for parenteral packaging because of its physico-chemical
properties. Type I borosilicate glass is worldwide use at this scope, but it may have some …
properties. Type I borosilicate glass is worldwide use at this scope, but it may have some …
Assay for characterizing adsorption-properties of surfaces (APS) used for sample preparation prior to quantitative omics
B Siebels, M Moritz, D Hübler, A Gocke, H Voß… - bioRxiv, 2023 - biorxiv.org
Analytes during their journey from their natural sources to their identification and
quantification are prone to adsorption to surfaces before they enter an analytical instrument …
quantification are prone to adsorption to surfaces before they enter an analytical instrument …
Materials in manufacturing and packaging systems as sources of elemental impurities in packaged drug products: An updated literature review
D Jenke - PDA Journal of Pharmaceutical Science and …, 2020 - journal.pda.org
Elemental impurities in drug products arise from different sources and via a number of
different means, including leaching of elemental entities (including the elements themselves …
different means, including leaching of elemental entities (including the elements themselves …
Assessment of Extractable Elements from Elastomers
D Paskiet, C Kraft, E Tullo, J Hunter… - PDA Journal of …, 2019 - journal.pda.org
Compendia methods have historically been used to assess heavy metals in both drug
products and packaging material extracts. However, these methods have been found to be …
products and packaging material extracts. However, these methods have been found to be …
Chemical Durability of Glass—Delamination
H Roehl, P Lam, D Ditter - Challenges in Protein Product Development, 2018 - Springer
Primary packaging containers used for the storage of parenteral drugs are designed to
protect the medicinal product from the environment to ensure patient safety. Mainly …
protect the medicinal product from the environment to ensure patient safety. Mainly …
Endotoxin and Microbiological Control
KL Williams - Endotoxin Detection and Control in Pharma, Limulus …, 2019 - Springer
The impermeability of the outer membrane (OM) of Gram negative bacteria (GNB) as well as
natural methods of disruption of these membranes (antibiotics, antimicrobial peptides and …
natural methods of disruption of these membranes (antibiotics, antimicrobial peptides and …