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%.
Challenges in the Development of Pre-filled Syringes for Biologics from a Formulation Scientist’s Point of View.
M. Adler (2012)
This articles discusses parameters that influence syringe performance, including syringe/needle dimensions, contents viscosity, delivery rates, temperature, leachables/impurities, and silicone oil lubricants.
Future Materials for Prefilled Syringe Components.
P.H. Kiang. American Pharmaceutical Review, 14 (5) (2011)
This article discusses the benefits and limitations of materials that comprise the components of pre-filled syringes, i.e. glass, polymer (e.g., cyclic olefin polymer), rubber, coatings/films (e.g. fluoropolymer, silicone), metals.
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.