I want to know why do we measure only 0.5 and 5 micron particle sizes for classification of clean rooms?
By both of these we can estimate the cleanliness of the area. We don’t need to measure the particles between these sizes.
0.5 micron is smallest size particle required for carrier to microbes.particle larger than 5.0 micron can settle easily due to gravity so it is not good carrier for microbes.
Thank you for your reply. and what about measuring 10 micron and 25 micron particles in liquid parentrals as particulate matter? and then, why they are not measured in oilly parentrals?
Health risk associated with particulate matter are pulmonary embolism,infarction,death.it depends on particle size,shape and number.diameter of blood capillaries is 6 to 8 micron.diameter of vein increases in direction of blood flow and diameter of artery decreases in direction of blood flow.large size particles are trapped in lung but small size particles goes to spleen,liver via pulmonary arteries and affect the organ.
Visual inspection of oily product should be performed.
1- as we know, it takes at least 48 to 72 hours until we get the results of water tests. if we realize that the water which the product is mixed with,is contaminated, what do we have to do? I mean what is the corrective action?
2- media fill should be conducted in a sterile production line every 6 month and for 3 times. I want to know that how do these 3 times should be done? I mean in 3 consecutive days without any waiting for the results or start the second part after 14 days of getting the results of the first media fill?
logical and documented answers, please!