Medical Device Packaging: Overcoming Temperature, Humidity & Altitude Challenges
Medical devices and medical device packaging systems face environmental stresses during distribution that can significantly impact their functionality and safety. Fluctuating temperatures, varying humidity levels, and changing elevations pose challenges that, if unaddressed, may lead to severe issues.
By conducting rigorous medical device packaging testing in temperature, humidity, and altitude chambers, companies can simulate real-world conditions to identify potential vulnerabilities in their products and packaging during development and prevent delays in getting their product to market. Adhering to established industry standards such as ASTM D4332, ASTM D4169, ASTM D6653, ISTA 3A and 3B, 4A, and 4B ensures that medical device and pharmaceutical products remain effective and intact throughout the distribution process, safeguarding their quality.
Distribution Environment Atmospheric Testing
WESTPAK offers a range of tests and chamber sizes to simulate the effects of temperature and humidity fluctuations and air pressure changes in the distribution environment on medical devices and pharmaceutical packaging materials to ensure compliance with medical device packaging requirements:
1. Temperature and Humidity Conditioning
Overview:
This testing exposes medical devices and their packaging materials to conditions they may encounter in the shipping and distribution environment.
Temperature and Humidity Test Examples:
- ASTM D4332: -30°C, 40°C / 90% RH, and 60°C / 15% RH
- ISTA 3A and 3B: +38°C / 85% RH
Purpose of Testing:
- Simulated Shipping and Distribution Conditions: These tests ensure medical device packaging designs and products are exposed to real-world environmental factors before transit testing starts, preventing false confidence in product safety during transportation.
Example Protocols:
- ASTM D4332: This standard provides guidelines for conditioning packages under specific temperature and humidity levels to simulate environmental exposures.
- ISTA 3A and 3B: These procedures are part of the International Safe Transit Association’s testing protocols and focus on performance testing for packaged products in small parcels (3A) and unitized loads (3B), including drops, vibrations, temperature, and humidity changes.
- ISTA 4A and 4B: These protocols offer enhanced simulation testing for less-than-truckload (LTL) shipments (4A) and palletized shipments (4B), replicating real-world distribution conditions to evaluate medical device packaging durability.
2. Altitude Testing
Overview:
Simulates altitude testing for pharmaceutical and medical device packaging by replicating reduced atmospheric pressure conditions, such as those encountered during ground or air transport. This is achieved by lowering the pressure inside an altitude test chamber to evaluate the performance and integrity of the packaging under high-elevation environments.
Simulated Altitude Example:
- 4,267 m [14,000 ft] for one hour: As most commercial aircraft are pressurized to 2,438 m [8,000 ft], this test would cover those scenarios in addition to mountain passes and unpressurized feeder aircraft at lower elevations.
Purpose of Testing:
- Simulated Reduced Air Pressure (Altitude) Conditions: The tests are designed to simulate the low-pressure environments that packaging might experience during transportation at high altitudes, particularly in aircraft and trucks crossing mountain passes.
- Package Integrity: Ensure that packaging and its contents can withstand pressure changes without seal failure or rupture, maintaining product integrity throughout transportation.
Example Protocols:
- ASTM D4169: This is a comprehensive standard for testing the performance of shipping containers and systems. Altitude testing is part of a broader set of simulated distribution environment tests, including drops, vibrations, and temperature changes.
- ASTM D6653: This standard explicitly addresses testing packaging under reduced pressure to simulate high-altitude conditions, focusing on assessing the integrity of the package and its ability to maintain product protection under specific stresses.
Conclusion
WESTPAK provides a comprehensive range of pharmaceutical packaging testing services that simulate the effects of temperature, humidity, and altitude fluctuations on medical devices and their packaging materials. The ISO 17025-accredited testing conducted in our ISTA-certified labs ensures your products remain safe, effective, and compliant throughout the shipping and distribution process.