Background:
Life
Science Outsourcing is an ISTA certified packaging test lab (ID Number ST-2339),
which is also FDA registered and ISO 9002/EN46002 certified.
Many companies
offer package testing services such as vibration and drop testing. Even UPS and
Federal Express offer limited services. The word "limited" is the key
word to remember.
Most of these facilities wouldn’t know the difference
between a single or double sterile barrier, let alone write a protocol to test
the efficacy of the package. These test facilities are set up to test every imaginable
type of product, from one pound bags of whole-bean coffee to five pound boxes
of roofing nails, and even your favorite canned beverage in convenient 24-packs.
Once the testing is complete, you may receive a computer printout of the
test results with some explanation as to how the test was conducted, test parameters,
or certification of test results. But, it is up to you to compile the data into
a useful format and final report. You will have to review the data, write the
conclusions and then possibly have to defend the test methodologies and conclusions
to your regulatory agency auditor.
At some point you may have to use more
than one facility to conduct all of your required testing. Writing a final report
based on test results obtained from several different facilities, or from testing
facilities that do not specialize in medical products, can be a very challenging
experience. Unless you are very familiar with the requirements, it is not a good
idea to guess what information an auditor expects to see in a final validation
report.
