Karli "KC" C. If you start by defining the maximum acceptable number of particles for your process, can you define the cleanroom from that?

There are a number of factors to consider. Without knowing the details of your product, some questions I would ask are is a cleanroom absolutely required? There are also likely controls to address regarding sterilization validation and ongoing monitoring.

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All the best, Pierre

Hi Sandro,
The Art of your planed product and how you Plan to deliver it, e.g. sterile, defines your requirement.
With more information about your product I can provide you more detailed requierments

Sandro Ferrari @Karli, this is actually how we did. We have been trying to identify what part of the process must be particle free because of impact on functional device performances and the part requiring aseptic condition.
@Jon In the end, the answer is yes, it is absolutely necessary, I was just courious to learn if there is any other additional source of info. I found very useful the PIC/S PE009 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS.

Michael Chellson, RAC John has it right it all starts with the design requirement. For an invasive device determine the particulate both viable and non viable that will not cause a biological reaction and set your design requirement at that. for a non-invasive device allowable viable and non-viable particulate requirement would be much higher. from that requirement it is simple to determine what level of environmental control is necessary for the manufacture of the device.

Michael Chellson, RAC it all depends upon the use of your device if its a long term implantable it's necessary to determine the particulate load that will not cause a biological reaction and then set that requirement within your design history file. if it is a noninvasive device then that particulate load requirement will be much higher.

This type of Cleanroom will depend on what type of product you are marking. If you manufacture a product that is used for inside the body the spects need to be much tighter and will watched. If you are marking a support product that is used by doctors inside a. operating room there are different procedures to follow. I believe. the Cleanroom can be devided into different levels. A example you could have medical devices that are used in the body done during level one spent. This would take in head covers and scrubs along with boot covers. The level two maybe just during uniforms and head covers. Some rooms use airfilters like hospitals do. Thanks R.B.