Cleaning Process after laser marking on orthopaedic implants

mpfizer

Involved In Discussions
#1
Hi,
we manufacture orthopaedic implants viz plates, screws, nails, joints etc. What is the type of cleaning process applicable to these products after laser marking , that is,

should it be ultrasonic cleaning or spot cleaning by hand where the laser marking is done. We do pre sterility bioburden testing and have a sterilization validation by

gamma radiation in place.

Is there any ISO or ASTM standard that defines the process to be followed for cleaning after laser marking on implants.

Any suggestions , views welcome.

Thanks

michelle
 
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somashekar

Staff member
Admin
#2
I would recommend the ultrasonic cleaning rather than spot because it covers the entire implant.
It is good that you have a gate point in pre-sterility bio-burden testing.
The ultrasonic cleaning and its further handling gets a confirmation in your bio-burden testing results.
Keep such a cleaning process in control so as to feed a stable challenge to the gamma sterilization process.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Bio Burden only addresses biological contamination. Cleaning needs to also address potential chemical residues / by products.
 

QM_123

Involved In Discussions
#4
Hi,
we manufacture orthopaedic implants viz plates, screws, nails, joints etc. What is the type of cleaning process applicable to these products after laser marking , that is,

should it be ultrasonic cleaning or spot cleaning by hand where the laser marking is done. We do pre sterility bioburden testing and have a sterilization validation by

gamma radiation in place.

Is there any ISO or ASTM standard that defines the process to be followed for cleaning after laser marking on implants.

Any suggestions , views welcome.

Thanks

michelle
Hello,

You may look at: " ISO 19227:2018 - Cleanliness of orthopedic implants - General requirements". As I remember there is not any information on cleaning after laser marking directly, but standard says something for cleanliness acceptance criteria.
 
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