Validating Static and Dynamic Conditions & Finding Problem Areas Janice Bennett-Livingston Published: Sep 3, 2014 Industrial Manufacturing and Processes Life Science In this week's blog, I answer some questions on the necessity for mapping under both static and dynamic conditions, what criteria to use for finding hot spots, or problem areas, and how to set up sensors to capture representative data on the conditions of the entire area.
HI Paul, I recently read the article "5 Frequently Asked Questions about Temperature and Humidity Validation/Mapping" and found it very useful! However, I have a couple of questions I'm hoping you can answer...In our plant we are maintaining the temperature of our powder processing area < 25°C and Humidity < 65%. My questions: Is temperature mapping required both "at rest" and "in operation"? For identification of problem areas where temperature or humidity is too high or low, what criteria do we use? Finally, we have data loggers placed along the walls. What about the center area of the room? Thank you, J HI J, Thank you for reading our application note! If you like, we also offer several recorded webinars on validation – here. I am happy to try to answer your questions I hope I have answered your questions! Please don't hesitate to contact me if you have further questions. Best regards, Paul Daniel Is temperature mapping required both "at rest" and "in operation"? 1. It's the presence of product, rather than the operational state of the area that is important in deciding whether or not to map an area. So, is product present or stored in the Powder Processing area (at ambient conditions) during the "at rest" times when no one is working? If no, then there's no need to map at rest. If yes, then you need to map at rest. However, if the conditions in the area are not significantly different when active than at rest, other than the fact that people are present and working, then you can probably treat them the same, and map just at rest because it is easier. Unless (and this is an important point) you are concerned about humidity. When considering a major difference between staffed areas versus areas that are empty of people, remember that people generate humidity. This means people are a significant factor causing the "in operation" phase to have different conditions than the "at rest" phase. Generally speaking, when we are talking about mapping a warehouse, mapping studies include times when the warehouse is in operation and times when people are not working, such as on a weekend. Sometimes, we refer to this as "Static" and "Dynamic" periods. When we are mapping chambers (like a refrigerator or freezer) usage has a large impact on chamber conditions. And because door openings and size of load greatly impact temperature, we recommend both empty and loaded to mimic the conditions of use. Also, it is common to do studies to evaluate the impact of the temperature uniformity caused by opening doors to the small chambers. For identification of problem areas where temperature or humidity is too high or low, what criteria do we use? 2. I would expect that you would use the criteria independently, but luckily, the criteria aren't independent. Temperature is related to humidity because hot air has the capacity to hold more water. Therefore, a warmer area will have a lower RH than another spot with a lower temperature but the same amounts of absolute moisture in the air. Or to say it another way, your high RH areas will likely be cold areas. Finally, we have data loggers placed along the walls. What about the center area of the room? You may need to place loggers in the center areas of the room, especially while you map. What the Regulations say about sensor placement: The European Commission "Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use" "Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations." If you map only along the perimeters of an area, you can't tell if there are any extreme fluctuations away from the wall. However, there may be vents or equipment that causes hot or cold spots within the area. You've already read our "5 FAQs on Validation/Mapping" so you know we refer you to the ISPE's document: ISPE Good Practice Guide: Cold Chain Management," which recommends that for areas ≤ 2m3, use 9 + 1 sensors (nine at periphery and one in the middle); for areas ≤ 20m3, use 15+1.
Is temperature mapping required both "at rest" and "in operation"? 1. It's the presence of product, rather than the operational state of the area that is important in deciding whether or not to map an area. So, is product present or stored in the Powder Processing area (at ambient conditions) during the "at rest" times when no one is working? If no, then there's no need to map at rest. If yes, then you need to map at rest. However, if the conditions in the area are not significantly different when active than at rest, other than the fact that people are present and working, then you can probably treat them the same, and map just at rest because it is easier. Unless (and this is an important point) you are concerned about humidity. When considering a major difference between staffed areas versus areas that are empty of people, remember that people generate humidity. This means people are a significant factor causing the "in operation" phase to have different conditions than the "at rest" phase. Generally speaking, when we are talking about mapping a warehouse, mapping studies include times when the warehouse is in operation and times when people are not working, such as on a weekend. Sometimes, we refer to this as "Static" and "Dynamic" periods. When we are mapping chambers (like a refrigerator or freezer) usage has a large impact on chamber conditions. And because door openings and size of load greatly impact temperature, we recommend both empty and loaded to mimic the conditions of use. Also, it is common to do studies to evaluate the impact of the temperature uniformity caused by opening doors to the small chambers.
For identification of problem areas where temperature or humidity is too high or low, what criteria do we use? 2. I would expect that you would use the criteria independently, but luckily, the criteria aren't independent. Temperature is related to humidity because hot air has the capacity to hold more water. Therefore, a warmer area will have a lower RH than another spot with a lower temperature but the same amounts of absolute moisture in the air. Or to say it another way, your high RH areas will likely be cold areas.
Finally, we have data loggers placed along the walls. What about the center area of the room? You may need to place loggers in the center areas of the room, especially while you map. What the Regulations say about sensor placement: The European Commission "Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use" "Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations." If you map only along the perimeters of an area, you can't tell if there are any extreme fluctuations away from the wall. However, there may be vents or equipment that causes hot or cold spots within the area. You've already read our "5 FAQs on Validation/Mapping" so you know we refer you to the ISPE's document: ISPE Good Practice Guide: Cold Chain Management," which recommends that for areas ≤ 2m3, use 9 + 1 sensors (nine at periphery and one in the middle); for areas ≤ 20m3, use 15+1.
Contributors Paul Daniel, Vaisala Senior GxP Regulatory Compliance Expert Paul Daniel has worked in the GMP-regulated industries for over 25 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor’s degree in biology. Connect on LinkedIn Janice Bennett-Livingston Marketing Manager Email [email protected] In addition to editing the Vaisala Life Science blog, Janice Bennett-Livingston is the Global Life Science Marketing Manager for Vaisala's Industrial Measurements business area. Pre-Vaisala writing credits include a monthly column called "Research Watch" for Canada's award-winning magazine alive, as well as articles in Canadian Living and other periodicals. Other past work: copywriting for DDB Canada, technical writing at Business Objects, and communications specialist for the British Columbia Child & Family Research Institute.
Paul Daniel, Vaisala Senior GxP Regulatory Compliance Expert Paul Daniel has worked in the GMP-regulated industries for over 25 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor’s degree in biology. Connect on LinkedIn
Janice Bennett-Livingston Marketing Manager Email [email protected] In addition to editing the Vaisala Life Science blog, Janice Bennett-Livingston is the Global Life Science Marketing Manager for Vaisala's Industrial Measurements business area. Pre-Vaisala writing credits include a monthly column called "Research Watch" for Canada's award-winning magazine alive, as well as articles in Canadian Living and other periodicals. Other past work: copywriting for DDB Canada, technical writing at Business Objects, and communications specialist for the British Columbia Child & Family Research Institute.
