Glass has long been used for packaging precious liquids, in particular pharmaceuticals. Its
unique combination of hermeticity, transparency, strength, and chemical durability make it …

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 …

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 …

This chapter discusses the important elements of extractables and leachables, with which
those in the pharmaceutical industry should be familiar. Drug products, biological products …

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 …

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 …

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 …

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 …

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 …

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 …