Back
to TME Resources List
ASTM
and ISO 11607 Information
ASTM
Reference F1140-88
Package Validation for ISO para 4.1.5; 4.1.6.2
Final Testing, ISO para. 6.3.2
As
many of you know, there is a guiding document
for the methods of Burst and Creep tests. Since
1988 ASTM 1140-88 has described the basic methodology
for testing in the Unrestrained package form.
This document has been relatively brief without
precision and bias information. Last month the
ASTM subcommittee has completed work on an updated
and more complete method description that will
be published on its final approval by ASTM.
Other
methodologies for the Burst and Creep test are
being used in the industry. The Restrained burst
and creep test are used by several pouch and blister
users. In this method, two ridged restraining
plates hold the package on each side. These plates
prevent the package from taking the balloon shape
and provide a constant angle of pressure application
at the seal. This method is said to supply more
repeatable values due to the reproducible geometry
at the seal’s point of application of force.
Once again, applying consistent test methods and
minimizing test variables produces better test
results.
ASTM
subcommittees are currently working on defining
new methodologies for restrained Burst and Creep
tests for pouches and blisters. When these methods
are complete, it will enhance the industry’s
ability to produce more precise data with these
tests.
The
recent draft of ISO 11607 has set out a logical
method for the validation, control and final testing
of sterile medical packaging. In this standard
are references to the use of seal strength testing
to provide data in these design and control processes.
Paragraph 4.1.5.c indicates the need to meet a
minimum specified seal strength and paragraph
4.1.6.2 indicates the need to meet the manufacturers
own specifications for burst and or seal strength
values. Paragraph 6.3.2 asks that some consistent
measuring methodology is used to verify package
seal strength and integrity. Burst and Creep tests
are but one of the necessary final test to verify
the quality and integrity of the package.
The
ISO document recognizes that there are good engineering
and manufacturing practices that need to be followed
to design and produce a high quality sterile package.
Among those practices is the measurement of seal
performance. Burst and Creep testing are proven
available technology to meet these goals.
This paper is presented courtesy
of TM Electronics, Inc.
Back
to TME Resources List
|
