Feature sponsored by Calibration P
atient safety and ensuring compliance with regulations – including FDA Current Good Manufacturing Practice (CGMP) and 21 CFR part 11 – are the top priorities in the pharmaceutical industry. The
industry is also facing a range of other issues, including the need to ensure data integrity, improve business efficiency, and enhance sustainability. “Pharmaceutical companies are increasingly turning towards digitalisation solutions to deal with a whole host of critical challenges,” says Sami Koskinen, director, Digital Transformation at Beamex.
A FOCUS ON SAFETY In pharmaceutical manufacturing it is essential that strict safety guidelines and regulations are followed and that manufacturing processes are consistent and reliable. This safeguards product purity and ensures the highest possible end-product quality, which is vital to protecting patient safety. Properly maintained and calibrated equipment is also important for ensuring employee safety at production facilities - ensuring properly calibrated pressure sensors on reactors, for example. Digital calibration makes it easy to check equipment is within tolerances and track performance over time, enabling targeted maintenance when needed.
THE NEED FOR COMPLIANCE Compliance with regulations is key to the safe and efficient production of pharmaceuticals. In addition to safety, there is a compelling business reason to ensure compliance as a production facility can be shut down for being
non-compliant. A large production facility has thousands of instruments potentially undergoing hundreds of thousands of calibrations per year. When this process uses paper calibration certificates, it not only creates a mountain of paperwork - it also means that the risk of human error is always present. Paper also makes audits time consuming and complex. Digitalising the
whole process eliminates the possibility for human error and makes audits easier.
IMPROVED DATA INTEGRITY Data integrity, the assurance of data accuracy over its lifecycle, is extremely important for both patient safety and compliance, and paper-based systems often fall short in this regard. Paper gets lost or data can be mistyped when entered manually into digital systems. For this reason, whenever there is a step that requires manual data entry, the “four eyes” principle is in use, where a second person checks that data input has been performed correctly. This of course requires more resources and thus reduces efficiency. Digitalisation and smart calibrators ensure that results are sent automatically to a centralised system, removing the need for manual data input and an extra pair of eyes.
INCREASED BUSINESS EFFICIENCY Currently, a large amount of useful data is locked up in a difficult-to-use and fragmented format: paper certificates in binders. When digitalised, this data becomes easily searchable and can be analysed to track trends and identify areas for improvement. For example, with digitalised data stored in a central repository, performance comparisons between shifts or across different production facilities can be used to establish benchmarks and focus improvement efforts.
BETTER SUSTAINABILITY There is a growing trend towards sustainable business practices, and the pharmaceutical industry is no exception. To take just one
54 September 2022 Instrumentation Monthly
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