Cleanroom calibration (designed by Tim Sandle)
Pharmaceutical testing is a critical quality
control step that ensures the produced products can withstand specific
activities and will perform as patients expect. Friability testing examines
tablets’ strength, verifying that they will not break or crumble during
transport or handling. Drug assays reveal whether the strength of active
ingredients in a tested sample matches its label. Performing these tests and
others on the required schedules allows pharmaceutical manufacturers to operate
within regulatory requirements.
By Emily Newton
However, the testing equipment must be
properly calibrated and maintained for reliable results. Maintenance and
calibration-related shortcomings can have far-reaching effects that disrupt
operations and cause the affected companies to receive unwanted scrutiny.
Calibration and Maintenance Flagged by Inspectors
Pharmaceutical companies are in a tightly
regulated industry, which means periodic checks occur to confirm that the
entities follow all required procedures. When inspectors visited the New Jersey
site of an American multinational pharmaceutical company, they found eight problems, including some
related to the calibration and maintenance of equipment.
More specifically, the inspection report
showed some of the plant staff who tested its products did not have adequate
training. Since knowing how to perform a test means understanding when and how
to calibrate the associated equipment, the lack of role-related education could
have serious consequences. Additionally, inspectors discovered stability
samples were missing for some drugs, suggesting workers did not perform them on
the appropriate schedule.
Another testing-related issue was that
problems associated with the company’s electronic data-tracking system left
test information open to tampering. In any case, when maintenance and
calibration do not happen as required, people cannot trust that the results are
accurate.
Inspectors want to see that the parties
handling the calibration, testing and recording of the outcomes have the proper
training and that all steps have occurred consistently and at the right times.
Otherwise, all the results could become untrustworthy, making it impossible to
ensure the safety of those taking the affected drugs.
Sensors Installed to Maintain Consistency
Pharmaceutical companies often rely on sensors
to maintain consistent conditions in demanding environments. The sensor data
can also alert workers to an abnormality that could render test results
inaccurate. For example, nitrogen is a carrier gas used with some
chromatography testing equipment. The pharmaceutical industry typically uses a type with a 99.99% gas concentration, marketed
as ultra-high-purity nitrogen. If the gas is less pure for any reason, an alert
is necessary.
Pharmaceutical tests need specific
environments and correctly calibrated, well-maintained equipment to achieve
accurate results. Fortunately, connected sensors can generate notifications
when they encounter unusual conditions or reminders for maintenance. Some
sensor equipment also connects to recordkeeping platforms, registering when
individuals perform particular steps.
Even highly observant pharmaceutical factory
workers cannot manually check all environmental parameters. However, sensors
can work in the background and alert staff when readings fall outside of preset
parameters.
Similarly, sensors can verify when machines
are correctly calibrated, eliminating or reducing many of the manual checks.
Even the most observant workers sometimes get tired or become distracted.
Strategically deployed sensors increase awareness, so poor calibration or
inadequate maintenance cannot disrupt the production environment. Some
pharmaceutical executives already use sensors for supply chain monitoring. This
decision can halve associated costs, making it worth
pursuing.
Automation Used to Reduce Manual Work
Many pharmaceutical decision-makers have
realized automated technologies are essential for helping calibration and
testing go more smoothly and efficiently. One reason automation is so
beneficial is because it boosts productivity by handling many of the steps
workers formerly did manually. Additionally, automated sensors with predictive
algorithms measure machine operations in real time, detecting abnormal
vibrations, temperatures out of an acceptable range or other unusual details.
Some businesses also use robots to test
injectable drugs, such as verifying the volume of the delivered medicine or the
force a patient must apply to remove the injector’s safety cap. Since robots
excel at repetitive tasks, they are ideal for these quality control
verifications. Also, people who formerly oversaw manual tests can reskill to
set up and supervise the automated testing equipment. Then, there is a reduced
likelihood of testing mistakes that degrade accuracy.
Moreover, sensors that automate calibration
give people more confidence in their results. One example measures pH and
automatically performs a standard calibration before transferring
all the associated data to the process control system. That approach creates a
reliable audit trail and shows that the pharmaceutical company has prioritized
recordkeeping. Additionally, when calibration requires adjusting the machine,
the necessary steps always occur in the same sequence.
Leaders in other industries — such as oil and
gas — have used robots to check equipment and take readings for validation.
Applying that option to pharmaceutical facilities could save time while
ensuring accuracy because there is a lower chance of humans accidentally
contaminating the environment when they take measurements by hand.
Accuracy Solidifies Trust
The pharmaceutical industry is highly
competitive and tightly regulated. Patients, those who prescribe medications
and other stakeholders must trust that the products made within this sector are
safe and effective. Well-maintained, carefully calibrated testing equipment
fits leaders’ quality control goals while bolstering brand reputation and
loyalty.
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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