Why Use Medical Package Testing?

Background:

Medical Package Testing 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.

We fully understand the regulatory requirements and compliance issues involved with sterile, non-sterile, reusable, biological and pharmaceutical products. Our knowledge is based on over 20 years of hands-on experience in the manufacturing, packaging and testing of medical products.

Our Promise:

At Medical Package Testing, we promise to:

• Create a protocol specifically tailored to your package/product requirements. This document is very detailed and suitably organized.

• Provide complete evidence of testing and test results. This includes digital photographs, charts from data recorders and computer printouts.

• Compile the data along with the digital photos, charts, etc. into a complete final report. We will then review the test results and compare them with the protocol requirements. We will provide an executive summary and certification of compliance with the final report.

• Create a completely self-contained final report, which is organized to satisfy the most demanding auditor from any regulatory agency.

• Keep a copy of your final report on file so that you will always have access to the report, even if you happen to misplace your copy.

Life Science Outsourcing, Inc.
830 Challenger Street
Brea, CA  92821

Phone: (714) 672-1090
FAX: (714) 672-1093
Email: info@lso-inc.com
Website: www.lso-inc.com