Why Your Freezer Fails: A Validation Tale

I recently attended a webinar about temperature mapping validations, and it reminded me of an unusual challenge I faced. A new lab was being set up to test an expanding range of products. The lab required two incubators with rollers, a refrigerator, and a freezer. The incubators and the refrigerator passed validation without any issues, but the freezer kept failing.

Upon troubleshooting, we examined the overall setup and identified the problem. The two incubators were full-floor models and were positioned at the ends. The refrigerator and freezer, which were smaller and sat on the floor, were placed between them. The refrigerator's controller had enough energy displacement to compensate for the heat from the nearby incubators, but the freezer couldn't manage.

Once we moved the hot units away from the cold ones, the freezer passed the validation successfully. This experience serves as a reminder that validation is not just about compliance. It's also a way to optimize processes to ensure long-term reliability.

Don't let a simple oversight derail your validation efforts. Reach out to Brayearst Validation Consulting today and ensure your processes are not just compliant, but optimized for success.

Previous
Previous

Mastering Startup Success: Navigating FDA Rules

Next
Next

The Double Meaning of Validation