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.
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Pharmaceutical Microbiology Resources