Manufacturing Medical Devices

So is the idea of a clean room to allow chemical such as cleaners, electro polishing chemicals and acids involved in passivation to be included in the implantable product or assembly as contaminants? or is it's purpose to exclude such foreign substances from contaminating the products? To set up a quarantine for unwanted contaminants?

Have you reviewed

ISO13485:2003 and FDA QSR 21 CFR Part 820 To see what they require?

What level of clean room? Class 10? class 10000? ISO Class 4? ISO class7?

All the shops i've visited or audited have these processes outside the clean rooms.

The clean rooms were used for assembly packaging kitting etc. not wet processes.

milo

What is your question?

Kevin Smith (KSmith@TSTAR.com)