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Lyophilizer Calibration
Due to heightened quality requirements from regulatory bodies such as the FDA, from customers and from internal quality assurance guidelines, equipment calibration is more important than ever. As an FDA-regulated company, you may be audited for your compliance with FDA regulatory requirements - either GLP (Good Laboratory Practices) or GMP (Good Manufacturing Practices). The FDA requires that the display accuracy of all instruments that have an effect on the quality of your product be verified (calibrated) over a specified interval of time.

Lyophilizing systems are comprised of many vital components including temperature probes, vacuum gauges and cycle timers. It is of utmost importance to ensure that critical parameters of the lyophilization process are monitored and controlled accurately. Unnoticed excursions can have a serious effect on the quality of your product whether it be cell culture or clinical assay.

Biometrix provides on-site lyophilizer calibration using high accuracy, NIST traceable temperature, humidity, and pressure calibration standards.

  • Our PRTs (Platinum Resistance Thermometers) uphold industry leading accuracies of up to 0.025 degrees Celsius.
  • Our humidity probes uphold industry leading accuracies of up to 0.2 %RH.
  • Our pressure calibrators uphold industry leading accuracies of 0.05% (full scale).

This level of accuracy ensures 4:1 accuracy ratio compliance, even for customers who maintain the most stringent process tolerances. Upon completion of calibration, Biometrix technicians will leave you with detailed calibration certificates, with information on as-found data, as-left data, test point deviations, instrument tolerance and instrument operating range.

Our technicians have experience with a vast array of lyophilizers and can provide you with the high quality service that you demand. Our ultimate goal is to leave you with the peace of mind that your equipment is performing its role properly and accurately.