Medical Package Testing

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:

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