We use cookies to deliver the best possible experience on our website. To learn more, visit our Privacy Policy. By continuing to use this site, or closing this box, you consent to our use of cookies.


Functionality and Performance

Good patient outcomes depend upon performance of the drug product delivery system – both ease of use and reliability of delivery.  Achieving these requires proper design and materials selection, and extensive testing – employing  Quality by Design principles where possible. This section presents papers that consider these topics.

Coring and Fragmentation of Elastomeric Closures
By: Jia Min Boo

Link: Coring and Fragmentation of Elastomeric Closures

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.

Link: https://www.iso.org/obp/ui/#iso:std:iso:11040:-8:ed-1:v1:en

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%.

Link: http://www.transparencymarketresearch.com/us-eu5-prefilled-syringe-small-molecule-market.html

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.

Link: http://journal.pda.org/content/65/5/468.abstract