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Sterile
Packaging: The Facts Of Shelf Life
Commercial introduction of new
products carries with it the challenge of assigning to
them an effective shelf life, as well as ensuring that the
packaging chosen for them is appropriate for the intended
sterilization, transportation, storage and end use.
Accelerated Ageing
Protocols
Understanding the impact of
time on the efficacy of a sterile medical device often
relies on accelerated ageing protocols. Such protocols are
generally accepted as valid for testing new product
introductions, provided real-time ageing is in place to
confirm accelerated ageing test results. Devices are
generally regarded as sterile as long as package integrity
has not been compromised.
Typically, during ageing
studies, a series of tests are carried out to assess
package integrity and the physical properties of the
packaging materials. Packages that have been sterilised
and aged in this manner are then sometimes subjected to
shipping studies. It is helpful to divide these different
approaches into two categories: accelerated ageing, where
the effects of time on packaging and its contents are
being studied, and environmental challenging, where
extremes of temperature and/or humidity are simulated to
determine the impact of difficult environments on
packaging systems.
Making Material Selections
Different materials have
different sensitivity to moisture, so conclusions
regarding a given material’s suitability as a packaging
component may not be valid if humidity is not
controlled. For example, paper is particularly sensitive
to humidity. Excessive drying negatively impacts its
strength properties, and excessive humidity can lead to
mould growth. Some laminates commonly employed in medical
packaging may fail under conditions of extreme humidity.
Ultimately, the medical device
manufacturer must make the final decision regarding the
suitability of a packaging material to ensure the efficacy
of a sterilized medical device.
(Ref:
http://www.sterilizationpackaging.org/news/spmc-articles/archives/2006/03/01/sterile-packaging-the-facts-of-shelf-life/)
Packaging Trends For Biologics
As the trend toward
self-administration continues, the need for careful
consideration of primary container packaging design and
interaction with biologics, devices, and the patient
becomes more critical.
Over the last several years,
biologics recalls have increased due to quality issues,
including fundamental weaknesses in primary glass
containers that have resulted in problems such as breakage
or delamination. The pace continued in 2012 with recalls
of 19 lots of four different injectable oncology products
caused by the discovery of glass particles.
As home injection trends rise,
pharmaceutical/biologic and packaging manufacturers must
concentrate not only on how the biologic reacts with its
primary container, but also how the container interacts
with the delivery device, and finally, how the patient
interacts with the assembled system.
Issues, particularly breakage
of primary containers, have been reported that have
resulted in recalls when either the primary The primary
standard governing medical device packaging and shelf life
validation is ISO 11607-1. The intent behind this standard
is “To provide designers and manufacturers of medical
devices with a framework of laboratory tests and
evaluations that can be used to qualify the overall
performance of the package used to protect the device
components during handling, distribution, and storage.”
ISO 11607 details the
requirements from the International Organization for
Standardization (ISO) for this process. The standard is
broken into two parts. Below is a summary of each of the
two sections of the standard.
ISO 11607-1 details the
elemental attributes demanded of materials and pre-formed
systems intended for use in packaging systems for
terminally sterilised medical devices. It takes into
consideration the vast array of potential materials,
medical devices, packaging system designs, and
sterilisation methods.
ISO 11607-2 describes the
validation requirements for forming, sealing and assembly
processes. The development and validation of packaging
processes are crucial to ensure that sterile barrier
system integrity is maintained until opened by the users
of sterile medical devices.
Beyond ISO there are also ASTM
(Association for Testing and Materials) and ISTA
(International Safe Transit Association) standards which
must be followed, especially if you intend to achieve FDA
(Food and Drug Administration) approval.
(Ref:
http://lso-inc.com/medical-package-testing/)
ISO 11607:
Package Validation Test Standard
The primary standard governing medical device packaging
and shelf life validation is ISO 11607-1. The intent
behind this standard is “To provide designers and
manufacturers of medical devices with a framework of
laboratory tests and evaluations that can be used to
qualify the overall performance of the package used to
protect the device components during handling,
distribution, and storage.”
ISO 11607 details the requirements from the International
Organization for Standardization (ISO) for this process.
The standard is broken into two parts. Below is a summary
of each of the two sections of the standard.
ISO 11607-1 details the elemental attributes demanded of
materials and pre-formed systems intended for use in
packaging systems for terminally sterilised medical
devices. It takes into consideration the vast array of
potential materials, medical devices, packaging system
designs, and sterilisation methods.
ISO 11607-2 describes the validation requirements for
forming, sealing and assembly processes. The development
and validation of packaging processes are crucial to
ensure that sterile barrier system integrity is maintained
until opened by the users of sterile medical devices.
Beyond ISO there are also ASTM (Association for Testing
and Materials) and ISTA (International Safe Transit
Association) standards which must be followed, especially
if you intend to achieve FDA (Food and Drug
Administration) approval.
(Ref:
http://lso-inc.com/medical-package-testing/)
Packaging Market For Disposable
Medical Devices: Report
Packaging market for
disposable medical devices will reach more than US$4.0
billion by 2016. This 450 page study examines the drivers,
trends, and forecasts for the key technologies used in
this market. It includes a special section covering the
regulatory environment as it relates to package
development.
(Ref: For More Details,
visit:
http://www.packstrat.com/ext/resources/PS/Home/Files/PDFs/Medical_Device2012_Brochure.pdf)
Medical Package Testing
1. Distribution Simulation
Testing - Involves a series of tests specifically
designed to measure the sturdiness of the outer/secondary
packaging. This is to ensure that the packaging can meet
industry standards and can safely contain the devices
during shipping, handling and storage. Major standards
involved are:
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ISTA-1A: Non-Simulation
Integrity Performance Tests
-
ISTA-2A: Partial Simulation
Performance Tests
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ISTA-3A: General Simulation
Performance Tests
2. Package Integrity
Testing - Focuses on the device’s primary
packaging/pouch. Tests are designed to check the pouch’s
ability to maintain sterility and its robustness.
Standards utilized are:
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ASTM F2096: Bubble Leak Test -
Standard test method for detecting gross leaks in
packaging by internal pressurization
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ASTM F88: Peel Strength Test -
Standard test method for seal strength of flexible barrier
materials
-
ASTM F1140: Burst Test -
Standard test methods for internal pressurisation failure
resistance of unrestrained packages
-
ASTM F1929: Dye Penetration
Test - Standard test method for detecting seal leaks in
porous medical packaging by dye penetration
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ASTM F1886: Visual Inspection
Test - Standard test method for determining integrity of
seals for medical packaging by visual inspection
3. Stability
Testing/Accelerated Ageing - Includes accelerated
ageing and real-time ageing. Tests are conducted to
determine packaging configuration efficiency to maintain
product sterility for the intended shelf life period.
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ASTM F1980:Standard Guide for
Accelerated Aging of Sterile Barrier Systems for Medical
Devices
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ASTM D4332: Standard Practice
for Conditioning Containers, Packages, or Packaging
Components for Testing
(Ref:
http://lso-inc.com/medical-package-testing/)
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