Do I need a Cleanroom to manufacture Medical Devices?

J1980b

Starting to get Involved
#1
Good day to you all,

I have a simple question but I can't seem to find a definiate answer anywhere.

To manufacture medical devices, do I need a cleanroom?

In other words will a simple controlled area be sufficent, for certain products? For sterilisation purposes I can still account for Bioburden levels.

Thanks you
 
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G

Gert Sorensen

#2
Re: Do I need a cleanroom?

If you need to supply your products sterile then you need to have a cleanroom.

If you can already account for bioburden then you must have something that resembles a cleanromm already, right?
 

somashekar

Staff member
Super Moderator
#3
Good day to you all,

I have a simple question but I can't seem to find a definiate answer anywhere.

To manufacture medical devices, do I need a cleanroom?

In other words will a simple controlled area be sufficent, for certain products? For sterilisation purposes I can still account for Bioburden levels.

Thanks you
Your simple question has no simple answer.
For that reason you have what we call risk management, which when done scientifically, will answer your own question.
To manufacture medical devices, do I need a cleanroom?
What is the outcome of your risk management ?
Your control of risk not only will answer YES or NO to this but will further also answer what class of clean room you will need.
So answer will be DETERMINE YOURSELF ~~~
 
M

MIREGMGR

#4
"Cleanroom" doesn't have a universally agreed meaning. If you already are achieving consistently controlled and sufficiently low bioburden levels (i.e. not exceeding some upper threshold, every time), you already have an environmentally controlled area.

The "controls" for instance might be secondary to other purposes, i.e. your whole factory is maintained at that level of cleanliness for other reasons. That's fine...there's no requirement that controlled bioburden be achieved via capabilities put in place specifically for that purpose. All that matters is the result, and perfect consistency.

If your present bioburden level and character is consistent with the capability of your sterilization process and the other requirements of your product (i.e. implantables and fluid contact devices have pyrogenicity requirements, etc.), you're already where you need to be. If not, you may have to step up your game to achieve more cleanliness. If the only way to assuredly get and perfectly consistently maintain the level of cleanliness you need is to create a purpose built space, so be it.

Bottom line: it's results that matter. There is no requirement to have a cleanroom unless you need one to achieve the required results, which are a requirement.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
@ J1980b - Please note that some sorts of medical devices / applications may be adversely affected by the presence of non-viable particulate matter; hence, a controlled "cleanroom" environment (e.g. ISO 14644 class 8 etc.) may be important for other-than-bioburden-control purposes.
 
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