Packaging Validations through Accelerated Aging & Sterile Barrier Testing
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.
11607 consists of two parts:
ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems
ISO 11607-2: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes
ISO 11607-1 outlines the general requirements for materials, sterile barrier systems, and packaging systems used for medical devices that need to be terminally sterilized. It addresses aspects such as materials selection, design considerations, and the integrity of the packaging.
ISO 11607-2 focuses on the validation of the processes used in forming, sealing, and assembling packaging for medical devices. This standard provides guidelines for establishing and maintaining the validation process to ensure the packaging maintains its integrity and sterile barrier properties.
The packaging validation process for medical devices according to ISO 11607 generally involves:
- Establishing a validation plan: Define the scope, objectives, methods, acceptance criteria, and responsibilities for the packaging validation process.
- Design and development considerations: Ensure that the packaging is designed to meet the requirements of the medical device and the sterilization process it will undergo.
- Material selection: Select packaging materials that are compatible with the sterilization process and maintain the sterility of the medical device.
- Sealing process validation: Validate the sealing process to ensure that it consistently provides an effective seal that maintains the sterile barrier.
- Integrity testing: Conduct integrity testing to verify the package's resistance to microbial penetration and to confirm that the sterile barrier is maintained.
- Performance testing: Perform performance testing to assess the overall functionality and suitability of the packaging under expected transportation and storage conditions.
- Documentation: Keep detailed records of the validation activities, test results, and any corrective actions taken during the process
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
