Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements


Involved In Discussions
I've got a sterile device whose shelf life of four-years is based on completed real-time package integrity studies. Right now we do not have temperature and humidity labeling on our product. In fact in our IFU we say "no special storage conditions are necessary". Usually, when customers ask, they are okay with this... That all changed when today we had a customer that wanted the labeling to include storage and humidity requirements. Before we embark on testing to establish a temperature and humidity range, I need to know: Is there a requirement for storage conditions to be on a sterile medical device package label?

Ronen E

Problem Solver
Storage conditions limits need to be indicated where the device or the sterile packaging integrity might be compromised and exceeding those limits is a probable scenario.

I'm not quoting a single specific requirement that spells it out, however this can be derived from the Essential Requirements in the MDD.

This is a bit vague, but ER 13.3(i) states that the label must bear "any special storage and/or handling conditions".


Involved In Discussions
Thanks Ronen. That reg, unfortunately, is a bit vague.

I can't see why humidity and temperature extremes would affect package integrity, which is likely why they were not put on in the first place. But, until testing is completed, we can't be 100% sure... I'm afraid this could be a slippery slope which is why I'm hesitant to go down that route. i.e. different temp/humidity combinations, high/low altitude??

Ronen E

Problem Solver
You could consult about the technical aspect with the manufacturer of the unsealed pouches / blisters etc.


Super Moderator

some items to consider:

  1. At which temperature / temperature ranges did you perform your real-time package integrity study? Did you do an accelerated study as well? What was your temperature set-point there? Both "real-time" and "accelerated" temperature will provide you with an indication maximum storage temperature to label.
  2. In shelf life / stability studies, humidity is usually a parameter you monitor, but you do _not_ set - refer e.g. to ASTM 1980- 07, which says in section 6.5:

6.5 A humidity factor to calculate the accelerated aging time (AAT) is not applicable for accelerated aging protocols. Unrealistic or extreme temperature and humidity conditions may be of interest in overall sterile barrier system performance. However,this must be evaluated in a separate study and is not related to aging of the materials. See Appendix X3 for more
details on the use of humidity in accelerated aging protocols.

So in case your package integrity is really not affected by humidity, you can tell your customer that there actually are _no_ humidity requirements, which means that everything below 100 %rH would be OK.

For temperature, "no special requirements" usually means room temperature, which typically means a max. temp of 25°C If this is also the case for your device, you could either label room temperature or a max Temp of 25°C - if this correlates with your packaging integrity study set points.



I would base the requirement on labeling temperature and humidity range on a sterile device on
[FONT=&quot]Annex 1 section 8.3:[/FONT]
[FONT=&quot]Devices delivered in a sterile state must be designed, manufactured and[/FONT]
[FONT=&quot]packed in a non-reusable pack and/or according to appropriate[/FONT]
[FONT=&quot]procedures to ensure that they are sterile when placed on the market[/FONT]
[FONT=&quot]and remain sterile, under the storage and transport conditions laid[/FONT]
[FONT=&quot]down, until the protective packaging is damaged or opened.

[/FONT]If you do not define any e.g. temperature conditions, you are implicating, that it will remain sterile under any condition which means the sterile barrier will remain intact under any conditions. I am thinking of 2 situations: a) sales people leaving products in a car in summer, which may easily reach 75°C, b) uncontrolled unisolated warehouses which heat up in summer . So i believe, a temperature range on the product has to be given. [Otherwise I expect proof, that the packing withstands conditions - which ? high temperatures ? .]

Do the manufacturers of blister packing provide guiding values for that, or what are common values used ?
I do not see that there is a room temperature symbol for packaging.

I hope this helps the discussion[FONT=&quot]
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