Packaging Testing
How
has package testing changed over the past decade - is it simpler or more
complicated?
Package testing has become simpler, more cost-effective and efficient if
the proper test method is applied. High precision non-destructive inspection
technologies coupled with a user-friendly approach have been PTI's focus for
over 20 years.
Most important is the fact that package integrity testing has
become more reliable - a key issue that cannot be overlooked. When talking
about different testing methods for package analysis, the bottom line is
that "reliability" should never be sacrificed for the sake of
simplicity.
Which package testing procedures tend to be the most complicated?
Helium testing is based on complicated technology which also makes it more
expensive, and it can be destructive depending on the type of package and
product. At the other end of the spectrum are water bath, dye tests, peel
and burst tests. These methods are simple to perform, requiring less
expensive equipment, but they are all in fact complicated because of many
factors. These methods are destructive to both package and product, and are
time consuming; producing test results that are dependent on technique,
sample preparation and operator variability. Results from peel and burst
tests can be difficult to interpret or correlate to manufacturing process
parameters, package quality or shelf-life performance. In the end, such
methods can prove to be complicated and very costly due to the collective
expense of waste, mess and loss of product.
How can package testing be simplified, while still meeting FDA and ISO
standards for consistency and reliability?
Methods can be made simpler, more consistent and reliable by following
clear, well-defined procedures. Organizations such as ASTM International
provide test methods that have undergone peer-review and round robin testing
using multiple instruments to demonstrate the reliability of test results.
Following methods that have undergone such scrutiny go a long way toward
improving test techniques. Clearly, there is a growing need for the
development of rapid, non-destructive, non-invasive testing technologies.
Some of the newer methods which address this need include non-destructive
test methods such as vacuum/pressure decay, airborne ultrasound inspection
and also force load testing. These methods are all highly reliable
technologies yielding repeatable, quantifiable statistical test data.
Because they are non-destructive, the same samples can be repeatedly tested,
a greater number of samples can be tested, and even the actual marketed
product itself can be tested. The use of simplified, non-destructive package
testing that can rapidly deliver consistent results can significantly raise
the level of packaging quality control.
Do non-destructive package testing methods make package validation
simpler as well?
Without a doubt, yes - validation is simpler with non-destructive methods
such as vacuum decay or airborne ultrasound. Validation with destructive
methods is time consuming, costly and inefficient due to the lack of
reliable, quantitative test data. Also, using instruments that are
manufactured using only components that are calibrated according to national
(NIST) reference standards is another factor supporting simpler validation.
Are simpler testing methods necessarily less costly and time consuming
to perform?
Often we think of cost based solely on the price of the test instrument.
Test instruments vary greatly depending on the type of test being performed
and the test sensitivity required. However, other factors influence cost,
including time required to perform the test for one, and the loss of
packages from destructive testing, for another. An ideal method would be
rapid, non-destructive and inexpensive. For example, a test cycle on PTI's
vacuum decay leak testers literally takes a few seconds, providing a
pass/fail result. Checking for seal integrity using SEAL-SCAN, our
airborne ultrasonic inspection technology is also a fast, highly efficient
non-destructive method to verify seal quality and pinpoint type, size and
location of seal defects.
Generally, which are more cost-effective - destructive or
non-destructive forms of package testing?
The point is - why destroy perfectly good product or packages to find
defects? Does it make sense to use visual test methods that are entirely
inconsistent and unreliable? Again, many of the destructive methods
mentioned (water, dye, peel, burst) are both complicated for the operator,
yield data that are difficult to interpret, and finally can be very
expensive because of the nature of the product being tested. Plus, you are
still never sure about the quality of packages you market. In the
pharmaceutical and medical device industries, this amounts to significant
dollars that could easily be saved by applying nondestructive technologies
and ASTM International approved testing methods that conform to FDA
recognized consensus standards.
Does inspecting packaging materials rather than just the finished
package simplify or complicate the testing process?
Inspecting packaging materials rather than just the finished package is a
logical and efficient approach. It just makes sense - why fill a defective
package with a costly product, only to discover later on in the
manufacturing process that you have a defect? In fact, for pouch and tray
manufacturers, integrity testing of the package materials before
filling/sealing using an approved test method has been a requirement for
some time.
Can cross-functional testing equipment make it possible to perform tests
on multiple types of products, yet still be simple to operate?
Absolutely, for example with our vacuum decay leak test technology, the
ASTM International has approved test methods for different types of packages
(e.g. flexible, rigid, semi-rigid, and packaging with non-porous and porous
barrier lidding materials such as Tyvek®). Testing different package
types often requires a simple tooling change. We've designed features such
as self-teach that simplify setting up testing criteria for each type of
package - again catering to the operator and helping to increase efficiency
and productivity. Our SEAL SCAN Airborne ultrasound inspection
technology is capable of testing many types of packaging materials, be it
aluminum, foil, paper, Tyvek® or any combination thereof. PTI offers
SEAL SCAN configurations for R&D, quality and process control as
well as 100% on-line inspection, and all use the same principle of
operation.
Is there a trend toward automation of testing or performing tests
in-line?
There is an increased awareness about the importance of package integrity
across all industries, so the pressure is on for companies to invest in
better quality inspection technologies that can be applied for both off-line
testing and in-line automated inspection. Practically speaking, it's
impossible to configure destructive test methods on-line. Companies that
continue to use destructive methods that were developed and approved for use
over two decades ago need to re-evaluate their process and investigate the
technologies that are significantly better, provide valuable data that will
improve their manufacturing process, helping to ultimately reduce overall
costs.
What products exist to help automate and simplify gathering of testing
data?
PTI's vacuum pressure decay and airborne ultrasound are two technologies
that offer highly consistent, repeatable test results with test data that
can be evaluated on its own or easily downloaded into other programs for
further analysis.
Can the sequence in which various tests are performed on a package (i.e.
accelerated aging, seal tests, etc.) impact the simplicity of the testing
process as a whole?
This depends on the equipment and test method being used, destructive or
non-destructive. When using non-destructive testing such as vacuum decay or
airborne ultrasound, testing can be performed in any sequence and even
repeatedly on a single sample, whereas with destructive tests, you are
definitely limited. If multiple tests are required for a package, the
important factor is to keep the quality of the package under control
throughout the process and using non-destructive methods offers a measurable
advantage.