EO Sterilization Indicators on Pouch and/or Carton

B

BCanada

#1
Hi there,

We currently have medical devices sealed in a tyvek pouch and placed in a carton (EO sterilized, one time use). The pouch and carton are both sterilized. The EO indicator is placed on the pouch.

Is there a requirement as to where the EO indicator must be placed?

Thanks,

Brenda:thanx:
 
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M

MIREGMGR

#2
Re: EO Indicators on Pouch and/or Carton

Generally the first-tier medical device regulatory systems, including the EU in accord with ISO 11135-1, provide that EO exposure indicators may be used for logistical or marketing reasons, but not as an indicator that sterilization has been accomplished. So, since such indicators have no regulatory function, you can put them wherever you want. Just don't label them as sterilization indicators.
 
B

BCanada

#3
Re: EO Indicators on Pouch and/or Carton

Does anyone else have any feedback on this topic?
 
J

Jshene

#4
Re: EO Indicators on Pouch and/or Carton

As a contract Manufacturer for medical devices that get sent out for sterilization and then shipped back to be repackaged we put the indicators inside the shipping boxes and not on the product its self.
 
M

MIREGMGR

#5
Re: EO Indicators on Pouch and/or Carton

The relevant statement regarding chemical indicators within ANSI.AAMI/ISO 11135-1:2007 is Section 8.8, second sentence.

EO sterilization per that standard of course is never performed on a verified-by-indicator basis. It always is performed in a validated-consistent manner to a process specification that is established by standardized means. Thus no indicators are used to verify sterilization of production loads because all of the work to establish the standardized cycle parameters to consistently achieve a 10-to-the-minus-sixth reduction under worst case conditions has already been done during process validation.

The indicators that are used during establishment of the validity of the sterilization process, i.e. biological indicators, are required in Section 8.6 to be placed "within the product at location(s) where sterilizing conditions are most difficult to achieve or be placed within a PCD", and the PCD at its specified location must be separately validated to be more difficult to sterilize than the most-difficult-to-sterilize part of the product. Thus putting such an indicator on the outside of a pouch, or anywhere else on the outside of packaging, probably would be unacceptable because it would not be the most-difficult-to-sterilize part of the product.

But, any indicator can be used for anything else, including providing evidence to customers that the claimed exposure to EO actually occurred, as long as that indicator isn't the basis for a product-is-sterile claim.
 
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