Sterile Medical Device Storage Requirements

T

touch89

Good Morning to all!
I have a question to you, our Quality Consultant said to us that the Sterile Medical Devices should be storage in a separate shelf from the other. But I can't find it in the ISO 13485...

Could you confirm if that is right?

(sorry for my bad english!! I'm Italian :D)

Thank you for reply
 
P

pkost

Trusted Information Resource
there is no requirement to store sterile products on a seperate shelf once it's final product

There are requirements to segregate items for various reasons e.g. non conforming product - sterile, final product and "to be sterilised" product should be seperated.

There is no detail on how segregation should occur, no mention of "shelf" in the standard! If you need seperation you could put a seperator between the products on the same shelf...many different solutions, it just needs to be effective.

Ask the consultant to show you the requirements in the standard and why it is important - he may just be advising best practice
 
S

SteveK

I agree fully with pkost. Your consultant could be interpreting:

7.5.5

The organization shall establish documented procedures or documented work instructions for the control of product with a limited shelf-life or requiring special storage conditions. Such special storage conditions shall be control/ed and recorded (see 4.2.4).

to mean storing separately, just a thought!

Steve
 
T

touch89

Thank you guys for the moment, I'm thinking the same thing of you!
 
Ajit Basrur

Ajit Basrur

Leader
Admin
I totally agree with previous posts. There is no such requirement and the consultant may have recommended this to ensure that sterile product does not get mixed with non sterile but on a larger scale, the organization must demonstrate effective controls over individual lot/product too.
 
T

touch89

Our Company is a Dental Depot, we don't produce anything so I think we haven't problem stock the product without separate the Sterile ones.
 
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