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What Is Calibration?
Equipment Validation
Depending on whom you ask, there are many di erent answers to the de nition/meaning of FDA Process Validation
calibration, but the basic principle remains the same throughout.
FDA Regulations
To ensure that measurements being made or output provided by equipment are accurate, they
need to be compared against a reference that is known to be accurate. This is exactly what the Feild Services
process of calibration achieves – a comparison between measurements of known and unknown Flow Calibration
accuracy or precision.
Instrument Calibration
When calibration is being done, the equipment with unknown performance is called the ‘unit
IQ OQ PQ
under test’ or ‘test instrument’; and the other is called the ‘calibration standard’ or simply
‘standard’. ISO Audit
Operational Quali catio
Why Is Calibration So Important?
pipette calibration
Calibration is used to de ne the quality of measurement parameters, like accuracy, range or
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precision, which are recorded by a piece of equipment. It’s a necessary part of the process like
manufacturing, testing, and quality assurance, which form the backbone of a wide range of Process Validation
industries and sectors.
Quality Assurance
Here’s an overview of why calibration is important for practically every industry (especially those Quality Compliance Serv
that are heavily regulated by authorities like the FDA) at some point or another:
RS Calibration Hiring
Over time, the quality of measurements of just about every tool will deteriorate to some extent. Companies
need to ensure that these shifts in accuracy are tracked, and measures are taken to prevent them from Temprature Calibration
a ecting nal product quality.
Torque Wrenches Calibr
Equipment that operates on certain technologies, or measures shifting parameters like humidity,
temperature and pressure, is more likely to be a ected by a ‘drift’ in accuracy. Uncategorized
In situations where the quality of the measurements is imperative for maintaining quality, you need to
ensure that the instrument is operating within an acceptable range of error, and calibration is essential for validation master planni
this.
Validation Services
In order to ensure that you can enjoy complete con dence in the measurements and the output of any piece
of equipment, calibration of instruments needs to be performed on a periodic basis.

What is Equipment/Instrument Calibration & What Does It Do? Recent Posts

Instrument calibration is amongst the primary (and often the most crucial) methods of checking Understanding Instrume
and maintaining the quality of measurements made by instruments. The measurements are Calibration Documentat
checked and compared, and the instrument is con gured to provide results which are within an
Found vs. As Left
acceptable accuracy, precision, and repeatability range.
January 15, 2018
Minimizing, or altogether eliminating, factors that could cause inconsistencies and errors are a 5 Bene ts Accredited La
fundamental part of instrument design philosophy. There are various service providers you could Calibration Services Brin
turn to for your instrument calibration requirements. These often o er specialized services like Business
laboratory calibration services or pipette calibration services, which are customized to the needs
January 8, 2018
and requirements of various industries.
The Signi cance of Calib
Though the exact method used for calibration of equipment depends on the instrument in
Hazardous Areas
question, the procedure typically involves most or all of the following steps:
December 11, 2017
One or more test samples or standards with known values, often called ‘calibrators’, are measured using the
test instrument. 8 Important Things to Lo
The results obtained are compared with the actual values, thus establishing a relationship between known When Buying Pre-Owned
values and the measurement technique. Equipment
Using this process, the instrument is, in essence, ‘taught’ to produce more accurate results than it would December 4, 2017
otherwise.
Post calibration, the instrument can measure unknown samples with higher reliability of precision and
5 Tips to Help You Prepa
accuracy. FDA Inspection
November 20, 2017
Using known standards of di erent values, multiple calibrations are performed to establish a
better correlation at di erent stages within the entire operating range of the instrument. While
you might want to perform calibrations at many di erent points to plot an accuracy curve, this
may not always be the best choice, since:

Costs associated with labor and time can rack up quickly, so you need to limit the number of calibration
points accordingly.
The relation between number of calibration points and the resulting performance might not be linear.
Practically speaking, you’ll need to make tradeo s between the e ort and cost of calibrations, and the
desired performance levels.

Instruments tend to perform best when they’ve been calibrated according to the
recommendations of the manufacturer. The performance speci cations include intermediate
points, which are used for calibrations. The process speci ed is designed to ‘zero-out’, i.e. basically
eliminate, the inherent errors in the instrument at those points.

What Factors A ect Calibration?

Once you’ve understood the bene ts of performing calibration and how critical it can be for
maintaining quality, it’s quite apparent that it should be dealt with carefully. While designing the
calibration procedures and during the actual calibration, some steps must be taken to eliminate
potential error sources that can degrade the quality of the results.

For extremely sensitive instruments, you may need to take them to a calibration laboratory or
other calibration service provider, where they can be calibrated under controlled conditions.
There are a number of factors that can a ect calibration results otherwise, both during the
calibration procedure and afterwards.

