Calibration
Avoiding compliance and safety issues in fine chemicals
By Monica Kruger, Beamex S
afety and compliance are non- negotiable in the fine chemicals industry, which produces complex, pure chemical substances such as active pharmaceutical ingredients. Fine
chemicals are batch driven, with complicated, multi-stage processes where accuracy and efficiency are critical. In this industry, one of the keys to ensuring
both safety and compliance is that measurements taken throughout the production process are accurate, which can be challenging with paper-based calibration. Paper-based calibration is time consuming and because it relies on manual data entry, prone to errors. It is commonly accepted that the typical
error rate in manual data entry is about one per cent, which, while it might not sound like a lot can have huge implications for your calibration process. How can automated calibration help to address these challenges?
a paperleSS proceSS to the reScue Automated calibration solutions combine software, hardware, and calibration expertise to deliver an automated, paperless flow of calibration data with minimal need for manual data entry. This not only saves time and makes the process far more efficient, but it also helps to avoid mistakes typically associated with manual data entry - thus improving the quality and integrity of the calibration data. Furthermore, calibration results are safely
stored, tamper proof, and easily accessible in the calibration software for review, for example for audit or analysis purposes.
Safety, coMpliance, and continuouS iMproveMent Removing human error reduces the chance that a production batch will be rejected due to out-of-tolerance calibrators and helps to ensure compliance with regulations like GMP and 21 CFR part 11. Automating calibration processes also brings
significant financial benefits. For example, if an instrument is found to be out of tolerance, at minimum it requires that the product is quarantined and subject to risk analysis and investigation. In the worst case, the entire batch will have to be discarded, increasing waste and leading to large financial losses. Furthermore, with calibration data in digital
form rather than sitting in siloed paper archives it can be integrated with ERP systems, helping management to understand what is going on and supporting better decision-making. And with everything in one easily accessible system, data across factories can be easily compared to spot trends and identify areas for improvement. It is important to remember that any
automated calibration solution should be based on a thorough analysis of your specific needs to ensure the process is well designed and error- free. This is where working with a trusted advisor who can help analyse the process and find areas for improvement really pays off. Read more about the benefits of
automated calibration for the fine chemicals industry:
https://resources.beamex.com/lp- improve-safety-and-ensure-compliance-in-the -fine-chemicals-industry
Beamex
www.beamex.com
Instrumentation Monthly March 2022
45
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