Environmental Monitoring Requalifications for Medical Device Industry

J

jbburton

#1
Hi,
We are a med device company and currently carry out a regular environmental monitoring schedule on air microbial & particulate, compressed air micorbial & particulate, Microbial surface contact plates, water analysis.

However it has recently been suggested that these systems should undergo annual requalification. Can anyone direct me to the current ISO requirements for this requalification.
Any guidance is appreciated.

Thanks.

jbburton:bigwave:
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
Hi,
We are a med device company and currently carry out a regular environmental monitoring schedule on air microbial & particulate, compressed air micorbial & particulate, Microbial surface contact plates, water analysis.

However it has recently been suggested that these systems should undergo annual requalification. Can anyone direct me to the current ISO requirements for this requalification.
Any guidance is appreciated.

Thanks.

jbburton:bigwave:
Hi,

Does this help?

http://www.slideshare.net/netomoney/IVTEMOverview20090104

Cheers,
Ronen.
 
J

jbburton

#3
Thanks Ronen,
It helps but I am still not 100% sure as to the my requirements.

I now have another question it should possibly be a new post but I will ask anyway. The tap water that is used in the the personnell transits to wash hands should this be qualified if so what are the standards applicable?

Thanks for all help.
 
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