Orthopedic implant sterility testing

#1
Can the samples (orthopedic implant) used in sterility testing be reprocessed(cleaned, packaged) and resterilized ? What kind of assessment/validation is required ?
Thank you
 
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planB

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#2
Principally yes - however, you would at least have to

- validate your cleaning process taking into account the (probably uncontrolled) sample handling after the test of sterility
- validate the impact of re-sterilization on your product
- assess whether these re-used samples still really meet the specification of virgin, un-used product

These activities will probably require more samples than you can safe with this tedious effort, plus you probably deviate from the routine manufacturing process in a severe way, introducing new risks that need to be controlled.

Hope this helps,
 
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