ASTM D4169, ISTA 2A, ISTA 3A:
Often times we receive calls from clients that have a medical device ready to go, but haven’t assessed their transit testing needs yet. With all the excitement building around their device, companies can often get frustrated when they realize they cannot simply throw their product in a box and ship it. Transit testing is an important aspect of making sure your product gets from the manufacturer to the end user sterile and undamaged.
When selecting transit testing methods there are two avenues to go down- ASTM or ISTA. These are both recognized standards that can be utilized to test your packages sustainability in the transit environment. Now for the big question: Which one is right for your medical device?
To make the correct choice between methods, it’s important to first understand your product’s distribution method(s). Both standards contain several methods for testing packaging, and it’s important that you don’t waste valuable time and money conducting unnecessary tests on your package system. Consulting with a professional test lab is a surefire way to ensure that the appropriate testing is conducted for your product and its associated packaging system.
Both ASTM and ISTA methods contain two standard systems. ASTM has D4169: Standard Practice for Performance Testing of Shipping Containers and Systems, and D7386: Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems. ISTA addresses their procedures in Series 2: Partial Simulation Performance Tests, and Series 3: General Simulation Performance Tests.
Most of the procedures and methodologies for ASTM are outlined in the official documents, but levels, sequences, and orientations are up to the operator. ISTA is designed to be tailored to more specific situations or package configurations. The different series offer variety in cost and complexity. Each protocol in ISTA is very detailed and has specific step-by-step instructions that are harshly followed.
The easiest way to ensure that you are selecting the best testing method for your product is to work with a testing lab. Validation and Design Engineering Labs help evaluate the specific test methods that will work best for your shipping system. Packaging Compliance Labs also offers feasibility testing that can save on time and money!
Feasibility testing offers a company a chance to fully test shipping methods before undergoing the complete validation performance tests. This way you can work out the kinks before investing in larger testing and sample sizes. Finally, it is most important to simply plan for the validation process. The more prepared you can be going into it, the faster we can help speed you to market with confidence!