Chemical durability of type I glass vials

Reference Presenter Authors
(Institution)
Abstract
11-005 Sandra Balan Mendoza Jaime Jaime, S.B.(Institute of Food Technology); Bócoli, P.F.(Institute of Food Technology); Kiyataka, P.H.(Institute of Food Technology); Borosilicate glass vials or type I glass has been considered as useful and safe packaging material for pharmaceutical products by protecting its characteristics and guarantee its effectiveness. However, in recent years there has been a significant increase in the number of recalls of parenteral products due to the presence of glass flakes or lamellae in borosilicate glass vials. This phenomenon is called glass delamination, and even though type I glass vials, considered a high chemical stability material, are susceptible to chemical attack under specific conditions. To understanding some factors that may contribute for the occurrence of glass delamination, the influence of glass manufactures process (tubular or molded) and packaging volume (20 mL and 100 mL) were studied in this work. The durability of the inner surface of the glass vials was analyzed according to the requirements established in the USP Pharmacopoeia, chapter 1660, and evaluated by SEM – Scanning Electron Microscopy. By understanding the factors that may contribute for glass delamination, decisions can be taken to improve the production process and eliminate quality deviations to avoid the occurrence of the problem.
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