Steam Sanitization Requirements for Parts for Medical Device Manufacturing

S

shamen

#1
Hello All:

Are there any ISO or comparable requirements/standards for steam sanitization of parts used in the manufacture of medical devices?

If it means anything, the parts are not components of the device but they do come into direct contact with components that comprise what the site ships out the door to distribution.

Any input is greatly appreciated!
 
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M

MIREGMGR

#3
Are you using this for cleaning/degreasing, for disinfection, or (possibly) for sterilization? Is the application in a pressure vessel, i.e. an autoclave, or is it an external process?

AAMI's ST79 applies to steam sterilization.

I don't know of anything that specifically addresses steam disinfection of devices. You however could adapt standards from the food industry, where steam cleaning/disinfection is common.
 
A

albridgeuk

#4
Hi

Why are you sterilizing?

If it is done to comply with FDA requirements, then it must be done to recognised standard and you will be expected to validate that your sterilizing is compliant with that standard.

You will also have to validate that your sterilising steam is fit for purpose (none condensable gases/superheat/dryness fraction).

Regards
Alex
 
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