I have just reviewed your webinar “Environmental Mapping - Temperature Mapping Protocols.” There was one slide that talked about “recording ambient conditions,” which made me think about an issue we have…
We are implementing a reefer truck (located outdoors by the loading dock) to handle storage of overflow finished goods. We plan to validate the reefer truck in the same way as we would a walk-in cooler (temperature specification 2 – 8°C and located indoors).
First, there is a potential long-run problem because we are located in very cold climate (Eastern Canada). Secondly, how would recording ambient conditions work in the validation of the reefer truck? Would seasonal temperature mapping be something you'd recommend in this case? Thank you very much for your advice!
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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.
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.