What Is Packaging Validation?
Packaging validation is an important step in our medical device testing which ensures the safety and durability of the packaging for medical devices by maintaining sterility up to the expiration date. Packaging validation is a total process involving the identification and control of materials and processing variables that affect the ability of a packaged device to meet its acceptance requirements. International standards, such as ISO 11607-1, provide a testing framework to ensure the effectiveness and safety of packaging.
Packaging validation includes design and material selection to the final product distribution. Our packaging validation ensures that storage and transportation packaging comply with regulatory standards.
The different pillars in packaging validation can be summarised as follows:
What Packaging Validation Services Do We Offer?
We offer comprehensive packaging validation services to test packaging solutions. These services are major test methods according to NF EN ISO 11607-1 standard and are critical for the certification of packaging for medical devices. In an accredited environment (ISO 17025)
The very first step is to determine the validation plan according to our customer requirements and support in the selection of worst cases, the sampling requirements and the protocol of tests that needs to be performed.
Packaging Integrity Validation
- Visual Inspection of Seals according to ASTM F1886. We provide visual inspection of seals according to ASTM 1886 standard. This involves the close examination of seals(this might be completed by a visual inspection of the entire packaging) in order to spot any potential sealing or packaging defects.
- Manual Peeling and Seal Strength Tests according to the NF EN 868-5 and/or ASTM F88/88MWe conduct rigorous testing methods for evaluating the manual peeling and seal strength of medical packaging materials. We perform these tests
- Seal Peelability - NF EN 868-5 Annex E: Seal peelability testing involves a visual inspection of the seal and seal width measurement after peeling
- Strength of Sealings - NF EN 868-5 Annex D and ASTM F88/88M: Sealing strength assessments are evaluated with a tensile extensometer. The average peeling force and maximum peeling force are measured during this test.
- Integrity Testing by Dye Penetration according to ASTM F1929 or F3039: We perform dye penetration tests on both porous and non-porous packaging materials in order to detect leaks in the sealing.
- Integrity by Gross leak (bubble test) according to ASTM F2096: The test involves inflating the medical packaging to a predetermined pressure under water in order to detect any leak in the whole packaging (both sealing and material).
Packaging Validation and Stability Testing
In addition an important step in the validation of the packaging is to determine its shelf life and its stability over it.
We provide natural and accelerated aging tests to determine the shelf life and expiry dates of medical devices. These dates are typically 2 to 3 to 5 years and we test both the accelerated (ASTM F1980 standard ) and natural ageing conditions to validate the packaging’s integrity after aging. Similarly to initial packaging validation, the integrity of the packaging is verified after ageing.
Transport Tests Simulation
Transport test simulation is a critical validation step used to ensure that medical packaging is maintained over shipping worldwide. We test according to two standards: the ASTM D4169 standard and the International Safety Transport Association (ISTA) programme.
What Are the Advantages of Packaging Validation?
Packaging validation is essential for making sure the packaging material for your medical devices is secure and conforms to regulatory requirements. Packaging validation has important advantages for clients since it means that your product is fully certified and able to enter the marketplace. These advantages include the following:
- Performance and Reliability: Our packaging validation ensures the integrity of your medical device's packaging under various environmental and logistical conditions throughout its lifecycle. This is critically important to ensure that when patients receive the product, it functions exactly as intended, without any issues caused by packaging faults.
- Patient Safety: Effective packaging validation tests the packaging's ability to prevent contamination and physical damage, thereby protecting the medical device from failures that could pose a safety hazard to patients. Particular attention is given to the strength of the seals and barrier properties to eliminate risks of leaks and contamination penetration.
- Compliance with Regulatory Requirements: By adhering to strict regulatory standards, our packaging validation process not only ensures compliance with legislation but also enhances consumer confidence. Demonstrating that product packaging can effectively protect it throughout its lifecycle bolsters consumer confidence in its safety and efficacy
- Risk Minimisation: Packaging validation identifies risks such as packaging degradation, breaches in sterile barriers, and the potential for physical damage during transport. By identifying these issues, necessary adjustments can be made to enhance packaging robustness, ensuring that the product withstands the rigours of transportation and storage without compromising safety or performance.
- Market Access: Adhering to international packaging standards broadens the market access of your product. Certified reliable packaging allows for the safe transportation and storage of your medical device in various regions, thereby expanding your global presence and market potential.
Why Choose Applus+ Laboratories for Packaging Validation?
Choosing Applus+ Laboratories for your package validation aligns you with a distinguished leader in medical device testing. Our services, compliant with ASTM, ISO and ISTA standards, are specifically crafted to guarantee the structural integrity and safety of your medical device packaging.
- Fully equipped recent lab with the latest technologies
- Strong skills expertise on packaging
- Recognised and certified laboratories and employees
With operations across multiple countries, Applus+ Laboratories brings our leading-edge packaging validation testing services to clients worldwide, ensuring accessibility to superior testing solutions wherever you are located.
Choose Applus+ Laboratories as your trusted advisor and partner in medical device packaging testing. Our commitment to providing high-quality services and expert guidance is designed to streamline your path to market while navigating the complexities of packaging validation with confidence and precision.