These include:
Using the Wrong Values

The instructions for calibration need to be followed very closely. The calibrator mentioned in the instructions
is the one that the instrument will ‘learn’ from. Disregarding the documentation and choosing a di erent one
or the wrong values changes the way the test instrument behaves. This can produce signi cant errors within
some parts or the entire operating range of the instrument.Some of the newer instruments have a built-in
software diagnostic system that can alert operators when the order in which calibrators are tested is wrong
(Calibrator-B used before Calibrator-A). However, they may not be able to distinguish between calibrators
that use the wrong values.
Calibrator Formulation Tolerance

Just like your equipment, the quality of the calibrator you use can a ect the results of the calibration. Using
calibrators manufactured by reputable and trustworthy manufacturers or calibration labs, which are built to
precise speci cations and tolerances, is essential for obtaining repeatable performance and dependable
results. There is another tolerance that is associated with the design and formulation of a control or
calibrator. This is due to normal inaccuracies and variations in quality control processes and the instrument
itself.For example, if you’re using calibrators whose nominal values are 50 and 800 mOsm/kg (H2O), and if
they’re both manufactured to perform at the lower end of the required range, the net e ect of calibration
may be to lower the accuracy or precision. This would result in additional errors in the range of several
mOsm/kg, over the entire range the calibration was performed on.
Here’s why:
The calibration process will ‘teach’ the instrument to read 800 incorrectly as 796, so the actual results curve
will be higher than if the instrument was calibrated as per the correct value of 796, or if the calibrator was at
the actual required formulation of 800 mOsm/kg.
If it is assumed that one calibrator is at its nominal value (800 mOsm/kg), but the true value is o by just a
tiny bit, say at about 796 mOsm/kg, the resulting curve is well o the assumed result.
Ideally, the resultant calibration curve should be linear, but even small errors can have a drastic e ect.
If the instrument is calibrated in this situation, any measurements made with it will be inaccurate, until it has
been recalibrated with the correct values.
Sample Preparation TechniqueAs with normal testing, you should always use good techniques for sample
preparation. This is essential for optimizing the resultant performance through calibration. A similar situation
to the one discussed above can result if the sample itself has not been prepared properly for the calibration.

Good sample preparation techniques can help eliminate a number of sources of possible
inaccuracies and contamination in the sample; some of which include:

Pipetting di erent volumes of the sample.

The presence of air bubbles in the sample.
Inconsistencies resulting from evaporation (which is caused by preparing samples too early).

All of these situations can cause more variations in the results obtained from the equipment
calibration process. The increase in number and scale of the variations can cause the mean values
obtained through calibration to vary signi cantly. The result would be that the calibration curve
would erroneously shift and the errors in all the results would increase.

Ambient Temperature E ects

Even when you perform calibration of instruments using the correct values, reliable calibrators with the
correct tolerance and the correct sample preparation technique, errors can still result from other factors.
Environmental factors, like the temperature of the surroundings, can have a huge impact on the results of
the calibration:
Instruments should be calibrated in an environment where factors that can a ect the performance, like
temperature, pressure and humidity, are closest to those of the surroundings it is operated in.
Variations and di erences in operating temperature can a ect the performance of electrical and other
components.
Instruments calibrated at one particular temperature, or in uctuating temperatures may be prone to
temperature-induced errors if it is operated in a signi cantly di erent environment. This can degrade the
accuracy of the calibration results.

How Frequently Should An Instrument

Be Calibrated?
There’s rarely a set ‘perfect’ calibration frequency for any instrument, since there are a number of
factors that need to be taken into account while designing a calibration regimen. This means that
the correct frequency can often only be described as – “as and when it’s needed”.

You can create a history for di erent instruments by tracking the changes in measurements of a
known value and by comparing the “as-found” and “as-left” results of each calibration.

Of all the things you should consider, the most weightage will probably be given to just how much of an
e ect the instrument in question has on the overall quality.
A close second would be the manufacturer’s recommendations and the instrument’s tendency to ‘drift’ out of
calibration.
Recalibration may be warranted after any events that could throw the precision or accuracy. Such as an
electrical fault, a fall, or other impacts.
Another time when you may need to perform an unscheduled calibration is just before a particularly
important measurement is made.
Calibrating an instrument each time you plan to use it, just to check its performance isn’t always practical and
it can get very expensive, very quickly.
Control solutions with known values can be tested every day or periodically, which can provide an indication
of the performance and establish a history.
If the results from the control data do not indicate any issues or inaccuracies in the instrument’s
performance, then you can continue using it till the next scheduled calibration.

Slight variations between measurements are to be expected, and will occur despite your best
precautions. As long as they fall within the limits of the acceptable range for errors, there’s no
reason to perform an unscheduled re-calibration.
However, if it looks like the measurements are close to the limits of, or beyond the acceptable
performance criteria, it might be a good idea to calibrate it. This is also true of signi cant short-
term shifts (like while operating the instrument in di erent environmental conditions).

When you’re designing a calibration routine, it’s extremely important to take into account any
regulations governing your eld of operations. Check the requirements of quality compliance
organizations, as well as speci c standard operating procedures for laboratories and government
regulatory authorities.

These may require instruments to be re-calibrated even if there’s no evidence that it is needed.
The requirements should be followed nonetheless and should always be given precedence over
all else. Any issued guidelines can be used at times, especially if you’re unsure about whether an
instrument needs to be calibrated to improve accuracy.

 September 15th, 2015  RS Calibration

 Calibration, Calibration Services

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