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ETO Sterilised Class II Medical Device - Required Temperature Storage

#1
Hi all,

I've recently inherited an existing product to manage. It currently has a specified temperature storage range of 10-30 degrees. This is unfortunately causing some problems with storage and monitoring of temps.

Upon speaking to people, no one seems to know how we came to this temperature range. A lot of our products certainly require specialist storage due to chemical components but this has none. Also, whilst speaking with our sterilisation manufacturer they commented that very few products that they sterilise in pouches by ETO are labelled with a temperature storage range?

Is a storage temperature required to be on the label or has someone been over zealous in the past and restricted our storage options?

The product is simply stainless steel and polyester. I'm hopefully looking too increase temp range or if justifiable remove it completely. Alas having trouble finding concrete specs.

Thanks for your answers.
 
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#2
Chris,

Storage temperature may be driven not by (only) the packaged product, but (more often) by the sterile barrier system and its associated stability / shelf life validation according to ISO 11607-1. This may also be the case for your product. Specifically for your product, you should have a shelf-life validation report on file, that demonstrates that your product can be stored at 30 °C (which generally implies that any lower temperature, including your min of 10 °C is also fine) over the labelled shelf life.

Since you cannot store pouches at arbitrarily high temperatures you always to have to label at least an upper storage temperature. Typically, there is no justification to completely remove temperature labelling on sterile barrier systems.

Regarding the comment of your contract steriliser: this is worrisome, since these products in pouches are actually mislabelled. (Typically, a lot of low-risk products are sealed in pouches, that have little or no regulatory oversight.) Another option could be that final labelling for distribution only happens after sterilisation on return to the manufacturer. This way your contractor would not see the full picture.

You can extend your labelled temperature range if your shelf life validation covers the desired, extended temperature range.

HTH,
 
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