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
Research ArticleTECHNOLOGY/APPLICATION

Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies

Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski, Madhav Kamat, Phillip Godorov and Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology September 2009, 63 (5) 472-488;
Heinz Wolf
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Tony Stauffer
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Shu-Chen Y. Chen
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yoojin Lee
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ronald Forster
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Miron Ludzinski
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Madhav Kamat
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Phillip Godorov
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Dana Morton Guazzo
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: dguazzo@rxpax.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 63 no. 5 472-488
PubMed 
20158052

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online September 24, 2009.

Copyright & Usage 
© PDA, Inc. 2009

Author Information

  1. Heinz Wolf1,
  2. Tony Stauffer2,
  3. Shu-Chen Y. Chen3,
  4. Yoojin Lee4,
  5. Ronald Forster5,
  6. Miron Ludzinski6,
  7. Madhav Kamat7,
  8. Phillip Godorov8 and
  9. Dana Morton Guazzo9,*
  1. 1General Manager, Packaging Technologies & Inspection, LLC, Tuckahoe, NY 10707;
  2. 2President, Packaging Technologies & Inspection, LLC, Tuckahoe, NY 10707;
  3. 3Principal Engineer, Drug Product & Device Development, Amgen Inc., Thousand Oaks, CA 91320;
  4. 4Associate Engineer, Drug Product & Device Development, Amgen Inc., Thousand Oaks, CA 91320;
  5. 5Director of Package Design & Engineering, Drug Product & Device Development, Amgen Inc., Thousand Oaks, CA 91320;
  6. 6Senior Research Scientist, Drug Product Process & Package Development, Bristol-Myers Squibb Co., New Brunswick, NJ 08903;
  7. 7Senior Principal Scientist, Drug Product Process & Package Development, Bristol-Myers Squibb Co., New Brunswick, NJ 08903;
  8. 8Director, Interlaboratory Study Program, ASTM International, West Conshohocken, PA 19428; and
  9. 9President, RxPax, LLC, Pharmaceutical Package Development Consultants, Bridgewater, NJ 08807
  1. * Author to whom inquiries should be addressed. E-mail: dguazzo{at}rxpax.com
View Full Text

Cited By...

  • Citations
  • Google Scholar

This article has not yet been cited by articles in journals that are participating in Crossref Cited-by Linking.

PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 63 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 63, Issue 5
September/October 2009
  • Table of Contents
  • Index by Author
Print
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.
Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
(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.
5 + 7 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski, Madhav Kamat, Phillip Godorov, Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology Sep 2009, 63 (5) 472-488;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski, Madhav Kamat, Phillip Godorov, Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology Sep 2009, 63 (5) 472-488;
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Results and Discussion
    • Conclusions
    • Appendix
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
  • Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
  • Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy
  • Container Closure Integrity Testing--Practical Aspects and Approaches in the Pharmaceutical Industry
  • Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes
  • Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
  • Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions
  • Vacuum Decay Container Closure Integrity Leak Test Method Development and Validation for a Lyophilized Product-Package System
  • Vacuum Decay Container/Closure Integrity Testing Technology. Part 2. Comparison to Dye Ingress Tests
  • Google Scholar

More in this TOC Section

  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Show more Technology/Application

Similar Articles

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