Vacuum Decay Container Closure Integrity Leak Test Method Development and Validation for a Lyophilized Product-Package System

References

1. 1.↵
   Department of Health and Human Services. Container Closure Systems for Packaging Human Drugs and Biologics, CMC Documentation, Guidance for Industry; U.S. Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research: Rockville, MD, 1999.
2. 2.↵
   Department of Health and Human Services. Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. Guidance for Industry; U.S. 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: Rockville, MD, 2008.
3. 3.↵
   ASTM F2338-09. Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method; ASTM International: West Conshohocken, PA, 2009.
4. 4.↵
   1. Wolf H.,
   2. Stauffer T.,
   3. Chen S.-C. Y.,
   4. Lee Y.,
   5. Forster R.,
   6. Ludzinski M.,
   7. Kamat M.,
   8. Godorov P.,
   9. Guazzo D. M.

   Vacuum decay container/closure integrity testing technology. Part 1. ASTM F2338-09 precision and bias studies. PDA J. Pharm. Sci. Technol. 2009, 63 (5), 472–488.

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5. 5.↵
   1. Wolf H.,
   2. Stauffer T.,
   3. Chen S.-C. Y.,
   4. Lee Y.,
   5. Forster R.,
   6. Ludzinski M.,
   7. Kamat M.,
   8. Mulhall B.,
   9. Guazzo D. M.

   Vacuum decay container/closure integrity testing technology. Part 2. Comparison to dye ingress tests. PDA J. Pharm. Sci. Technol. 2009, 63 (5), 489–498.

   OpenUrlAbstract/FREE Full Text