Strapped for Validation Resources? 4 Options to Save on Mapping Studies Janice Bennett-Livingston Published: May 29, 2014 Industrial Measurements Life Science In this week's blog, Paul answers some questions from a webinar attendee on how often you NEED to remap a qualified area...
HI Paul, I attended a webinar you presented last year and learned a lot, thank you! I am the Validations Specialist at a medical device company. Approximately 2 years ago we completed thermal mapping on all of our equipment and storage areas (incubators R, Thanks for attending our webinars! Great question! Here are my thoughts (with options listed): Revalidation is expected. This is simply because equipment wears out, especially in refrigerators and freezers. The compressors get old, the refrigerant breaks down, and the insulation and door seals harden and become less effective over time. Therefore, the process you measured – the temperature uniformity of a storage environment – will change over time. This is true despite our efforts at change control, preventive maintenance, etc. It is good that you have a validated monitoring system, likely monitoring a single point in each chamber. That point was chosen, either because it was a hot/cold spot, or because it was representative of the conditions in the unit, etc. To rely on just the monitoring data (and not revalidate) is to assume that the temperature dynamics inside the chamber haven’t changed. But, realistically, we can’t be certain this is true. So, we are stuck with the need to revalidate. In reality, what we need is to show that the process is still operating in a state of control, in this case, with temperature uniformity. Is remapping every 2 years the only way to do this? Here’s what I have seen done at other facilities. I’m not telling you to do this, but just sharing it as an example of other’s approaches to mitigating risk, while managing the costs of remapping: Remap every 1 to 3 years. So maybe you can push it out to a 3-year frequency. When remapping, use fewer sensors. When remapping, map for a shorter duration. Analyze the Building Monitor data for each unit annually, to look for signs of “wear and tear,” such as longer cycling periods. Then when the Building Monitor data indicates a great enough change, remap. Hopefully, one of these strategies works for you to reduce the amount of work you have ahead of you. Best regards, Paul Daniel Thank you for your response. But, one more question… If we go with option 4 and review the building monitoring data every year, do you still recommend mapping every 3 years if the analysis is good and no change is observed? Thanks again! R OK then, I should elaborate on option 4 a bit, because it’s tricky, especially if you want to use it to justify not remapping at all. I did work at a particular company that would actually analyze the graph to see how the frequency (and/or slope of the cooling/warming phases) changed over time. A slower cool-down could be indicative of compressor or refrigerant wearing out. A faster warm-up could be indicative of the degradation of door seals and insulation. When the change was great enough, they would remap. Unless you have the background data and the science to back up your assumption that the building monitor data is an accurate indicator of changes in freezer (or other unit) performance, I would not rely wholesale on Option 4. You could do a lighter version of option 4, where you simply do an annual review to investigate the number and frequency of alarm events, as well as an alarm test. Then if that data looks good, move your revalidations out to 2 or 3 years, and use Options 2 and 3 – mapping for less time with fewer sensors. Again, you will need to decide what works for you. I am sharing what others have done, but their circumstances may have been quite different. Good luck! Best regards, Paul Daniel
HI Paul, I attended a webinar you presented last year and learned a lot, thank you! I am the Validations Specialist at a medical device company. Approximately 2 years ago we completed thermal mapping on all of our equipment and storage areas (incubators R, Thanks for attending our webinars! Great question! Here are my thoughts (with options listed): Revalidation is expected. This is simply because equipment wears out, especially in refrigerators and freezers. The compressors get old, the refrigerant breaks down, and the insulation and door seals harden and become less effective over time. Therefore, the process you measured – the temperature uniformity of a storage environment – will change over time. This is true despite our efforts at change control, preventive maintenance, etc. It is good that you have a validated monitoring system, likely monitoring a single point in each chamber. That point was chosen, either because it was a hot/cold spot, or because it was representative of the conditions in the unit, etc. To rely on just the monitoring data (and not revalidate) is to assume that the temperature dynamics inside the chamber haven’t changed. But, realistically, we can’t be certain this is true. So, we are stuck with the need to revalidate. In reality, what we need is to show that the process is still operating in a state of control, in this case, with temperature uniformity. Is remapping every 2 years the only way to do this? Here’s what I have seen done at other facilities. I’m not telling you to do this, but just sharing it as an example of other’s approaches to mitigating risk, while managing the costs of remapping: Remap every 1 to 3 years. So maybe you can push it out to a 3-year frequency. When remapping, use fewer sensors. When remapping, map for a shorter duration. Analyze the Building Monitor data for each unit annually, to look for signs of “wear and tear,” such as longer cycling periods. Then when the Building Monitor data indicates a great enough change, remap. Hopefully, one of these strategies works for you to reduce the amount of work you have ahead of you. Best regards, Paul Daniel
Thank you for your response. But, one more question… If we go with option 4 and review the building monitoring data every year, do you still recommend mapping every 3 years if the analysis is good and no change is observed? Thanks again! R OK then, I should elaborate on option 4 a bit, because it’s tricky, especially if you want to use it to justify not remapping at all. I did work at a particular company that would actually analyze the graph to see how the frequency (and/or slope of the cooling/warming phases) changed over time. A slower cool-down could be indicative of compressor or refrigerant wearing out. A faster warm-up could be indicative of the degradation of door seals and insulation. When the change was great enough, they would remap. Unless you have the background data and the science to back up your assumption that the building monitor data is an accurate indicator of changes in freezer (or other unit) performance, I would not rely wholesale on Option 4. You could do a lighter version of option 4, where you simply do an annual review to investigate the number and frequency of alarm events, as well as an alarm test. Then if that data looks good, move your revalidations out to 2 or 3 years, and use Options 2 and 3 – mapping for less time with fewer sensors. Again, you will need to decide what works for you. I am sharing what others have done, but their circumstances may have been quite different. Good luck! Best regards, Paul Daniel
