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Cleaning Validation Process of Non-Sterile Implants and Instruments

#1
Hi,

I am in charge of the cleaning and packaging validation of implants and instruments delivred non sterile.
I have some questions about the cleaning validation. Our orthopedic implants and instruments are machined, glass-beaded, passivated (if implantsà, etc...

1) for implants, they are cleaned by the subcontractor before packaging, sent to us, when we perform the QC and final packaging. Can we consider the cleaning performed by the subcontractor as the final cleaning? According to the definitions in ISO 19227, it should be a critical-in-process cleaning but i am not sure. We do not have any others cleanings after the "final one" performed by the subcontractor.

2) for the instruments, it is almost the same case: the instruments are machined, glass beaded, polished, melded, cleaned (here, it is the last cleaning performed), lazer marked, spot passivated (only on the marking spot) and not cleaned... Then it is packaged, sent to us for QC and finally packaged to be distributed. Same question, is it acceptable to validate the "final cleaning" performed before the lazer marking (no pollutants), the spot passivation, etc... Some people consider that the passivation is a cleaning step. I do not kwnow which cleaning step must be considered as a final cleaning and if it is acceptable.

Thanks for your help.
 
#2
Hi,

I am in charge of the cleaning and packaging validation of implants and instruments delivred non sterile.
I have some questions about the cleaning validation. Our orthopedic implants and instruments are machined, glass-beaded, passivated (if implantsà, etc...

1) for implants, they are cleaned by the subcontractor before packaging, sent to us, when we perform the QC and final packaging. Can we consider the cleaning performed by the subcontractor as the final cleaning? According to the definitions in ISO 19227, it should be a critical-in-process cleaning but i am not sure. We do not have any others cleanings after the "final one" performed by the subcontractor.

Thanks for your help.
:2cents:
You must atleast have a 'verification' process; and supported by (/verified) 'validation of the cleaning process used by the sub-contractor'
you should also consider (formal risk-assess) the exposure of device during unit-operations at your facility; it is also required to add the customer requirements and work backwards from there.

Hi,
2) for the instruments, it is almost the same case: the instruments are machined, glass beaded, polished, melded, cleaned (here, it is the last cleaning performed), lazer marked, spot passivated (only on the marking spot) and not cleaned... Then it is packaged, sent to us for QC and finally packaged to be distributed. Same question, is it acceptable to validate the "final cleaning" performed before the lazer marking (no pollutants), the spot passivation, etc... Some people consider that the passivation is a cleaning step. I do not kwnow which cleaning step must be considered as a final cleaning and if it is acceptable.
.
as I read it...passivation is more about the steps to protect the device; and cleaning is more about the protection to end-user(patient);
Even if the customer is doing sterilization at his end, it is minimum requirement to have the microbial controls inplace at your end ( bio burden limits) it is required to have the requirements listed out by the customer:2cents:
 
#3
enorht,

some additional comments

ad (1) Can we consider the cleaning performed by the subcontractor as the final cleaning?

The answer depends on what you have defined as cleanliness requirements for your device ready-to-ship and whether these requirements match the cleanliness acceptance criteria of your sub-supplier. If they match, then you are done. I suspect, however, that they will differ significantly, except your cleaning sub-contractor is used to provide this specific cleaning service to the (orthopedic implant) medical device industry.

ad (2) again - the answer is "it depends": in case your cleanliness acceptance are still met when additional manufacturing processes are performed on you device after a so-called cleaning step, then your approach might be acceptable. But you might want to document at least a solid rationale (if not include dedicated testing) why you current cleaning approach is adequate with regards to the intended use of your device.

HTH,

Gerhard
 

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