Development of syringes and vials for delivery of biologics: current challenges and innovative solutions

S Yoneda, T Torisu, S Uchiyama - Expert Opinion on Drug Delivery, 2021 - Taylor & Francis
Introduction Several new biopharmaceutical dosage forms have developed over time, such
as lyophilized vial, liquid vial, and liquid prefilled syringe formulations. This review …

Historical review of glasses used for parenteral packaging

RA Schaut, WP Weeks - PDA journal of pharmaceutical science and …, 2017 - journal.pda.org
Glass has long been used for packaging precious liquids, in particular pharmaceuticals. Its
unique combination of hermeticity, transparency, strength, and chemical durability make it …

[HTML][HTML] Viscosity of alumina doped soda lime silicate glasses–observation of anomaly in the linear increase as Al2O3 replaces SiO2

S Karlsson - Journal of Non-Crystalline Solids, 2021 - Elsevier
Adding alumina to the conventional soda lime silicate glass composition improves many
properties, however, also increases the melting temperature. In the current paper, alumina …

A holistic approach of extractables and leachables assessment of rubber stoppered glass vial systems for biotechnology products

L Qi, J Liu, M Ronk, A Gallegos, K Fujimori… - Journal of …, 2021 - Elsevier
Rubber stoppered glass vial systems are widely used as primary containers for storing and
delivering therapeutic protein products to patients. Addressing concerns and regulatory …

Freeze Drying and Vial Breakage: Misconceptions, Root Causes and Mitigation Strategies for the Pharmaceutical Industry

X Jin, D O'Grady, RP Affleck, S Martini… - Journal of Pharmaceutical …, 2024 - Elsevier
Vial breakage during or following freeze drying (lyophilization) is a well-known and
documented phenomenon in the pharmaceutical industry. However, the underlying …

Evaluation of glass delamination risk in pharmaceutical 10 mL/10R vials

D Ditter, A Nieto, HC Mahler, H Roehl, M Wahl… - Journal of …, 2018 - Elsevier
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 …

Characterization of surface properties of glass vials used as primary packaging material for parenterals

D Ditter, HC Mahler, H Roehl, M Wahl, J Huwyler… - European Journal of …, 2018 - Elsevier
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 …

Impact of vial washing and depyrogenation on surface properties and delamination risk of glass vials

D Ditter, HC Mahler, L Gohlke, A Nieto, H Roehl… - Pharmaceutical …, 2018 - Springer
Purpose The proper understanding of glass delamination is important to glass
manufacturers, pharmaceutical companies, and health authorities to mitigate the occurrence …

Particulate generation mechanisms during bulk filling and mitigation via new glass vial

CL Timmons, CY Liu, S Merkle - PDA Journal of Pharmaceutical …, 2017 - journal.pda.org
Contamination with foreign particulate matter continues to be a leading cause of parenteral
drug recalls, despite extensive control and inspection during manufacturing. Glass is a …

The pharmaceutical vial capping process: container closure systems, capping equipment, regulatory framework, and seal quality tests

R Mathaes, HC Mahler, JP Buettiker, H Roehl… - European Journal of …, 2016 - Elsevier
Parenteral drug products are protected by appropriate primary packaging to protect against
environmental factors, including potential microbial contamination during shelf life duration …