Contagem de partículas em laboratórios farmacêuticos ou de ciências biológicas

• We have installed and validated a continuous particle monitoring system from Particle Measuring Systems. Now we are struggling with the question how to deal with isolated excursions. We are using IsoAir Plus sensors sampling for 1 minute. What is your experience/recommendation?
• Where should I place the sample points for non-viable particle monitoring performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.)?
• I have a question for you about setting up the Pharmaceutical Network software for use with the portable units in our clean room facility. Wifi will not be an option at this time, but we are pursuing the option of direct connection to the network. If we run a cable into our clean room to download the data from the portable particle counters, is it necessary to have a dedicated computer at the same location to receive the data, or can the data transfer directly to any computer that contains the software?
• Do you have any new information on foreign particle detection and limits for dry powder inhalers. I am current on the FDA's lack of momentum but looking to see if you could offer an insight on global work in this area or domestic work that I may not have seen.
• I am trying to find copies of guidelines from the FDA or related documents about what the safe cutoffs are for IV solutions etc. I am an in vitro biochemist. I have been using a nephelometer to determine solubility of some compounds but I have some concerns about how accurate this approach will be.
• EU GMP Annex I was going to revise the acceptance criteria for Class A area (for non-viable particle count) from <1 to probable 10 or 20 particles. WHat is the status of this? Can you please inform wheter whether this has revisd and released or not? If not published then when it expected to be released.