Strapped for Validation Resources? 4 Options to Save on Mapping Studies

Janice Bennett-Livingston
May 29, 2014
Industrial Measurements
Life Science
Science & Sensing Technologies

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?

 

BLOG-IMAGE-Vaisala-sample-freezer-temperature-mapping



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:

  1. Remap every 1 to 3 years. So maybe you can push it out to a 3-year frequency.
  2. When remapping, use fewer sensors.
  3. When remapping, map for a shorter duration.
  4. 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

k, 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

 

Contributors

Paul Daniel, Senior Regulatory Compliance Expert

Paul Daniel

Senior Regulatory Compliance Expert

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.

Janice Bennett-Livingston

Marketing Manager

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.

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