Introduction to Medical Packaging Seal Integrity Regulations
When it comes to medical devices, maintaining medical packaging seal integrity is absolutely critical. A single breach in packaging can lead to contamination, which puts patients at risk and may result in product recalls, regulatory violations, or costly litigation. Because of the life-or-death nature of many medical devices, the industry is governed by strict standards to ensure that packaging remains sterile and secure.
One of the most important of these standards is ISO 11607. This international standard outlines the requirements for materials, design, and testing of packaging used to terminally sterilise medical devices. Whether you’re manufacturing syringes, catheters, medical trays, or wound dressings, complying with ISO 11607 is essential for delivering safe, sterile products.
At Dynascan, we support medical device manufacturers with reliable, high-performance seal integrity testing systems that meet ISO requirements. In this article, we’ll explore what ISO 11607 involves, why seal integrity matters so much, and how you can achieve and maintain compliance.
What is ISO 11607?
ISO 11607 is the global standard that defines how packaging systems for sterilised medical devices should be designed, validated, and tested. It consists of two key parts:
- ISO 11607-1: Requirements for materials, sterile barrier systems, and packaging systems.
- ISO 11607-2: Guidelines for validation of packaging processes, including forming, sealing, and assembly.
These parts work together to ensure that sterile packaging can protect medical devices through manufacturing, sterilisation, shipping, and storage—all the way until the point of use.
To comply with ISO 11607, manufacturers must prove that their packaging is:
- Made from appropriate, sterile-barrier materials.
- Properly sealed to prevent microbial ingress.
- Able to maintain sterility through its shelf life.
- Tested and validated using proven methods.
Why Seal Integrity Matters in Medical Packaging
Medical packaging seal integrity plays a vital role in protecting patients and healthcare workers. When a sterile device is opened for use, there must be complete confidence that it has remained uncontaminated throughout its journey.
If a package seal is weak, incomplete, or damaged, it can allow bacteria, moisture, or other contaminants to enter. This can lead to serious complications, including infections, treatment failures, and delayed procedures.
Packaging defects can occur for many reasons:
- Inconsistent sealing temperatures or pressures.
- Contamination at the seal area during manufacturing.
- Damage during handling, transport, or storage.
- Poor material selection or manufacturing errors.
To prevent these risks, manufacturers must regularly test packaging and validate their processes to ensure they meet the highest standards.
Key Requirements of ISO 11607 & Medical Packaging Seal Integrity
To be compliant with ISO 11607, manufacturers must meet several important requirements:
- Material Selection: The packaging material must be suitable for maintaining a sterile barrier and compatible with the sterilisation method used (e.g., steam, ethylene oxide, or gamma radiation).
- Packaging Design: The design must be robust enough to withstand handling and transportation without breaking the seal or damaging the contents.
- Seal Integrity and Strength: Seals must be uniform, strong, and resistant to environmental stresses. They should not peel open prematurely or tear unevenly.
- Process Validation: Sealing equipment and processes must be validated to ensure repeatability and control. This includes documenting sealing parameters like temperature, pressure, and dwell time.
- Routine Testing and Monitoring: Regular seal integrity testing must be performed to ensure ongoing compliance and detect issues early.
By meeting these requirements, manufacturers demonstrate that their packaging consistently maintains sterility, quality, and performance.
How to Ensure Compliance: Dynascan’s Approach
Dynascan offers practical, reliable solutions to help medical manufacturers meet ISO 11607 requirements. Here’s how our systems support compliance at every stage.
1. Perform Accurate Package Integrity Testing
Our systems offer both non-destructive and destructive testing methods to ensure your packaging is free from leaks and weaknesses.
- Vacuum Decay Testing: This non-destructive test identifies micro-leaks by measuring pressure changes in a vacuum chamber. It’s highly sensitive and ideal for packaging that must remain sterile after testing.
- Bubble Emission Testing: Packages are submerged in water and pressurised. If bubbles appear, there’s a leak. This method is ideal for trays, blisters, and pouches.
- Seal Strength Testing: This destructive test checks how much force is needed to pull a seal apart. It confirms that seals are strong enough to protect the contents throughout the product’s lifecycle.
These methods are suitable for a wide range of packaging formats, including peel pouches, medical blisters, implant packaging, contraceptive devices, syringes, and diagnostic kits.
2.Validate and Monitor Packaging Processes
Validation ensures that your packaging line consistently produces sterile, well-sealed packaging. With Dynascan systems, you can monitor key parameters such as:
- Seal temperature
- Sealing pressure
- Dwell time
By logging this data, manufacturers can demonstrate process consistency and quickly identify deviations.
We also support performance qualification and installation qualification, helping you document every step of your validation process.
3. Use ASTM-Compliant Testing Methods
Regulators often require that testing be performed using recognised standards. Dynascan systems support multiple ASTM-compliant methods, including:
- ASTM F88 – Seal strength testing
- ASTM F2338 – Vacuum decay testing
- ASTM F2096 – Bubble emission testing
Using standardised methods helps ensure your data is credible and comparable. It also simplifies the approval process when working with international regulatory bodies.
4. Customise Testing for Specific Devices
Different devices need different types of packaging, and no single solution works for all. We offer both off-the-shelf systems and fully customised solutions that fit your exact product and packaging configuration.
Whether you’re testing rigid trays, flexible peel pouches, or specialised kits, Dynascan will tailor the testing system to meet your needs. This ensures efficient, accurate testing that reflects real-world conditions.
5. Maintain Records and Documentation
ISO 11607 requires clear and traceable documentation for all validation and testing activities. Our systems are designed to log data automatically, store test results, and generate detailed reports.
This makes audits easier and ensures you can quickly provide evidence of compliance. Digital records also support trend analysis and continuous improvement over time.
Why Work With Dynascan For Medical Packaging Seal Integrity Testing?
Dynascan is a trusted partner in the medical packaging industry. Here’s what sets us apart:
- ISO 9001 accredited manufacturing ensures our products are built to the highest quality standards.
- Broad industry experience, supporting manufacturers across anaesthesiology, surgery, neurology, cardiology, and more.
- Flexible solutions, including standard products and fully customised systems.
- Responsive support, from consultation and design to installation, training, and after-sales service.
Whether you’re a high-volume manufacturer or a niche supplier, we provide solutions that help you stay compliant and deliver safe, sterile products.
Recap
Ensuring medical packaging seal integrity is critical to protecting patient safety and meeting regulatory standards. ISO 11607 provides the framework, but it’s up to manufacturers to implement reliable processes and testing procedures.
By working with Dynascan, you gain access to advanced testing technology, expert support, and solutions tailored to your needs. From validating your packaging line to performing daily integrity tests, we help you meet ISO 11607 with confidence.
Contact us today to speak with a specialist or request a free test report to assess your current packaging performance. Let’s work together to keep your products compliant, reliable, and safe.
