A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
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Cover Story

Packaging Testing For Medical Devices

Distribution Simulation Testing

The medical packages encounter many variables during the transit from the manufacturing site to the sterilization facility, distribution center, health care facility, etc. Distribution Simulation is large and quintessential component that complies with the standard and are of three types (Figure 4); Drop test, Vibration test and Compression test. It is necessary to expose the packages and products to atmospheric conditioning in order to simulate particular field conditions that a packaged product or component may encounter during its expected life cycle.


Drop test study is used to determine the package ruggedness nature and interior cushioning effectiveness when the products/ packages systems are exposed to bumpy situation during material handling operations. Vibration study as per ASTM D7387 is used to determine the package withstand to the stresses, shock and vibration that will be encountered during the transit and package’s ability to function and protect in real world conditions.

Compression study as per ASTM D642 is to determine the maximum resistance of compression and lock term stacking strength of the packages (Figure 7). For example, foam is compressed to determine how well it maintains its cushioning properties.

 

Stability Testing/ Shelf Life Testing

Accelerated Aging is a testing method used to estimate the product lifespan when actual data is unavailable or have not gone through the entire product lifespan cycle. A product can be released to market based upon successful Accelerated Aging of the package/product that simulates the period claimed for product expiration (1 year, 2 years, etc). Accelerated Aging data is recognized by regulatory bodies as an acceptable means to generate data quickly, but is only accepted until those tests can be repeated on “real time” samples.

Accelerated Aging test is carried out by subjecting the product to unusually high levels of stress (rapid, but controlled, changes in temperature, humidity, pressure, strain, etc.) designed to mimic the effects of normal use.

Real-Time Aging provides the actual data to determine shelf life and the effects of aging on materials. The test is conducted by placing the test item on a shelf and allowing it to be exposed to typical storage conditions. However this test isn’t feasible in today’s market conditions in which products become obsolete in a short time, and there is a need to shorten the product turnaround time. Time spent sitting on the shelf could prevent lifesaving devices from helping patients in need or it could render the device obsolete before it reaches the market.

Conclusion

In packaging medical products that impact lives and health, the costs of poor quality control can be enormous. In today’s fast moving global markets, the stakes are higher than ever. As competition and time pressures have grown, the industry and its regulators have come to recognize that traditional testing methods can be slow and potentially risky. Package integrity testing has been acknowledged to be an important tool for ensuring the safety of package systems and the products they protect. UL testing and validation services are based on ISO 11607-1:2006 and ASTM standards are designed to assure compliance with FDA, ISO, EN and CE Mark requirements.

References

1. ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices; Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems

2. ASTM D999 – 08, Standard Test Methods for Vibration Testing of Shipping Containers Contributing Author: Divya Ganapathy, Technical Consultant – UL

Divya is a Technical Consultant – Medical Device Regulatory Services representing India. She has over eight years of experience in Regulatory Affairs, and specializes in U.S. FDA 510(k), EU CE Marking for Medical Device and IVD directive, Risk Management, Preclinical, Clinical and Biocompatibility studies as per ISO 10993. She holds a bachelor’s degree in regulatory affairs, master’s degree in microbiology and certified lead auditor for ISO 13485. She is also trained in GMP compliance for the pharmaceutical and medical device sectors. She is trained in medical device Packaging testing at ULMDT, Ochsenhausen, Germany.

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