Our Medical Package Testing division (MPT) was created to provide all medical product companies with the expertise and services necessary to design, qualify and/or validate a packaged product to meet both domestic and international regulatory requirements. MPT can provide you with a complete and comprehensive packaging solution and tailor services to suit your specific needs.

Why Perform Medical Package Testing?

Medical package testing takes place in a test facility that simulates the rigors of air and land shipping and determines if a manufacturer’s packaging is designed to withstand the effects of extremes in temperature and humidity. Using environmental chambers, real world conditions are replicated and precise cause and effect measurements are taken. The key question being addressed is, does the product arrive intact and sterile? A skilled packaging testing laboratory will be able to perform these tests and then make recommendations for changes in design, if necessary, based on test outcomes.

Performance Testing

Environmental conditions such as temperature and humidity levels are not the only factors that affect materials during shipping. Handling of the package and constant exposure to low and high levels of vibration may impact an otherwise soundly designed package. A variety of different testing devices, including vibration, drop, and compression, are used under controlled conditions to simulate road, rail, and air transportation.

A reputable medical packaging testing company should be equipped to test virtually any kind of packaging that is commonly used in the medical device industry.

There really is no way of knowing whether or not medical packaging will be able to withstand the normal stresses of transportation without putting it through a rigorous testing process. Determining any problems with packaging before mass production will save a manufacturer both time and money, and will assure that the finished product is in compliance with ASTM standards.

At MPT, 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 a decade of hands-on experience in the manufacturing, packaging and testing of medical products. We are an ISTA certified packaging test lab (ID Number ST-2339), which is also FDA registered and ISO 13485:2003 certified.

At MPT, we promise to:

  • Evaluate your product/package
  • Create a detailed protocol specifically tailored to your package/product requirements
  • Provide the rationale for types of testing to be performed, sample quantity, order of tests and the applicable regulatory standards.
  • 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.
  • MPT will also perform tests designed to determine if your package design is adequate prior to starting the actual validation process.

Some of our clients are:

  • Acculase, Inc.
  • AngioTrax, Inc.
  • Bioserv Corporation
  • C. R. Bard, Inc.
  • EndiCOR Medical, Inc.
  • GALT Labs, Inc.
  • Implant Technologies Limited
  • Innovative Surgical Technologies, Inc.
  • Medical Product Specialists
  • Medstone International, Inc.
  • Medtronic
  • Miravant Medical Technologies
  • Ramus Medical Technologies
  • SunMedica, Inc.
  • T. Koros Surgical Instruments
  • TheraCardia, Inc.
  • Triflo Medical, Inc.
  • VidaMed, Inc.