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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