contamination in class 100 000 cleanroom and gowning
contamination in class 100 000 cleanroom and gowning
(OP)
I am investigating a contamination problem with a class 100000 clean room for a Medical devices plant.I would like to know what is the recommended air change per hour for a class 100 000 cleanroom and its gowning area and where would i find the information to back this up.Also as there is increased traffic in the cleanrooms is there any way to counteract the associated increase in contamination.
I would greatly appreciate any help from any of you out there.Thanks in advance!
I would greatly appreciate any help from any of you out there.Thanks in advance!





RE: contamination in class 100 000 cleanroom and gowning
Whyte's book on cleanroom technology can be a good reference if you want these figures in black and white (for a cover up.
There are some smart(!?)garment manufacturers out there, who make garments with a claimed filtration level (I saw a numeric as high as 99.7%). May be, you can try out.
RE: contamination in class 100 000 cleanroom and gowning
RE: contamination in class 100 000 cleanroom and gowning
Try to do particle count at a no of places and you will know whether the problem is widespread or limited to few locations only.
RE: contamination in class 100 000 cleanroom and gowning
RE: contamination in class 100 000 cleanroom and gowning
I've seen some really stupid things, like people dressing up in Halloween makeup in a Class 100.
TTFN
RE: contamination in class 100 000 cleanroom and gowning
The ASHRAE HVAC Applications handbook also provides a good cursory review of clean room guidelines.
RE: contamination in class 100 000 cleanroom and gowning
http://www.set3.com/index.html
RE: contamination in class 100 000 cleanroom and gowning
Class C areas (class 10000 at rest and class 100000 in operation) are specified with a TVC limit of <100cfu/m3 when you are using an air sampler. However, this is not sufficient to establish your viable data. You have to simulatneously take settle plate counts as well. With settle plates of 90mm dia. with an exposure time of 4 hours, the count should be less than 50 cfu. Your count seems to be in limit.
If at all, the problem intensifies, do fumigation once. If you have reservations for formaldehyde, check for Minntech for their disinfectant fogger system.
Have a look at your cooling coils. They are the eternal breeding grounds for living organism.