Package Testing and Validation Services

Source: Distribution Dynamics Labs, Inc. (DDL, Inc, founding member of TestResources Group)

Package Testing and Validation Services
Testing Methods and Procedures in Support of Package Integrity Validation
Testing Methods and Procedures in Support of Package Integrity Validation
  • Shelf-Life Studies / Accelerated Aging
  • Transportation / Distribution Simulation
  • Package Integrity Testing
  • Microbial Barrier Testing
  • ISO 11607 Testing and Consulting

Sterile medical devices and packaging systems must perform consistently under variable sterilization, procedures, manufacturing conditions, and distribution hazards. In the device industry, it is generally accepted practice to evaluate the integrity of sterile medical device packages by subjecting a fully processed package to extremes in sterilization processes, performing a simulated distribution and handling stress test, and then evaluating the efficacy of the package for sterility maintenance through physical test methods or microbial barrier challenge. The test methods described offer a comprehensive and justifiable means of establishing package integrity and sterility.
DDL has been a leader and innovator in the package testing industry since 1990. We offer single source solutions to packaging engineers and manufacturer's who are concerned that their package would pass the test of time and meet regulatory agency requirements.
We provide...

Complete Documentation
Third Party Validation
Personalized and Efficient Service
Packaging Solution Assistance and Expertise
One Source for all Physical, Microbial, Dynamic and Aging Testing
Medical Device manufacturers are required to obtain 510(K) approval on each medical device package. Creating the package that achieves your shelf life claim is challenging. Testing and documenting it is where DDL comes in.

Shelf Life Studies/Accelerated Aging
Some domestic regulations and international directives require expiration dating on sterile medical device packages. However, expiration dating must be supported by documentation of shelf life performance through real time or accelerated aging methods.
Testing services include:

  • Protocol development
  • Variable temperature conditioning options
  • Thorough documentation of conditions
  • Package inspection and evaluation

Transportation/Distribution Simulation
Manufacturers must evaluate the packages ability to adequately protect the medical device through the handling and distribution environment. (ISO 11607, sec.6.5.1) Damage such as material puncture, abrasion, and seal failure may result from the dynamic events to which packages are subject.

Testing services include:

  • ASTM D 4169 Performance Testing of Shipping Containers and Systems
  • ISTA Project 1A Pre-Shipment Testing Procedure
  • Shock Testing
  • Vibration Testing
  • DOT Title 49 Compliance (UN Certification)

    Package Integrity Testing
    Packages may lose their integrity as a result of the dynamic related events which occur during processing and/or distribution. Physical test methods may be used to validate that the package integrity has been maintained throughout the packages processing, expected shelf life, and handling.

    Testing services include:

    • Package Leak Testing by Bubble Emission--ASTM D 3078
    • Package Leak Testing by Dye Penetration--ASTM F 1929
    • Seal/Peel Strength test--ASTM F 88
    • Burst/Creep Testing--ASTM F 1140
    • Peel Adhesion Testing--ASTM D 3330

    Microbial Barrier Testing
    In order to maintain the sterility of an enclosed product until it reaches its point of end use, the packaging must provide a microbial barrier in the post-sterilization environment. One method to evaluate the biobarrier properties of packaging is to challenge the packages with a microbial aerosol. The manufacturer must evaluate the microbial barrier properties of the package after exposure to the environmental stresses expected for a finished package.

    Testing services include:

    • Whole Package Microbial Challenge Testing
    • Ranking of Materials --ASTM F 1608
    • Material Porosity--Gurley Method
    • USP Sterility Testing

    ISO 11607 Testing and Consulting
    This international standard specifies the requirements for single use materials and re-usable containers for packaging of terminally-sterilized medical devices. The standard outlines principal requirements for packaging process development and validation of sterile medical device package designs.

    The following services are offered:

    • Protocol development
    • Process validation
    • Product Testing Services

    Products themselves must meet performance specifications to ensure they perform as intended. There are many different standards, guidance documents, and industry practices which address the performance and safety of medical devices.

    The following list provides some examples of the testing services which can be performed on products to meet safety and reliability regulations

    • ISO Product Performance and Safety Testing
    • IEC 68-2 Basic Environmental Testing Procedures
    • Mechanical/Tensile/Compression Strength Testing
    • Materials and Assemblies Strength Testing
    • Electrical Properties and Performance testing
    • Shock and Vibration Testing (fragility/durability)

    Distribution Dynamics Labs, Inc. (DDL, Inc, founding member of TestResources Group), 9675 West 76th Street, Suite 110, Eden Prairie, MN 55344. Tel: 612-941-9226; Fax: 612-941-9318.