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