Manufacture Medical Devices

Do you sterlize them before shipping or gaurantee them to be sterile?

I would talk to quality control and possilbe the company lawyer.

Are employee free of communicable diseases?

That would be a big question outside of a clean room for me.

This is actually a very vague post. The medical 'device' needs to be clarified. If it is implantable it must adhere to more strict set of standards than say a delivery device such as a tray that would be used to transport and sterilize or protect instruments from damage. Another consideration is if you are the guarantee of sterility or there is a 'middle man' who does the evaluation and testing prior to market.

curious... HC

To what spec? STd? or regulation?

Typically, I have seen these processes outside cleanrooms, in same area as parts washing and machining.

Now lets think about this...

Are the cleaning, electro chemical, and passivation chemical solutions something that we would want to be fugitive in our device or patient after packaging and assembly?

If yes, then having these processes outgass splatter and otherwise available to spill and contaminate the products in the clean room would be fine.

What s the point of the clean room? Its to prevent the contamination of the product by contaminants of a chemical, mechanical, or biological nature.

In some critical applications, I could see a hierarchy of clean rooms and these processes could be in an early stage , but the shops that I have visited have done the processes you named not under filtered positive air pressure containment, but rather out in the shop.

my experience.

milo