FAQ Pharmaceutical/Life Sciences Particle Counting

• When sampling a room to do a room qualification with the Lasair particle counter, 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 once at 5 um. Correct?
• During revalidation, is it mandatory to particle count for 3 consecutive days in laminar air flow unit & as well as in area qualification?
• If performing particle counting with tubing connected to the isokinetic probe, is there a suggested timeframe to change the tubing due to possible particle hold up?
• 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?
• What do we need to do to validate the software for use in a Pharmaceutical GMP environment?
• How does the Lasair II 550L calculate the # of particles per sample volulme?
• What is the requirement / recommendations for tube length for particle counters
• What is the non pathogen particle size limitation in IV injectable solution?
• What is the recommended recovry time for oral solid dosge form manufacturing facility?
• How many locations do we need for ongoing routine particle count tests?
• What is the particle count frequency for new facilities under validation?
• 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.
• 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?
• Is there a standard or specification for monitoring particules from an oil free air compressor which is used in contact with pharmaceutical products?
• We are filling an opthalmic product under ISO 5 and measuring particle counts every minute. Occasionally. particle counts are going beyond limits (more than 100 particles) .Automatically, it comes down subsequently. Does a rise in particle counts means the system has gone out of control? What should be done to avoid this? How do we address such incidences so that there will not be any 483?
• How does the IQ/OQ validation differ from calibration?
• Do we have to perform method validation if we were to use air particle counter for monitoring? Or can we just depend on the instrument's IQ/ OQ documentation + the calibration certificate?
• Why monitor for 0.5um & 5.0um particle?
• Please provide a very brief overview of the supporting information we can use to prove compliance.
• Specifically, what is the number of leak tests per year, velocity, cleanliness, and other items required for HVAC Systems?
• What is the certification frequency required for HVAC Systems?
• In the case of gowning rooms, airlocks. Which must be the suitable height to place the sample of the particle counter?
• 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.
• 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.
• 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.)?
• When will USP 797 become effective?
• How will USP 797 be enforced?
• 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?
• What is the difference between validation and certification of cleanrooms?
• Are you aware of any studies or technical papers on the particulate impact of wearing certain types of clothing, such as jeans, corduory clothing, etc. when wearing lab coats?
• 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?
• Per ISO, statistical analysis is required if the number of locations to be measured are (as the area calculated) >2 and < 9. If, based on my area, the number of locations to be sampled are 7, can I perform counting at extra locations (up to 10) and avoid the statistical analysis?
• 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?
• 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.
• Is the APSS-200 suitable for aqueous and non-aqueous solutions?
• 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?
• Regarding non-viable particle counts in clean area (aseptic processing), does FMS continue monitoring during production where powder filling is done?
• Are there any industry guides or regulatory requirements for continuous monitoring during sterile dry powder processing line?
• What should the height be for particle sample collection in powder filling process?