Clean room for medical parts.

[Joe Hillmann]

Right now I am remodeling my shop. As I am doing it I am keeping in mind future tools I would like to add. One thing that I have been thinking about is to build a room that can easily be converted to a clean room in the future if I get into any food or medical parts.

I have worked at factories before that made medical parts and the procedures verified depending on the part made. It could be as simple as wash your hands, wearing gloves, wearing gloves a gown and mask, a plastic clean room around the machine with hepa filters, or on some parts a full on pressurized clean room where you had to fully suit up and take two air showers between three doors before entering.

I am thinking in that one room using airtight drywall instillation and then in the future if I get into work where a clean room is needed add some type of hepa filtration to positively pressurize the room. I think that would work for all but the most demanding jobs and for now cost less then $100 extra for doing the airtight drywall.


Does any one here have a clean room set up or do medical or food parts? If so what special precautions do you take?

[Chris DeGerolamo]

We have worked on parts that needed to be sterilized etc before they are used, this is always done once on the customer's end once they leave our shop. Would it not be reasonable to assume the same in your case?

[Dan Hintz]

Medical devices will not go straight from manufacturing to a medical facility... I guarantee there will be (at a minimum) one or more cleaning stages of some form (chemical, autoclave, etc.).

[Joe Hillmann]

Yes the parts are sterilized afterwords but when I worked at factories that hired out work they sent auditors out to where the work was being done to make sure everything was done exactly as it was documented. The documentation were very specific stating what equipment was to be running, where exactly in the facility the operations were to take place. Who had access to the room and on and on. I assume most of the paper work that I saw was for ISO certification so it was made up after the first run was done to describe how any future work should be done rather then to qualify what was required to contract the work.

But even with that said I think having access to a clean room could help land some jobs in the future.

[matthew knott]

We do loads of food items (bar and drink is the biggest) plus medical parts, and this has never ever come up, we have ISO9001, (never sure if that was worth the cost but it made us put some good procedures in place). I doubt it will be a customer requirement, and if it is I doubt that a 'home made' clean room would be up to their requirements. Of course I could be wrong, and if it doesn't cost lots of money then theres no harm in doing it if you want. My advise, if you havent done it, is spend the money getting the rotary for your yag going, thats a service you can sell !
Cheers

[George Brown]

Clean rooms in manufacturing are used to reduce dust and contaminants that would damage parts, not to ensure a sterile work environment.