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The Importance of Calibration (Part 1)

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In the Pharmaceutical and Life Science industry calibration is an important topic that is almost always coupled with purchase of analog and digital probes, software, and hardware.  The most common questions are how does calibration and re-calibration work?  What is the recommended calibration interval?  What is the difference between analog and digital probes?  All these questions are very important in deciding what is needed for calibration of integral or critical systems within any pharmaceutical and life science facility.

What is Calibration?

Calibration is the comparison of measurement values delivered by a device under test with those of a calibration standard of known accuracy.  The accuracy of the instrument is how close or accurate the value is according to a process value recorded from the instrument.  An example is a temperature probe that when purchased from a vendor has a reading temperature range of 0.0-100.0°C (tolerance of 0.1) with an accuracy of ± 0.5°C.  If the probe had a reading of 25.0°C, then the reading could be anywhere from 24.6°C to 25.4°C.  To test this accuracy of this temperature probe, a test standard or reference standard is needed to compare values.  Test or reference standards are very accurate and are always NIST certified of NIST traceable  instruments.
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Why is Calibration Important?

 
A question many people ask is why do I have to calibrate this probe or sensor as it was calibrated when I bought it?  Well, that is true most vendors with ISO 17025 accredited labs calibrate probes or sensors before being sent to the customer.  The issue is that the probes and sensors accuracies tend to drift over time.  A year from the now the accuracy of a calibrated sensor can change dramatically.  It is extremely important to check that calibration on a period basis depending on assigned criticality of the instrument within the facility.  That calibration interval or period can be one year or six months depending on the facilities quality management assigned criticality to processes.
 
Tune in next week for what happens when your calibrated instruments become no longer within calibration...
 

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