Non-Destructive Vacuum Decay Method for Pre-Filled Syringe Closure Integrity Testing Compared with Dye Ingress Testing and High-Voltage Leak Detection

References

1. 1.↵
   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. 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, Rockville, MD, 2008.
2. 2.↵
   ASTM F2338-09. Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method, ASTM International, West Conshohocken, PA, 2013, www.astm.org.
3. 3.↵
   1. Simonetti A.,
   2. Sabourin P.

   “Non-Destructive Vacuum Decay Method for Pre-Filled Syringes Closure Integrity Testing Compared with Dye Ingress Testing and High Voltage Leak Detection” PDA 2013 Universe of Pre-filled Syringes & Injection Devices Conference, Basel, Switzerland, November 6, 2013.
4. 4.↵
   SOP 284794. New Integrity Test for Closure Systems. Novartis Vaccines & Diagnostics, 2013.
5. 5.↵
   1. Wolf H.,
   2. Stauffer T.,
   3. Chen S. C.,
   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
6. 6.↵
   1. Guazzo D.

   Sterile product package integrity testing: current practice, common mistakes, new developments. PDA Metro Chapter 2011, May.
7. 7.↵
   2.9.20. Particulate Contamination: Visible Particles. European Pharmacopoeia; Council of Europe: Strasbourg France, 2010.
8. 8.↵
   3.2.9. Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders, Self-Sealing Test. European Pharmacopoeia; Council of Europe: Strasbourg, France, 2010.
9. 9.↵
   <381> Elastomeric Closures for Injections, Self-Sealing Capacity. United States Pharmacopeia; United States Pharmacopeia Convention: Rockville, MD, 2009.
10. 10.↵
    SOP 295059 Closure Containers Integrity Test—Dye Intrusion Test. Novartis Vaccines & Diagnostics, 2012.
11. 11.↵
    1. Singh S. P.,
    2. Burgess G.,
    3. Singh J.,
    4. Lockhart H.

    High-altitude testing and evaluation of liquid pharmaceutical glass and plastic bottles to detect teaks. J. ASTM Int. 2007, 4 (3).
12. 12.↵
    ASTM D3903-03 (2007) “Standard Specification for Rubber Seals Used in Air-Heat Transport of Solar Energy Systems”, ASTM International, West Conshohocken, PA, www.astm.org.