In this week's blog, we feature two questions our regulatory expert Piritta Maunu received on environmental qualification. Piritta describes why placing an external sensor outside storage areas is important, and outlines a method for reducing the number of sensors in thermal validation of large spaces.
Dear C,Thank you for joining our webinar and thank you for emailing me your excellent question:"Do you suggest also locating a mapping sensor external to the warehouse i.e. outside to assess the challenge during the study?"
Yes, we definitely suggest to locate one sensor at ambient conditions outside the warehouse. This is really important, as you already seem to understand, in case you have some fluctuating mapping results or even out of specification (OOS) mapping results inside the warehouse. When you have one sensor outside the warehouse you are able to understand a bit more of the "big picture" of your warehouse.
I hope my answer is helpful and if you have further questions, please don't hesitate to contact me again.
Best Regards,Piritta Maunu
Dear A, Thank you for joining our webinar and forwarding your question: "Please repeat how you reduce sensor quantity?" Usually, when we talk about warehouses we mean large areas. So in mapping an area ≥ 20 m3, reducing sensor density can save a significant amount of money and effort.
There are a couple approaches to reducing the number of sensors. You could do it by mapping only the locations where the product is stored (shelves, racks). Or… by using in the three-dimensional (3D) area stacks of three sensors - but in practice, you remove every other sensor. From a presentation my colleague Paul Daniel gives on this method, please see the following three images:
The maximum distance between the "stacks of three" shouldn't be more than 15-25 meters (RT, room temperature) or 5-8 meters in cold storage areas (+2…+8˚C).
Hope that this answer is helpful
Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 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 also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.
Piritta Maunu has 15 years of experience in biotechnology, having worked in several quality management positions. Maunu holds a degree of M.Sc. (Cell Biology) and is certified to teach with a specialty in General Biology, both degrees from the University of Jyväskylä, Finland. In her role at Vaisala, she supports the sales department, assists the quality department with audits, creates educational content for life science customers, and provides application support to R&D teams creating solutions for monitoring critical environments.