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• Wehn sampling a room to do a room qualification with the Lasair II, at what height should the samples be taken? Close to the floor or at working height?
• When performing a room-qualification for 0.5 micron as well as for 5 um particles: In order to avoid doing it twice - one should do it at 5um. Correct?
• During revalidation, is it mandatory to carry out particle monitoring for 3 consequitive days in laminar air flow unit & as well as in area qualification ?
• Which is the suitable classification for clean rooms in hospitals? Is there any classification that gives the category of ISO for rooms such as "operating theatres", "isolation room", "intensive care room", etc?
• How many locations do we need for ongoing routine particle count tests?
• We are setting up a manufacturing facility which will have areas specified with particle concentaration limits as per ISO 8. The system is ready for validation. Which guidelines should be followed before starting the particle count tests.
• What is the particle count frequency for new facilities under validation?
• Regarding GMP annex 1."For routine testing the total sample volume should not be less than 1 m3 for grade A and B areas and preferably also in grade C areas", 1) What iss the meaning of the word "Areas"? Is it for the cleanroom area or the sampling point? 2) If we have grade B class and it is 16m2 in surface, we will have 4 sample location. How much sample volume do we have for each location?
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• Please provide a very brief overview of the supporting information we can use to prove compliance.
• Regarding non-viable particle counts in clean area (aseptic processing), does FMS continue monitoring during production where powder filling is done?
• Regarding non-viable particle counts in clean area (aseptic processing), does SOP spell out for initial and post operation counts and during filling operation on FMS should not collect data?
• A regulatory authority has asked that we monitor at the stopper bowl area of our filling lines on a routine basis. We intend to survey the area around the stopper bowl to find the worst case location excluding the areas that are routinely accessed by operators. We don't intend to monitor zones that are routinely accessed by operators such as the loading of the stopper bowl with stoppers. Does this seem a reasonable approach? Our real poser is what actions should be taken if an action limit is exceeded at the stopper bowl area.
• What should the height be for particle sample collection in powder filling process?
• Are there any industry guides or regulatory requirements for continuous monitoring during sterile dry powder processing line?
• We have a filling line which includes the following elements; vial in-feed turntable, filling, stopper handling and capping stations. I understand that the clean space is required to be certified and qualified however, from your experience and what you observe in industry, how many and what locations are monitored on a routine basis for the filling line application indicated above. For example, is it industry practice that monitoring continuously takes place at the vial in-feed, filling and stoppering zones?
• How do Airnet 510 particle sensors (1 cfm) comply to ISO 14644-1 standard for Class 5 (29 counts per cubic meter @ 5.0 micron)? Currently, we've worked out all sampling intervals to be 25 minutes, in order to achieve 690 Litres of sample air based on the ISO 14644-1 standard for Class 5.
• Is it necessary to monitor for non-viables at the capping station on a batch by batch basis? The product entering the capping station is filled and stoppered. There is a school of thought that the capping station should be monitored as there may be a risk that the stopper may not be fully seated as it enters the capping machine/station. Monitoring at the capping station can be a problem as the capping activity is an inherent particle generating operation.
• More and more pharmaceutical companies in France tend to sample a cubic meter per point for qualification purpose in grade A, B and sometimes C. If you have some fresh inputs from leading pharmaceutical industries in teh US or the best directly from the FDA please share them.
• Where should I place the sample points for non-viable particle monitoring performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.)?
• 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?
• 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.
• 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?
• 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.
• What was the specification implemented in 1986? What was the rationale for this specification?
• Did the specifications actually evolve over time? What were the reasons for tightening the specifications? In particular, why were the specifications lowered from 10,000/1000 to 6,000/600 for 10 μm/25 μm size particulate in 1995?