Vacuum Decay Container/Closure Integrity Testing Technology. Part 2. Comparison to Dye Ingress Tests

References

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

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2. 2.↵
   ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method; ASTM International: West Conshohocken, PA, 2009.
3. 3.↵
   〈381〉 Elastomeric Closures for Injection. United States Pharmacopeia 31; United States Pharmacopeial Convention, Inc.: Rockville, MD, 2007, First Supplement.
4. 4.↵
   European Pharmacopoeia 6.0, 3.2.9 Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-dried Powders, European Directorate for the Quality of Medicines and Healthcare: Strasbourg, France.
5. 5.↵
   ISO 8362-5 Injection Containers for Injectables and Accessories—Part 5: Freeze drying closures for injection vials, Annex C Test Method for closure/container integrity and self-sealing, International Organization for Standardization: Geneva, Switzerland.