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Implications
for Process Package Testing in ISO 11607
-Stephen
Franks, TM Electronics
The
ISO 11607 Standard, Packaging for Terminally Sterilized
Medical Devices, is a guidance document that describes
the process for design, development, validation,
process control and final qualification of packages
used in the protection of sterile medical devices.
Even though this document is pointed specifically
at the manufacturer of sterile medical devices,
it is a well thought out vehicle to guide any
package designer through the complexities of specialized
package production.
The ISO 11607 standard outlines the principal
requirements for packaging process development,
validation and process control for packages that
are intended to protect the internal product.
It describes methods of material qualification,
section 4, process qualification, section 5 and
final package qualification, section 6. In each
of these sections specific reference is made to
methods of testing that help to verify the overall
performance of the package. Some of the paragraphs
that reference these methods are discussed below.
In testing packages for their performance a distinction
must be made between their ability to maintain
a sterile environment and the mechanical performance
properties of the package. The ability to maintain
the sterile properties of the internal product
is called "Integrity". The mechanical
performance is more often referred to a its "
strength". When evaluating the materials
of the package, its "sterile barrier"
properties are examined. The seals of a package,
can be examined for their "seal integrity",
i.e. lack of leaks, or their "seal strength",
i.e. their mechanical strength.
In ISO 11607, section 4.1.5 section "c"
concerning the typical peelable package materials
with adhesive coatings, states that "materials
shall demonstrate a minimum specified seal strength".
This means in the design stage that the producer
must consider the stresses of manufacture, sterilization
and transportation that the package will see during
its lifetime. These stresses should be transformed
into a specification that will prevent package
rupture in its normal life cycle. The implication
for testing is that some quantitative measure
needs to be made to verify this strength value.
Whole package inflation tests such as burst or
creep methods provide this information.
Furthermore, in section 4.1.6.2 the standard specifically
states that "Packages shall meet producer's
and manufacturer's specifications for seal width,
burst and/or seal strength". The implication
for testing is that a quantitative measure is
needed to verify these parameters. The burst seal
strength test provides quantitative results to
meet this need.
Section 4.2.1.1.4 states "Means shall be
provided to ensure that all packaging used in
routine production is within the limits determined
to be suitable for the sterilization process".
The implication for testing is that a quantitative
measure needs to be made to check the strength
and integrity of the package before and after
sterilization. Burst seal strength testing and
leak testing are methods to quantify this need.
Section
5 of ISO 11607 outlines the process qualification
for forming and sealing packages. The intent of
the requirements of this paragraph are set forth
to establish appropriate upper and lower processing
limits during package manufacture. Essential process
controls on such things as sealer temperature,
pressure and dwell must be evaluated and limits
applied. A process verification must be actually
performed to confirm the process limits. Furthermore,
packages made at these limits need to be subjected
to performance testing to prove their capability.
The implication for testing is that a quantitative
measure of the package strength will document
the process limits. Burst, creep or creep to failure
testing provides a quantitative measure of package
strength.
In section 5.4.1 the standard states "Either
during or after the process validation the manufacturer
shall establish procedures to ensure that the
package process will be under control during routine
operation". The implication for testing is
that a fast, easy to use method should be available
to periodically check the performance of the process
while it is running. Burst, creep and creep to
failure testing provides a fast and effective
method to gather quantitative data on the consistency
of the package sealing process.
Final package product test selection must combine
a series of tests to verify that the package will
meet its specified requirements. Section 6 of
ISO 11607 discusses these test methods. This section
indicates that several tests may be required to
confirm the package performance to its specification.
In section 6.3.2.2 seal strength tests are noted
as methods to confirm the critical sealing process
variables, and whether the process is operating
under control. Furthermore, the burst/ creep pressure
tests are noted to evaluate the overall minimum
seal strength of the whole package as tested simultaneously.
The implication for testing is that burst and
creep test methods exist which will provide quantitative
results that document the level of process control
that the manufacturer provides. Clear documented
results in graphic and numerical form or statistical
data on the results are available in the BT-1000
package tester to meet the needs of both ISO 11607
and other regulatory requirements.
Section 6.4.3.3 discusses shelf life of the product.
Artificial and real time aging tests are needed
to verify product and package shelf life. The
implication for testing is that burst and creep
test methods provide quantitative performance
at each life test point.
The TM Electronics, Inc. BT-1000 Automated Package
Tester gives the user a simple, repeatable, reliable
instrument to meet the test requirements of ISO
11607. Furthermore, its built in graphic and SQC
analysis programs provide documented results of
the tests for the packaging process performance.
Contact T.M.E. for complete details on how the
BT-1000 will meet your needs for ISO 11607 testing.
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