European Guidance Round UP for Vaccine Storage, PLUS European Webinar Announced! Piritta Maunu Life Science Regulatory Compliance and Industry Expert Published: Feb 13, 2015 Life Science Hello J/ Thank you for your question: "Who regulates the procedures in Europe or globally as opposed to NIST or CDC (US based)?" related to vaccine storage (or storage of TTSPPs = Time and Temperature-Sensitive Pharmaceutical Products) in EU. In Europe the regulations related to your question are found here: EU GMP Volume 4 EU GDP (2013/C 343/01) PIC/S, PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME, PE 009-11 (Annexes) 1 March 2014 In addition to that, here are some excellent references listed below: WHO Technical Report Series No. 961, WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS. Temperature and humidity monitoring systems for fixed storage areas, Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products, August 2014 Qualification of temperature-controlled storage areas Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products January 2014 ISPE Good Practice Guide: Cold Chain Management (2011). "It is a common practice to use a defined time delay on temperature alarms, or to mount the sensor in vessel containing a thermal fluid to simulate the damping effect of the packaging on the packaged product in response to changes in local air temperature, where this practice is used there should be data to show the system is representative of the packaging system temperature response." All of these resources are crucial to understanding current best practice and regulatory expectations. I hope this helps! If you have any further question, please don't hesitate to ask.
Our Sensor Placement Webinar on Greenwich Mean Time 25 March 2015 Time: 3PM London / 11 AM New York This 1-hour webinar is a tutorial on sensor placement for environmental mapping qualification comprising 5 simple rules. These rules are based in 17 years of mapping experience in regulated environments. Watch now
Also... regarding an earlier blog where we discussed "damping" of probes. In the ISPE Guide (page 75) they say the following about "Damping": Read more about the subject
Bonus Q & A – How many sensors for Mapping rooms shaped like an "L" Dear Piritta, We have to map an area shaped like an L. How would you place the sensors here? Thanks for your help! /D Dear D, I recommend that you map these two areas separately. I think you have two options: Option 1 – In practice, use the 9+1 rule for both areas. Place one sensor in the center, 8 in corners + 1 representing the sensor location of the monitoring system. For an L-shaped area maintained between +2…+8˚C, if you are uncertain of problem areas, you should map all of the corners separately. That will require 13 + 1 sensors. Option 2 - It IS possible to map this L-shaped area using 11+1 sensors by eliminating the center "corner" sensor (marked in the drawing above with a circle). Here the sensor you will place in the center of the room is close enough to capture this area.
Dear Piritta, We have to map an area shaped like an L. How would you place the sensors here? Thanks for your help! /D Dear D, I recommend that you map these two areas separately. I think you have two options: Option 1 – In practice, use the 9+1 rule for both areas. Place one sensor in the center, 8 in corners + 1 representing the sensor location of the monitoring system. For an L-shaped area maintained between +2…+8˚C, if you are uncertain of problem areas, you should map all of the corners separately. That will require 13 + 1 sensors. Option 2 - It IS possible to map this L-shaped area using 11+1 sensors by eliminating the center "corner" sensor (marked in the drawing above with a circle). Here the sensor you will place in the center of the room is close enough to capture this area.
Author Piritta Maunu Life Science Regulatory Compliance and Industry Expert 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.
Piritta Maunu Life Science Regulatory Compliance and Industry Expert 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.
