The Role of Calibration in Ensuring Safe Measuring Instruments for API Manufacturing

So far, we’ve addressed contaminant-free equipment and cleanrooms. Today, we’re tackling critical measuring instruments.

Posted: January 8, 2016

API Manufacturing and Pharmaceutical Manufacturing

It’s not enough that equipment is contaminant free. Critical measuring instruments (i.e. pressure devices, temperature devices, pH, scales, etc.) must also perform correctly. 

Measuring devices are critical to ensure safe operations, as well as manufacturing that yields quality products. Without calibration, the level of uncertainty increases. Depending on the type, this uncertainty may lead to a potential failure of equipment, of product, of environmental controls, and of preservation of human life. This risk is minimized by having backup measurement equipment, either online or on standby.

Because of the potential risks, routine, regular calibrations are a critical aspect of manufacturing at PCI Synthesis.  We have defined critical parameters that require fully functional instruments.  Calibration verifies that these instruments are fully functional.

So how exactly is calibration performed in a manufacturing organization, such as PCI Synthesis?  It is performed  using standards, which consist of a known measurement (i.e., 20.0 kg test weight, temperature calibrator set a 140 °C, pH 4.0 buffer solution, etc.).  Then the instrument in question must correctly measure the standard input.  Calibration usually involves a range of different standard measurements to ensure that the instrument functions in the designed operating range.

If the instrument passes, then it is returned back into service.  If an instrument fails to record the proper measurement, an adjustment is usually made to the instrument.  After the adjustment is made, the calibration sequence is repeated.  If it still fails after the adjustment, then it is removed from service and replaced with an equal or similar model.  Additionally, an investigation is usually conducted to determine the impact of the failed device on the quality of the manufactured product.

Proper calibration of measuring instruments represents one of the ways that PCI Synthesis ensures safe operations, a sound manufacturing environment and quality products.   While it may seem like a minor process its potential to deter risk can be huge. 

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Should you Use an Overseas Partner When Manufacturing Controlled Substances?
New Automated Purification Strategies for Scale-Up
Top Analytical Method Validation Mistakes and How to Avoid Them – Part 2

About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.