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Package Validation Testing

Life Science Outsourcing is committed to providing thorough validation and testing that ensure compliance and effective packaging.

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Package Validation Testing Expertise

Package validation testing services ensure compliance with to the ISO 11607 standard, which states the manufacturer must ensure the product and package system conjoin to create a complete product which performs efficiently, safely, and effectively in the hands of the user.

Package Validation Testing Requirements

Package Validation Testing is vital to ensure integrity of the package’s seal.

Validation will provide assurance and security that a package is sealed properly, leak-free, and secure from any number of outside contaminants.

Accelerated aging should take place after the integrity of the product and package has been determined.

The main culprit for feeble package strength is the seal-sealing parameters. If a formal validation of the sealer is not carried out, the medical device manufacturer can expect failure. Packages may also lose their integrity during processing and / or distribution. Package Validation Testing may be used to validate that the package integrity has been maintained throughout the package’s processing, expected shelf life, and handling.

Testing includes, but is not limited to:

  • ASTM F1886
    Visual Inspection Test
  • ASTM F88
    Peel Strength Test
  • ASTM F1140
    Burst Test
  • ASTM F1929
    Dye Penetration Test
  • ASTM F1140
    Creep Test
  • ASTM F2096
    Bubble Emission Test

Let’s work together

Life Science Outsourcing prides itself on our role as partners in bringing medical innovations to life. That partnership forms the foundation of what sets us apart.