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					                            Package Integrity Test Methods
                                        Patrick J. Nolan
                                           DDL, Inc.


Introduction
The package for a medical device plays a key role in safely delivering specialized
treatment to the patient for which the device was designed and developed. It must
ensure the efficacy of the device from the point of manufacture to the point of final use.
Most single use terminally sterilized medical devices must be delivered with a very high
confidence that the device has remained in a sterile condition throughout its storage,
handling and transport environment. In addition, packaging may have a direct function
in the application of the treatment, as it may act as a fixture or dispenser to the
physician. Thus mechanical damage to the package may not be tolerated. The design
and development of the packaging system has come under closer and closer scrutiny
by both the international and domestic regulatory agencies. This scrutiny has placed a
great deal of emphasis on standardizing the package development process. Some
standardization of the packaging process has come in the form of the international
standard entitled ISO 11607; Packaging for terminally sterilized medical devices. This
paper will specifically discuss the current consensus (ASTM) and industry test methods
available for evaluating the integrity of packages.


Package Integrity vs. Package Strength
First, there seems to be some confusion within the medical device industry regarding
the strength of a package versus the integrity of a package. Package strength concerns
the force required to separate two components of the package. It could be the force to
separate two flexible components of a pouch, or a flexible lid and a thermoform tray.
These forces may be measured in pounds per inch width, as in the seal/peel test; or in
pounds per square inch, as in the burst test method. Alone, these tests of package
strength values do not necessarily prove the integrity of the entire package. For
example, since the seal/peel test per ASTM F 88 only evaluates a one-inch segment of
the package; there may be other areas of the package, which are not sealed adequately
to prevent contamination of the product. In fact, the seal width that was actually
measured may be within the strength specification but may have a channel leak that
could breach the package and negate integrity.


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Likewise, the ASTM F 1140 burst test method as referenced by ISO 11607 also has its
pitfalls. This method evaluates the whole package by applying pressure to all areas of
the package, however the pressure is not applied equally at all points due to package
irregularities and distortions. This can lead to a relatively high degree of variability
between tests. Further, the burst test may not detect breaches in the package, such as
pinholes and channel leaks, even though the burst test values have met the
performance specification.


Even though the package strength specifications are confirmed, the package integrity is
not necessarily proven. Package integrity is defined by ISO 11607 as, unimpaired
physical condition of a final package. Seal integrity is defined as, condition of the seal
which ensures that it presents a microbial barrier to at least the same extent as the rest
of the packaging. Neither definition refers to the strength of the seal.    Package
integrity is independent of package strength, although a strong package seal is a
convincing indicator of a safe package. Further, if the entire seal area is proven to be
homogeneous and continuous, then one could say that the package seals provide
integrity. However, this says nothing about the package surfaces which may have
pinholes or leaks not detected by seal strength tests. Other mechanical tests may be
appropriate for determining package seal homogeneity.


So, seal strength is important in the over-all scheme of developing the package
process, but the seal strength performance specification is used most effectively to
monitor the process, not to determine ultimate acceptance. Seal strength is also an
important determinant for establishing package process parameters. In fact the ISO
11607 standard requires that the seal strength shall be determined at the upper and
lower limits of the defined critical sealing process variables and shall be demonstrated
to be suitable for the intended purpose. To restate, seal strength is an important
performance attribute for the package and provides suitable guidance in establishing
statistical process control limits, but is not the absolute determinant of the acceptability
of the package for its intended use. Package integrity at the point of final use is the
principal acceptance criterion for a sterile medical device package. However, both
performance attributes are essential to the package design and development process.



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Determining Package Integrity
What methods are available to the medical device industry for evaluating package
integrity?

One category of package integrity method has been available for over ten years and
involves microbial challenge and product sterility. As you will read later in this paper,
these are not the only means of determining package integrity and these methods are
coming under tighter examination, as alternate test procedures are developed. In fact,
the FDA has recognized ISO 11607 as a consensus standard which states that, The
manufacturer shall demonstrate the integrity of the package by testing the package.
This can be accomplished by physical tests. Examples of physical tests as described in
the ISO 11607 standard include; internal pressure test, dye penetration test, gas
sensing test, vacuum leak test. All of these methods have their advantages and
disadvantages.




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Conclusion
Package seal strength does not necessarily equate to package integrity. These two
attributes of a finished medical device package are separate considerations in proving
the efficacy of the package. Industry has developed methods for seal strength testing
which are used to validate the package process. Although package seal strength is an
important performance attribute, the ultimate acceptance of the package is based on its
complete integrity. There are several means available for evaluating the integrity of
sterile medical device packages. The application of a particular integrity test depends
upon may factors including the type of package, materials of construction, size, desired
sensitivity, and objective of the test.


References
1. Jones, Lois et.al, In Quest of Sterile Packaging: Part 1; Approaches to Package
   Testing, Medical Device and Diagnostics Industry, August, 1995
2. Jones, Lois et.al, In Quest of Sterile Packaging: Part 2; Physical Package Integrity
   Test Methods, Medical Device and Diagnostics Industry, September 1995
3. Tyvek and SealCheck 210-The Package for Effective, Non-Destructive Testing,
   Tyvek RX Newsletter, January, 1999, Vol. 8, Issue 1
4. Hackett, Earl T., Dye Penetration Effective for Detecting package Seal Defects,
   Packaging Technology and Engineering, August, 1996
5. Nolan, Patrick J., Physical Test Methods for Validating Package Integrity, The
   Validation Consultant, July, 1996, Vol. 3, No. 6
6. Spitzley, John, How Effective is Microbial Challenge testing for Intact Sterile
   Packaging?, Medical Device and Diagnostics Industry, 15(8): 44-46, 1993


For more information about Package Integrity Test Methods please contact DDL at
1.800.229.4235 x115 or e-mail us at srlevy@testedandproven.com




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