Introducing ASTM D 7386-08
A new package performance standard was introduced in 2008 by ASTM. Officially titled “Performance Testing of Packages for Single Parcel Delivery Systems”, the specification is designed for packages weighing less than 150 lbs to be challenged to the anticipated hazards normally encountered in the distribution environment. Although similar to ASTM D4169 in regards to Vibration, Altitude and Impact testing, D7386 incorporates new hazards such as Bridged Impact, Hazard Impact, Concentrated Impact, Vibration while under Compression and a Tip Over test. In D7386, the Vibration profiles have been modernized and the Impact test sequence modified.
To formulate your test sequence, selection of these test inputs – known as Schedules- will be determined by the shippers’ dimensions, volume and length ratios. In addition to standard packaging, ASTM D7386 can also be conducted on packages that are bagged for transport, cylindrical containers and large, flat shippers. This is a challenging test that will provide you with a good amount of information and confidence regarding your package system’s integrity in the distribution environment.
What Does the FDA Want to See?
If you are developing a medical device, this is a question you must ask at some point. Basically, the FDA wants you to develop a justifiable test plan, and test your package systems according to that plan. ISO 11607 is an excellent guideline for validating a package system. It gives suggestions for package challenge testing (distribution), package integrity testing, as well as shelf life testing. If your medical device states an expiration date on the label, you must prove that the package integrity remains intact following the shelf life testing. This can be completed in the laboratory by conducting quantitative (peel and burst) testing as well as qualitative (bubble and dye penetration) testing following accelerated and real time aging studies. Contact WESTPAK to help start you in the right direction for validation of a medical device package.
ISTA Certification: Questions and Answers
1. Can anyone receive ISTA Certification?
Answer: ISTA certification is a member-only benefit that our Shipper members are eligible for. A product manufacturer must be a Shipper member of ISTA and have a signed License Agreement on file before they can claim ISTA certification on their packaged-products.
2. Does the Preconditioning at 6 hours have to be done in order to receive the ISTA Certification?
Answer: Yes…and the last 6 hours should be recorded on the test report form.
3. Client wants to run several conditions over a 72 hour profile. Does the ISTA procedures allow for this under the “know your distribution environment clause”, and would this meet ISTA 2A certification requirements?
Answer: You can run that type of sequence - It would be considered “User Defined”.
4. Is it acceptable to run vibration longer than what is specified?
Answer: All of the ISTA testing procedures show a test level minimum, meaning that, as a minimum, those test levels or times must be met. Anything above the minimum is perfectly acceptable and would be what we consider "exceeding procedure minimums".
5. Client does not want the boxes opened throughout testing. Can there be a comment regarding external observations, have the package systems sent back to the client for inspections, and have them report back with their findings?Can all this be placed in the certification form?
Answer: This is acceptable. Under the "Method for determining pass/fail" on the test report I would recommend you add "customer inspection at end of test". Then have your customer give you written confirmation of the results, which should be attached to the test report.
6. Can we still certify a pack without inspecting internally? …as long as we comment on normal denting, scuffing, sustaining compression, etc? Is that what the pass/fail boxes are for after the initial and final vibration in the report form?
Answer: for the 2009 procedures and report forms, we will be removing the inspection comment. The line that allows it is contradictory in that you are not allowed to alter the "current condition of the package or the condition or position of the product(s)", however the simple act of opening the package during testing alters it, so we will remove that step in every procedure. Inspection can still be done on those packaged-products that are not being submitted to ISTA for certification.
-All questions answered by Meredith Dougherty of ISTA
