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
Tony Stauffer
Shu-Chen Y. Chen
Yoojin Lee
Ronald Forster
Miron Ludzinski
Madhav Kamat
Phillip Godorov
Dana Morton Guazzo

References
- 1.↵
- McMaster R. C.
- 2.↵
- Morris D.
- 3.↵
- Carroll M.,
- Denny V.,
- Guazzo D.,
- Kaiser M.,
- Kirsch L.,
- Ludwig J.,
- Masover G.,
- May J.,
- Moldenhauer J.,
- Olsen J.,
- Polson T.,
- Wright G.
- 4.↵
- Guazzo D.
- 5.↵
〈1207〉 Sterile Product Packaging—Integrity Evaluation; United States Pharmacopeia 31; United States Pharmacopeial Convention, Inc.: Rockville, MD, 2007.
- 6.↵
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine. Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products, Guidance for Industry, 2008.
- 7.↵
- Nguyen L.,
- Muangsiri W.,
- Schiere R.,
- Guazzo D.,
- Kirsch L.
- 8.↵
- Kirsch L.,
- Nguyen L.,
- Moeckley C.,
- Gerth R.
- 9.↵
- Moore P. O.
- 10.↵
- Kirsch L.,
- Nguyen L.,
- Kirsch A.,
- Schmitt G.,
- Koch M.,
- Wertli T.,
- Lehmann M.,
- Schramm G.
- 11.↵
- McMaster R. C.
- 12.↵
- Schramm G.
- 13.↵
ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method; ASTM International: West Conshohocken, PA, 2009.
- 14.↵
United States Federal Register Notice, FR Notice (list #014), Docket No. 2004N-0226, 3 31, 2006, Volume 71, No. 62.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 63, Issue 5
September/October 2009
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;
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;
Jump to section
Related Articles
- No related articles found.
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
- Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions
- Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
- 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