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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

Abstract:
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

Abstract:
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


Challenges in the Development of Pre-filled Syringes for Biologics from a Formulation Scientist’s Point of View. 
M. Adler (2012)

Abstract:
This articles discusses parameters that influence syringe performance, including syringe/needle dimensions, contents viscosity, delivery rates, temperature, leachables/impurities, and silicone oil lubricants.

Link: http://www.americanpharmaceuticalreview.com/Featured-Articles/38372-Challenges-in-the-Development-of-Pre-filled-Syringes-for-Biologics-from-a-Formulation-Scientist-s-Point-of-View/


Future Materials for Prefilled Syringe Components. 
P.H. Kiang.  American Pharmaceutical Review, 14 (5) (2011)

Abstract:

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.

Link: http://www.americanpharmaceuticalreview.com/Featured-Articles/37276-Future-Materials-for-Prefilled-Syringe-Components/


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)

Abstract:
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