TME RESOURCES

• Seal Strength and Package Integrity Testing for the Food Packaging Industry
  • Introduction: The growth of barrier and retort pouch use in food packaging is a powerful driving force behind the need to define, standardize and institute critical seal strength and package integrity tests. Implementation of quantitative, repeatable package testing will help to ensure pouch quality, safety and standards.
    
    
• Pressure Decay Leak Testing
  • An overview of pressure and vacuum decay testing concepts, equations that are important in understanding how the tests work and how to design the appropriate leak test for your product or package, how statistical analysis can help you with process control, and other useful topics.
    
    
• Non-Destructive Closed Product/Package Testing - an Overview
  • A discussion of surrogate chamber pressure or vacuum decay testing as a non-destructive, highly sensitive method of detecting leaks in non-porous closed products or packages.
    
    
• Glossary of Terminology
  • A concise review of vocabulary and terminology often encountered in Leak Science. Very helpful as you design your leak, flow or package test and test system.
    
    
• Calibration versus Decay Measurements
  (PDF format only)
  • This paper presents a definition of each concept and a discussion of the difference between a leak tester's resolution (its ability to detect pressure change - decay - during a predetermined test time) and its accuracy regarding calibration to a known standard (its ability to reproduce a test pressure consistently at the beginning of the pressure decay leak test).

    In addition, a discussion is presented that examines issues related to pressure decay leak testing including environmental influences, factors limiting leak tester resolution, and the physics behind the pressure decay leak test.

• Strength & Integrity - the Basics of Medical Package Testing
  (PDF format only)
  • Originally published in three sections in Pharmaceutical and Medical Packaging News:"Strength & Integrity, Part 1: The Basics of Medical Package Testing" PMPN 10, No. 1(2002), "Strength & Integrity, Part 2: The Basics of Seal-Strength Testing", PMPN 10, No. 6 (2002), "Strength & Integrity, Part 3: Physical Package Integrity Testing", PMPN 11, No. 1 (2003), this paper expounds on the two facets of package testing advocated in ISO-11607, leak integrity tests and seal strength tests, focusing on the pressure or vacuum decay test for leak integrity, and the burst, creep and creep-to-failure inflation tests for seal strength.
    
    
• Principles of Operation - Force Decay
  (PDF format only)
  • Non-destructive leak tests for flexible packages can be accomplished by several methods that utilize various properties of the package form and materials. The force-decay method is particularly suited to pouch forms using non-porous materials such as films, foil or laminates in that this method presents advantages in speed and control for package forms used in food, medical device and pharmaceutical products. This paper discusses the force-decay test method.

• Testing Medical Device and Package Integrity
  (PDF format only)
  • Directed to medical device manufacturers and packagers but useful to all, this paper explores various leak test, flow test and package test methodologies designed to assure the end user that the product has been examined and has passed standard testing procedures designated by organizations including FDA, ISO and ASTM. It examines different product and package testing procedures, focusing on pressure decay leak tests and mass flow tests for product integrity, and seal strength tests and pressure decay leak tests for package integrit

• Calculating Factors of Safety for Package Burst and Creep Test Fixtures
  • The use of restraining plates in inflation tests such as pressure decay leak or seal strength package tests (burst test, creep test, creep-to-failure test) is explored. The focus is on safety factors that must be taken into consideration when determining proper design criteria, materials and processes for manufacture and maintenance of these flat plate fixtures.
    
    

• Comparing Tensile and Inflation Seal-Strength Tests for Medical Pouches
  (PDF format only)

  • Originally published in Medical Device & Diagnostics Industry: "Comparing Tensile & Inflation Seal-Strength Tests for Medical Pouches", MD&DI 20, No. 8 (1999), The goal of this paper is to clarify the relationship between tensile seal strength tests and inflation burst tests for the evaluation of package seal strength in order to help manufacturers establish more effective process control. Although originally published in a medical device magazine, the information is appropriate for any industry in which seal strength testing is indicated.

• Implications for Process Package Testing in ISO-11607
  • The ISO 11607 Standard, Packaging for Terminally Sterilized Medical Devices, is a guidance document that describes the process for design, development, validation, process control and final qualification of packages used in the protection of sterile medical devices. Even though this document is pointed specifically at the manufacturer of sterile medical devices, it is a well thought out vehicle to guide any package designer through the complexities of specialized package production.