Surprising shoe policies for Class 7 Cleanrooms

normhowe

Involved In Discussions
#1
We are manufacturing implantable devices for a clinical trial. The product will be terminally sterilized but will be manufactured in a class 7 cleanroom. Production policy is that booties are NOT required in the cleanroom. Workers can wear street shoes into the cleanroom. This seems surprising.

We are also told by medical personnel that operating room policy is typically that OR personnel wear street shoes in the OR where the device would be implanted. Again, this seems surprising.

Would really appreciated any comments or insights on these two surprising [to me] policies.
 
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Raisin picker

Quite Involved in Discussions
#2
Operating room policy varies between countries and clinics. The strictest rules so far I've observed at Semmelweis university (Budapest), but that comes with the name ;-)
I've always reveiced OR shoes (or, rarely, single use shoe covers). Cleaning of the OR shoes, however, ranged from never to daily ...

Typically, in the OR, clean air is coming from above the table, and drawn away at the bottom, so contamination from the shoes to the field of operation is unlikely (but still possible).

Can't talk about cleanrooms, have only been to one so far.

Well, things might be a bit different when you talk about IOLs or something similar (very short surgery under local anesthesia).
 

Zero_yield

"You can observe a lot by just watching."
#3
Hello! Fellow terminally sterilized implantables manufacturer. We do wear street shoes in our controlled environment with two single-use shoe covers. Some ancillary production areas use one single-use shoe cover or none, depending on risk.

To be fair, we tend to be fairly lose about controls for objects on the floors (like ergonomic mats at workstations), because any product that's dropped on the floor is rejected without question.

Not knowing all your controls, a couple things I would think about when assessing the need for shoe covers:

-Does your clean room struggle to stay in spec with particulate? Do you have problems with complaints for particular, or yield fallout for particulate during cosmetic inspections?
-How frequently are your floors cleaned?
-Is there a requirement to reject all product that touches the floor? Are there adequate controls / resources in place to allow this to happen (racks, tables, etc.)?
-What weather / environmental conditions do you have to deal with (i.e., are technicians tracking gobs of mud in during a rainy season)?
 

normhowe

Involved In Discussions
#4
Hello! Fellow terminally sterilized implantables manufacturer. We do wear street shoes in our controlled environment with two single-use shoe covers. Some ancillary production areas use one single-use shoe cover or none, depending on risk.

To be fair, we tend to be fairly lose about controls for objects on the floors (like ergonomic mats at workstations), because any product that's dropped on the floor is rejected without question.

Not knowing all your controls, a couple things I would think about when assessing the need for shoe covers:

-Does your clean room struggle to stay in spec with particulate? Do you have problems with complaints for particular, or yield fallout for particulate during cosmetic inspections?
-How frequently are your floors cleaned?
-Is there a requirement to reject all product that touches the floor? Are there adequate controls / resources in place to allow this to happen (racks, tables, etc.)?
-What weather / environmental conditions do you have to deal with (i.e., are technicians tracking gobs of mud in during a rainy season)?
Thanks for your insights. Just to be sure, You wear covers over your street shoes?
 

normhowe

Involved In Discussions
#5
Operating room policy varies between countries and clinics. The strictest rules so far I've observed at Semmelweis university (Budapest), but that comes with the name ;-)
I've always reveiced OR shoes (or, rarely, single use shoe covers). Cleaning of the OR shoes, however, ranged from never to daily ...

Typically, in the OR, clean air is coming from above the table, and drawn away at the bottom, so contamination from the shoes to the field of operation is unlikely (but still possible).

Can't talk about cleanrooms, have only been to one so far.

Well, things might be a bit different when you talk about IOLs or something similar (very short surgery under local anesthesia).
I was in Budapest recently. I knew it was a beautiful city, but I was pleasantly surprised.
 

Zero_yield

"You can observe a lot by just watching."
#6
Thanks for your insights. Just to be sure, You wear covers over your street shoes?
Yes, we wear covers over street shoes in the controlled environments. We are able to stay within the requirements of an ISO Class 7 environment with this setup.
 
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