Maintenance of Class 9/8 clean room in a medical devices factory

T

Teeker

#31
A slightly different question, but related to the topics in this thread: I have always worked for sterile, surgical medical device (non-implant) manufacturers. The companies I have worked with certify their cleanrooms to ISO class 8 and I know what it takes to do that.

I am now with a new startup and in charge of setting up the cleanroom. I was going to default to ISO class 8, but what really tells me what type of environment I need? I don't believe ISO 14644 tells me that since I manufacture a certain product that I need to be a certain class, does it?

So, what should I shoot for? Is a certified cleanroom required? Would FDA or ISO look down upon a non-certified "controlled environment" assuming my product appears clean and meets bio and pyrogen requirements? Any input would be appreciated.

- TK
 
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G

Gert Sorensen

#32
A slightly different question, but related to the topics in this thread: I have always worked for sterile, surgical medical device (non-implant) manufacturers. The companies I have worked with certify their cleanrooms to ISO class 8 and I know what it takes to do that.

I am now with a new startup and in charge of setting up the cleanroom. I was going to default to ISO class 8, but what really tells me what type of environment I need? I don't believe ISO 14644 tells me that since I manufacture a certain product that I need to be a certain class, does it?

So, what should I shoot for? Is a certified cleanroom required? Would FDA or ISO look down upon a non-certified "controlled environment" assuming my product appears clean and meets bio and pyrogen requirements? Any input would be appreciated.

- TK
You may wanna fill us in on the broad specs of the product, might be necessary to know a bit more before we hand out "advice" :bigwave:
 
T

Teeker

#33
We manufacture a class II (510k) disposable cardiovascular catheter devices. Manufacturing is mostly assembly of plastic and metal components and some laser welding. Parts are cleaned prior to entering manufacturing. The device trayed then pouched in a tyvek/mylar pouch. The device can be wiped down post-assembly, but not fully cleaned.

- TK
 
G

Gert Sorensen

#34
I am not a clean room expert, but I will try to give my input :)

I am now with a new startup and in charge of setting up the cleanroom. I was going to default to ISO class 8, but what really tells me what type of environment I need? I don't believe ISO 14644 tells me that since I manufacture a certain product that I need to be a certain class, does it?
As far as I read 14644 I agree that it does not specify any class for any product. What it does specify is operational limits for the class that you have chosen for your clean room, so my interpretation is that you, and only you, decide if you wan't to comply with 14644 and what class of clean room you wan't to/need to have for your production. If you choose not to go with 14644 you should state how you have determined your requirements for the clean room.

So, what should I shoot for? Is a certified cleanroom required? Would FDA or ISO look down upon a non-certified "controlled environment" assuming my product appears clean and meets bio and pyrogen requirements? Any input would be appreciated.
I have worked for companies producing class II products in a non-certified clean room under ISO certification, so I will wager a guess that as far as ISO is concerned there is no requirement to comply with 14644 as long as your products are clean, sterile and meet the requirements for pyrogenic residue. Any bidders on the FDA requirements?

We manufacture a class II (510k) disposable cardiovascular catheter devices. Manufacturing is mostly assembly of plastic and metal components and some laser welding. Parts are cleaned prior to entering manufacturing. The device trayed then pouched in a tyvek/mylar pouch. The device can be wiped down post-assembly, but not fully cleaned
The fact that it can't be cleaned after assembly certainly makes it more delicate to produce, but with proper handling it should not pose a problem. I am interested to hear how you control any pieces of metal chips or -splinters in a manner so as to make sure that the scrap does not accompany the finished catheter?
 
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