22 JULY 2016 | PHARMACEUTICAL PROCESSING
Life sciences companies must perform regular calibrations of
instrumentation to meet regulations, but these can be costly.
Modern instrumentation simplifies the process
By Ravi Shankar, Life Sciences Industry Manager, Endress+Hauser
To fulfill regulatory compliance and ensure quality, life science companies must perform traceable calibrations on instruments. But calibrations are costly, time-consuming, can
cause process downtime, and pose an increased
risk for contamination. Many instruments on the
market today provide self-diagnostics features
which give users information about the health of
ISO9001:2008-7.6, GMP, and WHO regulations
and standards all require equipment and
instrumentation to be calibrated or verified at
specific intervals against measurement standards
traceable to international or national standards.
However, it is always the plant operator’s
responsibility to define and execute a proper
The task is finding the right balance between
saving operational cost by extending intervals while
ensuring quality and reliability. The main issue
with extended calibration cycles is the performance
of instruments between calibrations.
The first recalibration step after an instrument
has been installed and working for a period of time
is to determine if the instrument is still operating
within specifications. A failed “as-found” check can
be critical and has to be further investigated for
possible impact on product quality. A substantial
number of FDA warning letters are issued because
remedial action has been considered insufficient.
Calibrations are expensive but provide very clear
results for the user. Even though many instruments
have proven exceptional long-
term stability, which exceeds
the entire lifetime of the
equipment, they still have to be
checked regularly to avoid legal
implications and possible issues.
Some companies calibrate every
six months (Figure 1).
The criticality of the process
parameter helps define the
maximum acceptable risk
level. The blue line in Figure
1 shows how an instrument
can deviate over time, but it
is recalibrated back to initial
specifications every six months.
The average deviation (risk)
between calibrations must always