Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment?

[Judy Abbott]

I received a change request for a product transfer from site A to site B. As part of the transfer, the product design, manufacturing process, inspection and test methods, materials tooling, suppliers, and manufacturing and testing equipment remain the same as the current commercial manufacturing of the device. Moreover, the device will be manufactured within the existing cleanroom in site B which used to manufacture other commercial products. Based on this information, I approved the change and mentioned it DOES NOT IMPACT BIOCOMPATIBILITY.

Now, BSI came back requesting some additional information regarding biological safety. Specifically, they want a more technical rationale as to why no additional biocompatibility testing was needed.

May you please support me with your suggestions and ideas?

 

[Ronen E]

Prepare a detailed risk assessment and evaluation concerning any possible effects on the makeup or contamination of the finished device at site B, including addressing "other commercial products" made there (past and present), and submit to BSI.

 

[Judy Abbott]

Prepare a detailed risk assessment and evaluation concerning any possible effects on the makeup or contamination of the finished device at site B, including addressing "other commercial products" made there (past and present), and submit to BSI.

Thank you, Ronen! I am preparing a list of the possible impact on the finished device. Considering the fact that manufacturing, design, tooling, materials, suppliers,... are the same and the only difference is the location, may you please share your thoughts if you can think of any impact? Thanks a lot for taking the time to help me.

 

[planB]

Judy,

refer to ISO 10993-1:2018, section B.4.5.1 "Changes which can require re-evaluation of biological safety" for guidance what to consider for the risk assessment Ronen mentioned above.

HTH

 

[Judy Abbott]

Judy,

refer to ISO 10993-1:2018, section B.4.5.1 "Changes which can require re-evaluation of biological safety" for guidance what to consider for the risk assessment Ronen mentioned above.

HTH

Thank you for pointing me in the right direction! Your suggestions always help!

 

[Watchcat]

it DOES NOT IMPACT BIOCOMPATIBILITY

I think the question BSI is asking is, "And you know this, how?" I think it's a reasonable question. I concur with Ronen E's reference to B.4.5.1.

I have to say, "the device will be manufactured within the existing cleanroom in site B which used to manufacture other commercial products" made me uncomfortable, and now more so, because Ronen E seems to have interpreted it differently than I did, and I think his point is valid, too.

I took it to mean that, if the cleanroom at Site B is good enough for "other commercial products," it is good enough for this one, too. I don't think that assumption is valid. I think Ronen E took it as a concern for cross-contamination, which I think is a valid concern.

 

[Judy Abbott]

I think the question BSI is asking is, "And you know this, how?" I think it's a reasonable question. I concur with Ronen E's reference to B.4.5.1.

I have to say, "the device will be manufactured within the existing cleanroom in site B which used to manufacture other commercial products" made me uncomfortable, and now more so, because Ronen E seems to have interpreted it differently than I did, and I think his point is valid, too.

I took it to mean that, if the cleanroom at Site B is good enough for "other commercial products," it is good enough for this one, too. I don't think that assumption is valid. I think Ronen E took it as a concern for cross-contamination, which I think is a valid concern.

Yes, Unfortunately, I did not see that possibility during my impact assessment. Do you think a cytotoxicity test can resolve this concern?

 

[Watchcat]

Hmm. I'd have to give that some thought. In the meantime, maybe Ronen E can give you an answer off the top of his head.

I will say that my gut reaction is not to do another test, but to consult your process risk analysis, which should (heh) include risks related to contamination. It's possible you could address BSI's question with existing cleanroom data.

 

[Judy Abbott]

Hmm. I'd have to give that some thought. In the meantime, maybe Ronen E can give you an answer off the top of his head.

I will say that my gut reaction is not to do another test, but to consult your process risk analysis, which should (heh) include risks related to contamination. It's possible you could address BSI's question with existing cleanroom data.

Thank you!

 

[Ronen E]

Do you think a cytotoxicity test can resolve this concern?

That's a risk mitigation activity. I wouldn't take any action mitigating any hypothetical risks without first being convinced that an unacceptable risk is present, and that the mitigation is likely to be effective (reduce the risk to an acceptable level).