Functionality and Performance
Coring and Fragmentation of Elastomeric Closures
By: Jia Min Boo
Prefilled syringes — Part 8: Requirements and Test Methods for Finished Prefilled Syringes. ISO 11040-8:2016
Administration of drug products in pre-filled syringes is becoming ever more prevalent based on ease of use – either via self-administration or a clinician. This document specifies requirements for pre-filled syringes regarding quality, functional performance, safety, and relevant test methods.
Prefilled Syringe Small Molecule Market
(Therapeutic Class - Neurology Drug, Cardiovascular Drugs, Analgesics, and Adjuvants) - U.S. and EU-5 Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016 - 2024
This summary discusses projected growth (by indication) in pre-filled syringe use for small molecules in US and Europe through 2024. Combined annual growth rate (CAGR) is projected at 6 – 8%.
Variability in Syringe Components and its Impact on Functionality of Delivery Systems.
N. Rathore, et al. PDA J Pharm Sci Technol, 65, 468-480 (September/October 2011) - (available to PDA members – nonmembers may download for a fee)
This paper considers the effects of container and device components (i.e., barrel size, needle size, autoinjector spring force) on syringe performance in an automated delivery system. A model considering the basics physics is used to correlate the data.