Regulatory compliance is the force that drives calibration within the pharmaceutical and medical device industries. This comes as no surprise, after all, the failure of an instrument to control or monitor critical process parameters within specific limits for accuracy and precision could have an adverse effect on the health of hundreds, maybe even thousands of people. Most companies understand the fundamental significance calibration, so much so, this has led to a circumspect approach to the management of calibration programs. The problem with a cautious approach is, yes, the approach may ensure compliance, but at what cost to the overall business?
Most often, the over cautious approach comes from the failure of a calibration program to optimise as the plant moves from the project phase, well into the operational phase. In the project phase, theoretical design values are confirmed in the real world, and the plant moves into production. It is in the project phase that the calibration program is first initiated. Calibration specifications such as the calibration ranges, tolerances and intervals are specified. At this stage, historical process and instrument performance data is non-existent so a cautious approach is appropriate. What companies fail to do, is to optimise when data becomes available, as the plant and calibration program matures. An effective calibration program should be proactive not reactive.
A probe used to monitor the temperature in a water bath was originally assigned a calibration range equal to the operating range specified by the manufacturer. The manufacturer operating range of the probe is -20 to 400 °C. The probe is calibrated at various points going from -20 to 400 °C. Initially, there was no problem, all calibration results were in tolerance. But after a period of time, the instrument started to fail at calibration points in the range 380 to 400 °C. The probe was a critical instrument so corrective and preventative action was initiated to deal with the non-conformance. Upon a lengthy, time consuming review, it was determined that the actual range the process required the probe to operate in was 80 to 100 °C. The instrument calibration results in this range were all in tolerance.
Whilst the outcome from the reactiveaction was satisfactory with regard to patient safety, the cost to the overall business was significant. People and time were needed to investigate the non-conformance, people and time cost money. Yes, patient safety is paramount, but the same result could have been achieved with proactiveaction in the form of calibration optimization.
In the current highly competitive global market, over calibration of a company’s assets is no longer acceptable. The need for leaner, more efficient and FDA/EudraLex/ISO compliant calibration programs is ubiquitous in modern pharmaceutical and medical device facilities. The answer, bespoke solutions that are powered by experience. The Lotusworks Calibration Optimization Program (COP) is an example of an approach to calibration management that has been proven to add significant value to our client’s overall business activities. Science and risk management are the key to its success.
The program provides a bespoke solution to instrument classification and interval determination that can reduce the number of yearly calibrations using proven scientific methods. Instruments are classified according to their criticality. By focusing on criticality, valuable resources are focused on the instruments most critical to the manufacturing process. A statistical algorithm is utilised to derive appropriate calibration intervals. The derived intervals have sound scientific justification, ensuring intervals are based on actual performance and environmental conditions each individual instrument experiences. Optimization of the calibration program will lead to an increase in equipment availability. Asset management is of high importance and when carried out correctly, the effects can be multifaceted.
It is counterintuitive to think that a reduction in cost could be accompanied by a reduction in risk to product quality, patient/operator safety and the environment, but in fact, the optimisation of a sites calibration program using the Lotusworks COP ensures this comes to fruition.