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In accordance with industry standards and best practices outlined by ISPE, USP, and WHO, I suggest a risk-based protocol for temperature sensor placement, focusing on critical risk assessment to define sensor locations. Before jumping into specific guidelines to determine sensor locations, it is imperative to apply a risk-based approach to define these placements. This assessment aids in evaluating risks to determine sensor placement priorities effectively. Here are some guidelines for sensor number and placement are as follows: ?? For chambers up to 2 cubic meters: ? Utilize 10 temperature sensors. ? Place 9 sensors within the usable volume of the chamber ? ensuring a comprehensive spatial temperature profile. ╰? As illustrated in Figure 1 ? Position an additional sensor in close proximity to the probe of the device that monitors and/or controls the chamber for correlation purposes. ?? For chambers up to 20 cubic meters: ? Utilize 16 temperature sensors. ? Distribute 15 sensors within the usable volume, ensuring that the extended dimensions of the chamber are adequately monitored, especially at the center of each pane, which may exhibit different temperatures from the corners due to its position. ╰? Align with the configuration shown in Figure 2 ? Include an additional sensor near the monitoring/control probe for correlation purposes. ?? For large facilities: ? Arrange sensors in a grid pattern, spacing them every 5 to 10 meters across the facility's width and length. For exceptionally large spaces, consider placing sensors up to 20 or 30 meters apart, based on a risk assessment that considers the unique environmental characteristics and the products stored. ? Create multiple vertical layers of sensors, increasing the number of layers proportionally for higher ceilings. ? Place an extra sensor adjacent to the HVAC system's monitoring/control probe(s). ? Focus on mapping product storage areas exclusively, and provide a clear rationale for placing sensors in any additional areas of interest. ? Incorporate external temperature monitoring to evaluate ambient influences, ensuring comprehensive risk assessment and optimized temperature control strategies. These guidelines are derived from the following references: ?? ISPE (2021). Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring. ?? USP (2018). USP41-NF36 <1079>. Good Storage and Distribution Practices for Drug Products. ?? World Health Organization (2015). Technical Supplement 8 to WHO Technical Report Series, No. 961, 2011. Temperature Mapping of Storage Areas. These guidelines should serve as a foundation and are adaptable to your facility's needs, considering unique environmental characteristics for accurate mapping and resource optimization while maintaining product integrity and safety. If you need any further clarification or assistance, please feel free to DM me. Always Here to Help. ? P.S. Repost ?? this for others too!
Nathan Roman ?? For those who unfortunately couldn't make it to your ISPE webinar yesterday, is there a way we can watch it? With such great feedback, I'd love the opportunity to watch it too. Thanks :)
The only addition I would make is to make sure we are understanding the applicability of the guidance. Yes there are similarities, there are big differences as to when they should be referenced. WHO in particular is not something a manufacturing facility should use. Interestingly enough it is the only guidance that speaks to penetration studies. Sadly there are many in the industry that think penetration studies are a basic qualification requirement......
Awesome summary Nathan Roman ?? . Thanks for sharing. You are spot on regarding general guidance as always! To add to this general concept I would also consider placement of sensors near or around the evaporator fan outlets (when systems are equipped with them). Particularly so for smaller chambers where material placement in these areas may not be able to be avoided easily. The temperature of the air coming out of these fans is often much colder (typically below freezing) in order for the rest of the room to achieve the desired distribution temperature range. On occassion if material is stored too close to the fan outlet it can actually partially freeze. For those of you who have has ice crystals in your milk from storing in your refrigerator at home in the back, you know what I’m talking about! ?? Understanding the heat transfer, mechanics, and thermodynamics of how the unit operates is critical to ensure proper temperature distribution placement during mapping. Good stuff! Thanks again Nathan Roman ??!
Thank You Nathan for this clear and précious explanation . One question : what would be your recommandation if man wants to monitor the température change on large ground field ( i.e 1km2) with a precision of 0,01?
Great Post Nathan. What are your thoughts and considerations for mapping receiving and shipping bays in large finished product warehouses.
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Temperature Mapping & Validation Expert | Temperature Mapping Got You Stressed? | Let Me Help | Book a call from my Featured section anytime | Want more posts on Temperature Mapping & Qualification? ? Be Sure to Follow
1 周?? Love reading back over these discussions on risk-based sensor placement! Thanks for all your comments. Temperature mapping isn’t just about compliance—it’s about real-world reliability. Smart sensor placement = fewer headaches later. Risk-based sensor placement shouldn’t be one-size-fits-all. The best strategies adapt to real-world conditions—like seasonal variations, loading patterns & airflow dynamics. Mapping is a science AND an art!