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Medical Device \ Pharmaceutical Packaging Testing

Validating packaging for medical devices and pharmaceuticals ensures the safe and effective use of your products when they reach the consumer.  Packaging for these safety-critical products must withstand the rigors of the manufacturing process, storage, and the distribution cycle.  Drugs sold in the United States must meet FDA packaging requirements as outlined in 21CFR211.94, and medical device packaging must meet the requirements of the FDA-recognized international standard ISO 11607. Our package testing experts can help you decide what specific tests are necessary to prove compliance with ISO 11607. 

There are generally three categories of testing to prove compliance with ISO 11607:


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Package Integrity and Seal Strength Testing

Package integrity is crucial to maintaining sterility for medical devices, especially those that are to be used during medical procedures or implanted into patients. There are several types of tests that have been developed specifically to determine a package’s seal strength including bubble emissions testing, dye penetration testing, burst testing, and tensile testing. Here are a few of the specific standards that are used to validate package integrity and seal strength:

  • ASTM F1929 - Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
  • ASTM F2096 - Detecting Leaks in Packaging Through Bubble Testing
  • ASTM D3039 - Tensile Testing of Composite Materials
  • ASTM F88 - Seal Strength Testing of Flexible Barrier Materials
Medical Package Integrity Testing Services

Accelerated Aging or Shelf Life Testing

Shelf life testing must be performed to ensure that your products will survive in storage for periods of time and maintain their safety and efficacy. Claims about the shelf life or your product must be validated by data obtained during testing. Accelerated aging testing is used to produce initial conservative estimates of a product’s shelf life. Accelerated aging is a type of testing that utilizes extreme temperature, humidity, vibration, and other types of environmental factors to artificially speed up the normal aging process. The known reactivity relationships between the environmental conditions and the materials being testing combined with the test conditions are used to estimate the shelf life. The shelf life that is determined during accelerated aging should be validated with real-time testing. The standard used to complete shelf life testing is:

  • ASTM F1980 - Accelerated Aging of Sterile Barrier Systems for Medical Devices
Medical Package Performance Testing Services

Distribution Simulation Testing

Like any product headed to its final destination, medical device packaging must hold up to being dropped, stacked and shaken several times during the process of distribution. Aside from the safety implications of maintaining sterility within the device packaging, manufacturers can limit the amount of product that is lost or damaged through thorough distribution simulation testing.

  • ASTM D4169 - Standard Performance Testing of Shipping Containers and Systems
  • ASTM D7386 - Standard Performance Testing of Packages for Single-parcel Delivery
  • ASTM D642 - Compression Testing of Shipping Containers
  • ISTA Series 2 & Series 3 - Package Distribution Testing
Medical Package Distribution Testing Services
ISTA Certified Package Testing 

Tektronix testing services labs are ISTA certified to perform a variety of tests. 

Boston (Billerica), Massachusetts
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ISO 17025 Accredited Testing Services 

Tektronix is certified by A2LA  as an ISO/IEC 17025 Accredited laboratory. View Certificate...