ASTM vs. ISTA for Package Testing – Which Is Better?
So many standards, so little time. Faced with uncertainty over transit testing standards? You certainly have options:
- ISTA 1A
- ISTA 2A
- ISTA 3A
- ASTM D4169
If you’re feeling a little lost, you’re not alone. The top consideration to guide your transit tests is the answer to this question:
How will your product get from manufacturing floor to end user?
ISTA AND ASTM standards put sterile products through simulations that address distinctly different distribution scenarios. The real-world, worst-case scenarios your sterile product could face will vary greatly based on how it will be shipped.
Ordering tests that focus on unlikely scenarios for your product’s journey are a waste of time and money. The wrong tests can also leave you at risk for actual situations that could occur.
The Differences: ISTA vs. ASTM
Both ASTM and ISTA standards have dual approaches to transit testing.
ASTM tests include:
- ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM D7386: Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems (such as UPS and FedEx, where comparably lower volumes of product are delivered, altering the transit experience)
- Universal requirements for ASTM D4169 and D7386 testing are clearly stated and must be followed. There are other testing criteria, such as levels, sequences, and orientations are up to you.
ISTA test methods include:
- Series 2: Partial Simulation Performance Tests
- Series 3: General Simulation Performance Tests
So what happened to “1A”? Here’s the deal: Although ISTA 1A method is listed as a transit standard, a review of the guidelines reveals that Series 1 is not meant as a validation method. The ISTA 1 Series is a feasibility study while in the design phase, so while it is related to transit, it applies to a much earlier part of the sterile device launch process.
ISTA Series 2 and Series 3 can be tailored to more specific situations or package configurations. ISTA 2A, ISTA 3A along with every other protocol in ISTA is very detailed and has specific step-by-step instructions that must be meticulously performed.
