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In today's industry, sustainability and resource conservation are becoming increasingly important, especially in the pharmaceutical sector. Rising costs for electricity and heat are increasing operating expenses, forcing companies to rethink their supply strategies. In Switzerland, efficiency in energy use plays a central role in the federal government's Energy Strategy 2050. In 2018, the chemical and pharmaceutical industry accounted for around 27% of total consumption in the industrial sector. Cleanrooms and other GMP facilities have a significantly higher demand than typical office buildings, as they require large quantities of conditioned air. According to the DIN EN ISO 14644-16:2020 standard, consumption in these areas is around ten times higher than that of offices. In view of this high demand, regular operational optimization is strongly recommended for both new and existing systems.
In the case of newly constructed systems, it is often assumed that no adjustments are necessary. Nevertheless, it is advisable to consider increasing the efficiency of these facilities as well. Possible reasons for this are undetected defects that can be uncovered in this way, as well as systems that may not have been adjusted or calibrated to their final process type. In addition, there are facilities that initially only run in partial operation or those that have not been calibrated in partial or full load mode.
A mix of three strategies is often pursued to improve energy efficiency and decarbonization: Sufficiency (reduction), efficiency (optimization) and consistency (produce differently). However, the Swiss Federal Office of Energy emphasizes the priority of sufficiency: "The cheapest and most environmentally friendly energy is that which we do not consume and therefore do not have to produce in the first place." Measures should therefore be implemented in the following order: first sufficiency, then efficiency and finally consistency.
A methodical approach is crucial for the success of operational optimization. First, the current status is recorded and analyzed in order to create a basis for deriving improvements. These approaches must be evaluated in accordance with the requirements and specifications. Success is only assured once the results have been verified by a final check.
Optimizing operations in a GMP environment brings with it special challenges. These include internal company specifications, existing usage requirements, safety aspects, product protection, operational safety and various GMP guidelines (such as Annex, Pharmacopoeia, ISO 14644). The different needs of various stakeholders must also be taken into account. However, holistic planning is often neglected. An interdisciplinary approach is therefore essential for successful adaptation, in which all stakeholders are involved at an early stage in order to incorporate their respective needs. These factors have a significant influence on demand and should be thoroughly examined, as they strongly influence the potential for reducing consumption (sufficiency).
Existing energy and performance data should be used for the analysis. If this is not sufficient, provisional measurements or calculations based on assumptions can be carried out. Energy management or energy monitoring is generally recommended for complex systems. A retrofitted management system not only makes it easier to identify savings and efficiency potential, but also strengthens security of supply through its control function and enables potential faults to be detected more quickly.
Optimization measures can be derived from the evaluation of the key figures determined and the understanding of the system functions. These are to be assessed according to criteria that are defined in consultation with the client. In addition to the requirements and specifications, institutional risks must also be identified and evaluated. In addition to the reduction in consumption, safety and other important criteria, the investment costs, possible downtimes and operating cost savings of the interventions must also be determined and evaluated.
Implementation requires careful planning. Once approved, every initiative must be documented in detail, starting with a change request and, if necessary, additionally checked by means of a risk analysis. Plant and system downtime costs time and therefore money. Production interruptions should therefore be kept to a minimum, ideally by carrying them out during regular maintenance periods. A sufficiently large and realistic time window should also be planned, and a plan B should be provided for critical activities.
A performance review after implementation of the interventions is essential in order to successfully complete the efficiency improvement. Measuring instruments and records are necessary for evaluation and verification. As operational optimization is a continuous process, implemented steps should be regularly checked and secured. Readjustments are often necessary in order to achieve the maximum benefit.
If you are facing similar challenges in your GMP production, let's talk. We at pixon engineering AG look forward to supporting you in increasing the efficiency of your processes!
Insights from Thomas Heinzmann, Senior Project Engineer Mechanics and Team Leader at pixon.
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