Medical Device Package Testing
Keystone Package Testing provides comprehensive medical device packaging services designed to support manufacturers throughout the product lifecycle. As one of the experienced medical device testing laboratories in the industry, we offer proven medical device packaging solutions that evaluate package integrity, sterility maintenance, and transportation durability.
From individual cartons to full pallet configurations, our testing capabilities address vibration, shock, compression, temperature, and humidity to ensure packaging performs as intended during distribution. Our integrated testing approach helps manufacturers reduce risk, improve compliance, and confidently bring products to market.
Ready to get started? Request a quote to see why so many pharma companies partner with Keystone Package Testing. Contact us to receive more information on medical device package testing. Keystone’s capabilities extend beyond packaging testing; we can also conduct EMC/EMI, shielding effectiveness, safety certification, global market access, mechanical and climatic testing for medical devices.
Summary of Medical Device Package Testing
In addition to the crucial EMC (electromagnetic compatibility) testing that medical devices must undergo to ensure they function properly in electromagnetic environments, it is equally important to assess their safety during transportation. This makes medical device package testing a critical step in ensuring safety, compliance, and performance throughout the distribution cycle.
Medical devices are typically high-value items and often fragile. As a result, they must withstand the rigors of transit to ensure they arrive intact. Furthermore, many of these devices are sterile, and maintaining their sterility throughout the transportation process is critical for patient safety.
To address these concerns, manufacturers should implement rigorous testing protocols for transportation safety. Keystone specializes in tests specifically designed to ensure the safe transport of medical devices. Our comprehensive approach includes validating the device packaging to withstand various conditions, thereby assuring that the devices can safely fulfill their lifesaving roles once they reach healthcare providers and patients.
Lastly, for medical devices, ISO 11607 specifies package validation testing. This set of standards includes several key tests to ensure the integrity of the packaging throughout the distribution cycle.
Why is Medical Device Package Integrity Testing Important?
Medical devices are exposed to repeated mechanical, climatic, and handling stresses throughout distribution. Also, medical device performance testing evaluates how well packaging protects devices under these predictable conditions, while medical device reliability testing ensures consistent package performance over time.
Beyond simply protecting the device, packaging must also facilitate ease of use during the point of care. As a result, testing ensures that the packaging can be easily opened and that the device can be accessed without compromising its integrity, keeping user experience in mind.
From manufacturer to end-user hospital, doctor’s office, patient, etc., a medical device will undergo stresses throughout the distribution process. In turn, package testing will test the ability of a package to withstand the predictable stresses it will encounter throughout distribution.
Product Integrity and Safety
- Medical devices are sensitive and delicate products requiring careful handling and protection during transportation.
- Proper testing ensures that the packaging protects the devices from physical damage, temperature variations, and humidity.
- This safeguards the product’s package against other environmental factors that compromise its integrity and safety.
Compliance with Regulations
- Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe, impose strict requirements for medical device packaging.
- Testing is essential to ensure compliance with these regulations. These regulations are designed to safeguard patients and healthcare providers.
Risk Mitigation
- Transportation-related damages can lead to financial losses for manufacturers and distributors.
- If a medical device’s packaging fails during transit, it could result in product recalls, delays in patient care, and potential harm to patients.
- Adequate testing helps identify potential weaknesses in the packaging design and allows for necessary adjustments before the devices reach the market.
Cost-Effectiveness
- Identifying and addressing package integrity issues before mass production and distribution can save significant costs associated with potential recalls, replacements, or legal liabilities resulting from transportation-related damages.
- As shipment volumes increase, even minor packaging failures can translate into substantial annual losses. Without clear data, it’s difficult to understand the full financial impact. Keystone has created a packaging cost/damage tool to help manufacturers understand the repercussions of faulty packaging.
Common Medical Device Package Testing Types
Medical device packaging must meet strict medical device packaging standards to ensure safety, sterility, and regulatory compliance. International and domestic medical device packaging requirements are designed to protect products throughout storage, shipping, and handling while maintaining usability at the point of care.
Accelerated Aging
Accelerated aging, in contrast to real-time aging, serves to demonstrate the integrity and sterility of packaging systems over a period of time. This process involves subjecting packaging materials to environmental conditions that simulate the effects of aging but at a substantially faster rate. By doing so, manufacturers can quickly assess how well these systems will perform over the long term.
For more information on accelerated aging testing, please visit the links below:
Bubble Leak / Dye Penetration
The purpose of bubble leak and dye penetration testing is to detect gross leaks in packaging.
Regarding sterilization of the medical device, one of the most common test standards is the ASTM F2096 also known as the Bubble Test. This test measures the material integrity of the package and is performed by submerging the package under water and increasing the internal pressure of the package.
Cold Chain
Cold chain package testing is used to measure the effects of temperature and humidity on packages. ISTA 7D shipping tests can be used for the development of temperature-controlled transport packages made of any material. IEC 60601 applies to medical equipment in the home healthcare system
For more information on cold chain package testing, please follow the link below:
Seal Strength
Seal strength testing evaluates the strength of seals in flexible barrier materials and terminally sterilized medical devices. This type of testing pertains to opening force and package integrity. Not only does seal integrity testing cover the strength of seals but it also evaluates the manufacturer’s packaging process, and their ability to produce consistent seals.
ASTM F88 measures the force required to separate a test strip of material containing the seal.
Expert Medical Device Packaging Validation Test Lab
Companies partner with Keystone because we operate as a full-service medical device testing laboratories organization, delivering accurate testing, clear reporting, and dependable turnaround times. Our experience across packaging, environmental, and regulatory testing allows manufacturers to work with a single trusted partner for compliance and quality assurance.
The information listed below are most commonly used for medical devices to ensure safety and sterilization throughout the distribution process. If you are looking for a specific test that you do not see on this list, please search our site for that standard or request a quote.
- ASTM D4169: Ship Testing
- ASTM F88: Seal Strength Testing
- ASTM F1140: Burst and Creep Testing
- ASTM F1929: Leak Testing
- ASTM F1980: Accelerated Aging Testing
- ASTM F2054: Burst Testing
- ASTM F2095: Leak Testing
- ASTM F2096: Leak Testing
- ASTM F3039: Leak and Dye Testing
- ISTA 7E: Temperature Testing
- ISTA 7D: Temperature Testing
- ISO 11607: Medical Device Testing
Please contact us or request a quote if you are ready to start your regulatory compliance testing. We look forward to working with you.
Interested in the EMC/EMI, climatic, dynamic, shielding effectiveness, or IP Code testing of a product? Follow the corresponding links or www.keystonecompliance.com for more information.