符合欧美和中国新版GMP的环境监测方案-MrJoe Gecsey.ppt

So what about powders? The Annex 1 says that it is sufficient to monitor the critical zone just prior to turning the fill machine on. Then, move the probe outside of the area of interference. Also, monitor simulations to manage the risk. This shows the strategy And again. This shows the strategy This shows the strategy The calculate the proper opening for a different laminar flow rate or a different counter rate, the formula is determined by Q = A x V where Q is the flow rate of the counter, A is the area of the probe opening, and V is the velocity of the laminar air flow. Because the area, A, is equal to (? r2), the formula reduces to Q = (? r2) x V or For English units of Flow (Feet per Minute), Volume (Cubic Feet per minute) and for the radius in inches, the formula reduces to ? V ? r = Q V ? r = 6.77 Q * What the EU Annex 1 says about monitoring … continuous * * * ISO 14644-1 establishes standard classes of air cleanliness for cleanrooms and clean zones based on specified concentrations of airborne particulates. An ISO Class 1 cleanroom has no more than 10 particles larger than 0.1 μm in any given cubic meter of air. An ISO Class 2 cleanroom would be ten times dirtier than a Class 1 cleanroom, and an ISO Class 3 cleanroom would be ten times dirtier than a Class 2, and so forth. The specific allowable particle limits per ISO Class are shown in the Table. An ISO Class 5 cleanroom is equivalent to a FS 209E Class 100. In the next few slides we will discuss how this relates to the requirements set forth in the EU GMP Annex 1. But, take note of the values for particles at 0.5 um and 5 um for an ISO Class 5 cleanroom. ISO 14644-1 establishes standard classes of air cleanliness for cleanrooms and clean zones based on specified concentrations of airborne particulates. An ISO Class 1 cleanroom has no more than 10 particles larger than 0.1 μm in any given cubic meter of air. An ISO Class 2 cleanroom would be ten times dirtier than a Class 1 cl