Balance Calibration in the Pharmaceutical Industry

Balance Calibration in the Pharmaceutical Industry

Calibration of a balance can be performed in two ways, either using internal or external calibration weights. Internal weights It is common for electronic balances to have one or more internal calibration weights installed into their systems. Calibration using internal weights can be performed when selected by the user, when a specified temperature change occurs, or following a specified elapsed time period. Internal calibration adjusts the balance back to its zero point, adjusts the maximum load of the balance, and in the cases where two weights are used it will also adjust the midpoint of the balance linearity. Often, balances with internal calibration weights will also run performance checks, allowing the user to check things like the difference between the measured and recorded mass of the calibration weights. External weights External weights used for calibration must meet specifications outlined by the International Organization of Legal Metrology (OIML). There are parameters set regarding suitable materials of construction, the shape and permitted tolerances of external weights. There are also guidelines regarding the information on weight classes with means of adjusting the weights during recertification. External calibration methods must satisfy the boundaries outlined by the OIML. External weights must be constructed of austenitic (non-magnetic) stainless steel, manufactured with a hollow center where small stainless steel ball bearings can be added or removed to return the weight to tolerance. These weights themselves must be recalibrated at least every two years to ensure their accuracy. Why is calibration often outsourced? In the pharmaceutical industry, the calibration of balances is often outsourced, and the option is becoming more popular over time. Biopharmaceutical manufacturing often emphasizes the speed at which it can get products out of the research and design phase to being commercially available. This is the major driver for outsourcing calibration, because it is often a faster method than having research teams do it in-house. There is a trend in the industry to only focus on conducting those processes that add the most value, anything else is being outsourced rather than using internal resources. This has led many pharmaceutical laborites to reassess their calibration practices and outsource them to calibration service laboratories. The past two decades have seen a steady rise in this trend, and out of this highly specialized companies have grown, offering reliable and cost-effective qualification, validation & calibration services. It is ushering in a shift in standard laboratory practice in the pharmaceutical industry. Sources: Benvenuti, M. (2019). Validation, Qualification and Calibration in a Pharmaceutical Facility. [online] Sgs.com. Available at: https://www.sgs.com/en/news/2014/02/validation-qualification-and-calibration-in-a-pharmaceutical-facility [Accessed 12 Nov. 2019]. Erickson, J. (2019). [online] Files.alfresco.mjh.group. Available at: http://files.alfresco.mjh.group/alfresco_images/pharma//2014/08/22/238325c1-8373-4382-b758-374255558829/article-10565.pdf [Accessed 12 Nov. 2019]. Resource.npl.co.uk. (2019). [online] Available at: http://resource.npl.co.uk/docs/science_technology/mass_force_pressure/clubs_groups/instmc_weighing_panel/pharmaweigh.pdf [Accessed 12 Nov. 2019]. Further Reading



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