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Pharmaceutical Package Testing Industry Standards

DDL is experienced in performing tests that comply with the following pharmaceutical package testing industry standards:  

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ASTM Standards  
   
D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
D4991

Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method

F1929

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

F2096

Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

   
ISTA Standards  
   
ISTA

Pre-Shipment Test Procedure

   
PDA Journal of Science & Technology
   
Tech. Report #27 Pharmaceutical Package Integrity, 1998 Supplement, Vol. 52 , No: 52
Tech. Report #39 Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through The Transportation Environment, Sept/Oct 2005, Supplement, Vol. 59, No: 5 - 3
   

For more information on industry standards and compliance requirements for pharmaceutical package testing, please contact us today.