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 …
as lyophilized vial, liquid vial, and liquid prefilled syringe formulations. This review …
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 …
[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 …
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 …
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 …
documented phenomenon in the pharmaceutical industry. However, the underlying …
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 …
Impact of vial washing and depyrogenation on surface properties and delamination risk of glass vials
Purpose The proper understanding of glass delamination is important to glass
manufacturers, pharmaceutical companies, and health authorities to mitigate the occurrence …
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 …
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 …
environmental factors, including potential microbial contamination during shelf life duration …