Evaluation of chemical durability of type I glass vials

• Grant number: 17/12369-0
• Support Opportunities: Regular Research Grants
• Start date: February 01, 2018
• End date: January 31, 2020
• Field of knowledge: Engineering - Materials and Metallurgical Engineering - Nonmetallic Materials
• Principal Investigator: Sandra Balan Mendoza Jaime
• Grantee: Sandra Balan Mendoza Jaime
• Host Institution: Instituto de Tecnologia de Alimentos (ITAL). Agência Paulista de Tecnologia dos Agronegócios (APTA). Secretaria de Agricultura e Abastecimento (São Paulo - Estado). Campinas , SP, Brazil
• Associated researchers: Paula Fernanda Janetti Bócoli ; Paulo Henrique Massaharu Kiyataka

Abstract

New pharmaceutical products development with complex formulations requires higher packaging performance. Borosilicate glass vials, also called as type I glass for injectable products for parenteral use has a successful history as safe and effective 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. Therefore, the present study aims to evaluate the chemical durability of glass vials used for parenteral products, aiming to correlate the potential of delamination occurrence due to the glass manufacture process, the packaging volume and the application of internal surface treatments. Thus, by understanding the factors that may contribute for the occurrence of glass delamination, decisions can be taken to improve the production process and eliminate quality deviations to avoid the occurrence of the problem. (AU)