Many medical device manufacturers (MDMs) struggle with the development of a packaging system design qualification test plan for compliance to ISO 11607. ISO 11607 requires that sterile medical device package systems be capable of withstanding the transportation and distribution environment. This is typically accomplished by performing a package performance test protocol consisting of a series of laboratory tests that simulate the dynamic and environmental hazards associated with the distribution of products to their end use.
Distribution simulation testing is a uniform and repeatable way of evaluating packaging systems by utilizing laboratory equipment to subject the packaging system to specific hazards that may occur within the anticipated distribution environment. The primary goal is to have an effective shipping configuration that protects the product and package integrity during transit, and ultimately is in compliance with ISO 11607.
One challenge many MDMs have is to determine which procedure to specify for performance testing. There are several distribution simulation test methods that can be used for package performance testing.
The ISO 11607 standard recommends the use of the ASTM and ISTA standards for simulating these hazards in the laboratory. The ASTM D4169 standard has been used extensively in the medical device industry for FDA compliance and has a solid history of releasing high-performing package designs into commerce, as well as identifying potential failures and hazards. ISTA test methods are also acceptable alternatives to the ASTM methods used by many MDMs for compliance to ISO 11607.
There are a couple of issues to consider when determining which standard to use for compliance purposes. The first is whether the test method is recognized as a consensus standard by FDA. The second is whether the test intensity of the procedures simulating the environment in which the packages will be transported is realistic.
Below are a few tips to consider before making any decisions on your distribution simulation testing.
- Work with your testing lab to understand the specific test procedure that you will use to evaluate your shipping configuration for validation.
- Perform feasibility testing prior to executing a full blown performance test (shipping/environmental study).
- Work with your package testing lab to ensure you’re using a test procedure that is going to best simulate your distribution environment.
- Understand the percent of defects that you are acquiring in shipping your sterile samples to the customer / end user.
- Provide adequate time to perform a thorough validation.