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About Evaluating Microbial
Barrier Qualities of Medical Device Packaging
Medical device packaging
requirements include all aspects of device packaging, including
labelling, sterilization, and package materials. Microbial
challenge testing plays a crucial role in the assessment of
medical devices and pharmaceutical packaging. Its primary
objective is to determine the packaging’s ability to prevent the
entry of microorganisms, thereby maintaining the sterility and
integrity of the products throughout their lifecycle.
ASTM F1608-16 "Standard Test Method
for Microbial Grade of Porous Encasement Materials (Exposure
Chamber Method) " is used to determine the passage of airborne
bacteria through porous materials intended to Encasement sterile
medical apparatus. This test method is designed to test materials
under test conditions that result in detectable passage of
bacterial spores.
Maintenance of sterility in a
specific packaging application depends on many factors, including
but not limited to the following:
1. Bacterial challenges (number and
type of microorganisms) encountered by the packaging during
distribution and use. This may be affected by factors such as
shipping method, expected shelf life, geographic location and
storage conditions.
2. Packaging design, including
factors such as: adhesion between materials, presence of secondary
and tertiary packaging, and the nature of the equipment within the
package.
3 Rate and volume exchange of air
encountered in porous packaging during distribution and storage.
This can be affected by factors including the amount of free air
within the package and pressure changes due to transportation,
handling, weather or mechanical influences such as room door
closures and HVAC systems.
4. Under different airflow
conditions, the microstructure of porous materials will affect the
relative ability to adsorb or retain microorganisms or both.
The ASTM F1608 method was designed
to compare and rank materials. To detect differences in barrier
performance, a high flow rate was included to create ingress
through materials not seen under real world conditions. Any spores
that penetrate the material are captured on a filter and
enumerated. The log reduction value (LRV) is calculated by
comparing the log of the positive control (no material) to the log
of the test result.
One source of published data on LRV
values shows that medical grade papers typically demonstrate 1-3
LRV, whereas high-density polyethylene options normally fall
between 4-6 LRV.
(https://www.packagingdigest.com/medical-packaging/what-is-the-minimum-acceptable-lrvfor-
medical-packaging-36124).
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