Life Science Outsourcing is committed to providing thorough medical device package validation testing that ensures compliance and effective, reliable packaging for our clients.
Ensure your medical device packaging meets regulatory standards, maintains sterility, and withstands real-world conditions. As part of our end-to-end solutions, we provide expert testing to prevent failures, recalls, and delays.
Medical device package validation testing uses a series of tests to validate that the packaging of a medical device will meet regulatory requirements and is able to protect the device from hazards during distribution, storage, and use.
Package validation testing typically involves:
Integrity testing
Integrity testing verifies that the packaging will maintain sterility and prevent microbial contamination.
Physical strength testing
This type of testing is conducted to assess packaging material durability along with seal and closure strengths.
Performance testing
Performance testing evaluates how well packaging performs under conditions such as temperature, humidity, and mechanical stress.
Package validation testing services ensure compliance with the ISO 11607 standard, which states that manufacturers must verify that the product and package system conjoin to create a complete product which performs efficiently, safely, and effectively in the hands of the user.
Medical device manufacturers, contract packaging companies, and regulatory bodies all use package validation testing to ensure patient safety, meet regulatory compliance requirements, verify product integrity, and bolster brand reputation.
A series of systematic tests and evaluations are performed to verify the packaging will effectively protect the device throughout its lifecycle.
Test plan development
A comprehensive development plan will include objectives, standards and guidelines, test methods, and acceptance criteria.
Package design evaluation
This evaluation includes material selection and seal integrity.
Performance testing
Performance testing includes multiple elements, such as accelerated aging testing, real-time aging testing, and distribution simulation testing.
Environmental conditioning
The packaging is exposed to various environmental conditions to assess durability and package integrity and can include temperature and humidity testing and altitude testing.
Sterility and microbial barrier testing
Microbial barrier testing tests the package for its ability to prevent microbial contamination. Seal integrity testing evaluates the strength and integrity of the seals through methods such as dye penetration, bubble emission, or vacuum decay.
Physical testing
These tests can include tensile strength testing, burst testing, and puncture resistance testing.
Documentation and reporting
Test reports and compliance documentation are compiled to detail procedures, results, and conclusion of tests along with compliance to all regulatory standards.
Review and approval
A quality assurance review is conducted to affirm that all criteria have been met, and documentation is submitted to regulatory bodies.
Package validation testing is vital to ensure integrity of a 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 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
Life Science Outsourcing follows ISO 11607 comprehensive guidance on packaging for terminally sterilized medical devices, which includes design, testing, and validation testing requirements.
As an FDA-registered and ISO 13485-certified contract manufacturing organization, Life Science Outsourcing (LSO) offers assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design. Our unique business model combines comprehensive in-house services and extensive regulatory expertise, allowing us to provide the agility and flexibility needed to expedite market launches while standardizing the supply chain and minimizing risks.
Comprehensive packages for regulatory compliance.
From fractional to full cycles with EtO residual testing.
Secure with 2X qualification.
Tailored to your sterilization needs.
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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