Seal Strength Testing

Seal strength testing is a critical quality control measure for peelable medical package seals and a variety of heat-sealed packages, ensuring the integrity and reliability of medical device packaging. This test evaluates the force required to separate sealed surfaces, which is essential for preventing contamination, maintaining sterility, and ensuring product safety throughout transportation and storage. For medical device manufacturers, seal strength testing is not only a key factor in packaging development but also a mandatory requirement for regulatory submissions, including FDA 510(k), CE Marking, and ISO 11607 compliance. By validating seal integrity, manufacturers can minimize the risk of package failure, reduce recalls, and enhance patient safety.

Our Service

5-1-4-seal-strength-testing-1. (Generated by AI)

At Meditronics (a brand of STEMart), we provide precise and reliable seal strength testing in accordance with ASTM F88 and other relevant standards (such as ISO 11607 and ASTM F2054). Our testing ensures that medical device packaging meets industry requirements for durability and performance.

work flow (made by Meditronics)

1. Sample Preparation

A specialized sample cutter is used to extract 1-inch-wide strips from each side of the pouch or package.

2. Testing Setup

The prepared samples are securely clamped into the tensile testing machine, which applies controlled force to separate the seal. The seal strength is measured using three different configurations:

Unsupported peel (direct separation of the seal)
90° supported peel (peeling at a right angle with backing support)
180° supported peel (peeling in a straight line with backing support)

3. Data Collection

The maximum force (in N/15mm or lbf/in) required to break the seal is recorded, along with observations on separation behavior (e.g., clean peel, material tearing, or adhesive failure).

Why Choose Meditronics?

Meditronics is a trusted partner for medical device packaging testing, offering advanced capabilities and industry-leading expertise in seal strength evaluation. Our key advantages include:

✔ Customized Protocol Development

We tailor testing protocols to match specific packaging materials, sterilization methods, and regulatory requirements, ensuring compliance with FDA, EU MDR, and ISO standards.

✔ Reliable, Regulatory-Ready Results

With extensive experience in medical device packaging validation, we help manufacturers prepare documentation for 510(k), CE Marking, and ISO 11607 certification.

✔ Fast Turnaround & Detailed Reporting

We provide comprehensive test reports with clear pass/fail criteria, supporting quick decision-making in packaging development and quality control.

By partnering with Meditronics, medical device manufacturers gain confidence in their packaging's performance, ensuring sterility, durability, and compliance with global regulations.

For more information on our seal strength testing services, contact Meditronics today to discuss your project requirements.

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