Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
OtherResearch Paper

Coring and fragmentation of elastomeric needle shield in a pre-filled syringe

Sahab Babaee, Sean Teller, Kavin Kowsari, Nikolaos Vasios, Steven C. Persak, Nagi Elabbasi and Guangli Hu
PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2024-003041; DOI: https://doi.org/10.5731/pdajpst.2024-003041.1
Sahab Babaee
1Device Development & Technology, Merck Research Laboratories, Merck & Co., Inc., Rahway, NJ 07065, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: sahab.babaee@merck.com guangli.hu@merck.com
Sean Teller
2Veryst Engineering LLC, Needham, MA 02494, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Kavin Kowsari
1Device Development & Technology, Merck Research Laboratories, Merck & Co., Inc., Rahway, NJ 07065, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Nikolaos Vasios
2Veryst Engineering LLC, Needham, MA 02494, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Steven C. Persak
1Device Development & Technology, Merck Research Laboratories, Merck & Co., Inc., Rahway, NJ 07065, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Nagi Elabbasi
2Veryst Engineering LLC, Needham, MA 02494, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Guangli Hu
1Device Development & Technology, Merck Research Laboratories, Merck & Co., Inc., Rahway, NJ 07065, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: guangli.hu@merck.com sahab.babaee@merck.com
  • Article
  • References
  • Info & Metrics
  • PDF
Loading

Abstract

Elastomeric components such as closures and stoppers play key roles in providing container closure integrity (CCI), supporting a portfolio of injectable combination products and primary containers including needle shields (NS) in prefilled syringes (PFS). Upon piercing through elastomeric (i.e., synthetic rubber) components, the physical interaction between the needle and deformable elastomer could result in the formation of small, random-shaped particles fragmented and dislodged from the NS material due to cutting processes. This phenomenon, called coring, poses a major risk in drug product contamination as elastomer particle fragments can potentially be aspirated with the medication and injected into a patient or prevent injection. Here, we present a combined computational and experimental approach to assess the incidence of coring. In particular, we first experimentally characterized the non-linear finite deformation behavior of five commonly used NS elastomers and calibrated constitutive models. Then, we performed finite element simulations validated with needle insertion experiments to compare the coring behavior of the NS elastomers. We demonstrated that higher maximum failure strain under tension and higher deformation-stiffening properties of the elastomer are contributing factors that attenuate coring and fragmentation. The experimental-numerical framework presented is suitable for quantifying broad correlative and discovering relationships between device properties governing the incidence of coring and fragmentation.

  • prefilled syringe
  • rigid needle shield
  • coring
  • elastomer material
  • numerical modeling
  • Received December 23, 2024.
  • Accepted March 12, 2025.
  • Copyright © 2025, Parenteral Drug Association

PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.  

If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing. 

Full issue PDFs are for PDA members only.

Note to pda.org users

The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.

Log in using your username and password

Forgot your user name or password?

Log in through your institution

You may be able to gain access using your login credentials for your institution. Contact your library if you do not have a username and password.
If your organization uses OpenAthens, you can log in using your OpenAthens username and password. To check if your institution is supported, please see this list. Contact your library for more details.

Purchase access

You may purchase access to this article. This will require you to create an account if you don't already have one.

patientACCESS

patientACCESS - Patients desiring access to articles

Full issue PDFs are for PDA members only. You can join PDA at www.pda.org. 

PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 79 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 2
March/April 2025
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Coring and fragmentation of elastomeric needle shield in a pre-filled syringe
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
1 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Coring and fragmentation of elastomeric needle shield in a pre-filled syringe
Sahab Babaee, Sean Teller, Kavin Kowsari, Nikolaos Vasios, Steven C. Persak, Nagi Elabbasi, Guangli Hu
PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2024-003041; DOI: 10.5731/pdajpst.2024-003041.1

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Coring and fragmentation of elastomeric needle shield in a pre-filled syringe
Sahab Babaee, Sean Teller, Kavin Kowsari, Nikolaos Vasios, Steven C. Persak, Nagi Elabbasi, Guangli Hu
PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2024-003041; DOI: 10.5731/pdajpst.2024-003041.1
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing and Control Post Approval Change Pilot
  • Preservative efficacy testing of refrigerated pharmaceuticals: choice of challenging isolate and storage temperature
Show more Research Paper

Similar Articles

Keywords

  • prefilled syringe
  • rigid needle shield
  • coring
  • elastomer material
  • numerical modeling

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire