Shipping Validation of Non-Sterile Parts?


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Hello all, this is a bit of a long post but I think a lot of people could benefit from clarifying these subjects. I was reviewing requirements for shipping validation of non-sterile parts for medical devices (in the DHF) and process validation (in the DMR). There are some situations that just aren't mentioned by any regulations/guidances (neither by US FDA nor internationally):
  • If you ship parts during the manufacturing process, then do you need to 'validate' the shipping method first? For example: you could have subcontract manufacturer A who manufactures a subassembly (containing sensitive electronics), and it then gets shipped to subcontract manufacturer B who performs work to convert it to a full assembly. In this situation, I believe that you do not need to perform a shipping validation for transport. Sure, you can do a choose an adequate packaging, but the 'evidence' that the shipping was good was if your end verification/validation of the finished assembly is good.
  • If a subcontract manufacturer sends you a spare part assembly to store in your own warehouse, does that require shipping validation for the spare part? I am on the fence. I believe that if you conduct a verification check after the shipping, or if you do your testing for "manufacturing process validation" after the part gets shipped to your own warehouse, then the shipping process itself doesn't need to be validated. Whatever happened during the shipment is 'factored into' the later validation testing.
  • When you have a stockpile of spare parts in your warehouse, and you need to send a spare part to a customer, do you need to perform shipping validation of that spare part? I just can't find any regulations/guidance that make the distinction between requiring shipping validation of a finished medical device versus its spare parts.
  • Do any of the above situations matter whether it's just a piece of steel (like a screw or non-sterile probe) versus a delicate assembly with electronics inside? It's my understanding that you can make a risk-based determination that simple steel parts never need shipping validation, whereas delicate assemblies would always require shipping validation. But there's just no guidance out there on the subject.
I didn't read anything related when I read either the FDA Guidance "Process Validation: General Principles and Practices" dated Jan 2011 or the FDA Webinar "Quality Systems Regulation Process Validation" dated Sep 30, 2015. I'd be glad to read through any standards or regulations/guidances that may apply here. Thank you.
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Was hoping someone else would jump in but since no takers yet, here goes.

You're responsible for ensuring (and I'm quoting from 13485 here) product is protected "from alteration, contamination, or damage
when exposed to expected conditions and hazards during processing, storage, handling, and distribution..." Clearly, that's the driver for product packaging validation. It's completely out of your custody at that point so it needs to be adequately protected.

As you point out, there are no requirements established for other packaging / transportation aspects. For internal transports, the materials remain in your custody and you are the experts in knowing if something is damaged and presumably have controls to prevent nonconforming product (resulting from damages to materials during internal shipments) from being distributed. So I can see a rationale for not doing shipping validation there.

As you note, you can take a risk-based approach to shipping components to a customer. The conservative approach, of course, would be to validate, but I think not validating packaging for a rather indestructible component would be defensible.


Involved In Discussions
I see, thank you. I guess there really is no guidance/regulation out there regarding shipping spare parts to customers. This is a bit disappointing because it's such a common activity in the industry that I thought there would at least be some white papers on the subject.

I supposed I really should perform shipping validation of the electrical component, when it is being shipped to a customer as a spare part by itself. Do you think I could get away with literally just mailing it across the country and then mailing it back to me, then doing a visual/functional test? Or would I need to perform a full validation per the standards ASTM D4332 and ASTM D4169? It's just a spare part but it's my most sensitive one.


Super Moderator
I've successfully used FedEx testing for shipping validations. They have their own take on the ASTM standards but I think the testing is the same. It's free except for the shipping costs.


Involved In Discussions
Have you done an in-house shipping validation, where you just shipped a box across the country and back using FedEx?

Was it for a Class 2 device? Did FDA ever look at your shipping validation methods and were OK with it?

I ask because ASTM D4169 is an FDA-recognized consensus standard, making me think that it's the only way to go for Class 2 and Class 3 devices. I can understand if an in-house FedEx shipping validation is OK for a Class 1 device, but I didn't think it's also acceptable for higher-risk devices.


Super Moderator
No, because that's not a controlled test - you can't be sure of the stresses it underwent. You can see the test types they offer here and you can drill down to see how it compares with the ASTM standard. If I recall, the test conditions are suitably similar. I've done this for Class II devices and no push-back yet.

(NOTE: I think it's free if you have an account with them.)


Involved In Discussions
Oh! I understand now, thank you! I had thought you meant literally just ship a package via FedEx via plane/truck and back. But in reality, FedEx actually offers formal testing services that comply with the FDA-recognized consensus standards. They are a formal testing laboratory. This is great news!


Involved In Discussions
Hi, I just wanted to give a quick update. I confirmed with FedEx that the free FedEx testing is not complaint to either FDA-recognized standard ISTA 3A or ASTM D4169-16. The "FedEx 6A" testing protocol is based on ISTA 3A but FedEx adds their own testing differences based on how FedEx sees their own packages shipped typically (stacked on top of each other, etc.) The purpose of the FedEx 6A testing is to 'approve' your package when shipped via FedEx, for claim purposes in case it gets damaged during transit with them. So just fair warning, I'm not sure if you did something different than what I had described.


Quite Involved in Discussions
I had a great time reading through the thread, will be applicable for EU MDR as well.

Article 23

"shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States."
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