Process engineering (PE)

Kilolab scale-up:

• Scaling up reactors, pumps, and other processing equipment. 
  Scaling up reactors, pumps, and other critical processing equipment is a critical task that our qualified process engineers take on. This vital responsibility involves selecting larger equipment with careful consideration so that it can handle higher volumes and maintain the integrity of chemical processes. We take extra precautions to adjust process parameters as needed to guarantee that the performance of upgraded equipment corresponds to that of its laboratory equivalents. Development:
  
  
• Transfer of process from the laboratory to manufacturing.
  Our skilled process engineers at Porton oversee the smooth transition of lab procedures into production environments. They meticulously upgrade processes, record protocols, educate staff, and maximise equipment for seamless integration. They maintain the effectiveness and quality of the product throughout the scaling process by carefully monitoring the first production runs and optimising the settings.
  
  
• Planning and overseeing pilot plant trials to validate the scaled-up process (while identifying and addressing possible issues at larger scale).
  Pilot plant experiments are something we're actively doing, under the direction of our committed process engineers. These tests are an essential part of verifying that our lab-developed procedures are scalable. We keep a close eye on a number of factors, such as system stability, product quality, and performance. By taking a hands-on approach, we can refine our processes prior to going into full production. We guarantee the integrity and safety of our production processes as we grow to higher sizes by putting these safeguards in place.
  
  
• Ensuring compliance with regulatory requirements for larger-scale manufacturing.
  One of the primary responsibilities of process engineers is to guarantee compliance to regulatory requirements. Production scaling increases the complexity and importance of compliance. We modify procedures to satisfy legal requirements for quality, safety, and environmental effect. They collaborate closely with regulatory affairs and keep up with all pertinent rules to guarantee that all production processes are compliant. To support regulatory inspections and approvals, rigorous maintenance is applied to documentation and audit trails.
  
  
• Preparing documentation for regulatory submissions. 
  Our engineers ensure that all documentation is transparent, precise and complies with regulatory requirements. In order to receive approval to launch new or enlarged items, this documentation is essential. To obtain regulatory approval, comprehensive documentation and effective communication are crucial.
  
  
• Assessing the environmental impact of larger-scale operations and implementing measures for sustainability.
  It is crucial to evaluate and manage the environmental impact of scaled-up activities, with an emphasis on lowering waste, emissions, and energy use. The goal of engineering is to increase resource efficiency and provide more ecologically friendly solutions. Making data-driven judgements is aided by ongoing environmental performance monitoring in enhancing sustainability. The initiative promotes corporate social responsibility goals and worldwide environmental standards in addition to supporting regulatory compliance.
  
  
• Conducting cost analyses for the scaled-up process and identifying opportunities for cost savings.
  To identify areas for cost savings in scaled-up processes, process engineers perform in-depth cost studies. They examine every step in the production process to identify areas where costs might be cut without compromising effectiveness or quality. Renegotiating supplier contracts, increasing operational efficiencies, and optimising the use of raw materials are some examples of strategies. Engineers contribute to ensuring the product's economic sustainability in competitive markets by skillfully managing expenses.

Calorimetry study:

• Selection of reactions or process steps to assess (e.g., synthesis reaction, quench reaction, distillation residue, wet cake, reaction mixture at hold points, etc.) 
  Making this choice is essential to understanding the thermal characteristics of different phases, including wet cakes, reaction mixtures at hold points, distillation residues, synthesis reactions, and quench reactions. Engineers seek to identify any thermal threats and guarantee process safety by concentrating on these crucial areas. Usually, the phases that are chosen are those that are crucial to the quality of the product or have a higher risk of exothermic reactions. This calculated decision aids in maximising process efficiency and safety overall.It is a common practice to test the same starting material produced by different manufacturers. As a result of different production processes from different manufacturers, the same starting material often has different properties (overall purity, type of impurities particle size, etc.) which can significantly impact the quality of the produced intermediates and final product. Use tests are therefore essential for selecting the appropriate manufacturer and specifying (both qualitatively and quantitatively) the Critical Mass Attributes of starting materials to obtain the final product within set specifications.
  
  
• Selection of calorimetric instrument based on the nature of the study (isothermal, adiabatic, reaction calorimeter). 
  We have three options for calorimeters: reaction, adiabatic, and isothermal, depending on the particular requirements of the investigation. varied types of instruments offer varied insights into the process's thermal behaviour. For example, reaction calorimeters are used for dynamic measurements, adiabatic calorimeters are used to determine the maximum temperature under loss of control, and isothermal calorimeters are used for studies at constant temperature. This meticulous selection guarantees accurate and pertinent data collection, enabling efficient process management and safety assessments. 
  
  
• Selection of homogeneous and representative samples of the reaction or process step. 
  It is necessary to choose homogeneous and representative samples of the reaction or process phase for calorimetric analysis. To enhance process scale-up, samples must be carefully prepared to guarantee consistency and reproducibility of results. In order to accurately determine thermal characteristics and guarantee that the studies conducted are trustworthy and appropriately represent manufacturing settings, this step is crucial. 
  
  
• Calculation of heat of reaction, deterioration temperature, time to maximum rate of reaction, and other thermodynamic parameters of interest. 
  Calculating several thermodynamic parameters, such as the heat of reaction, the quenching temperature, and the time to maximal reaction rate, is one of the primary duties. Understanding the energy shifts that occur in chemical reactions and evaluating the possible hazards to safety depend on these computations. This in-depth analysis aids in the development of reliable production processes by predicting how chemical reactions would behave under various circumstances. 
  
  
• Comprehensive safety assessments for smaller and larger-scale operations. 
  Process engineers at Porton are tasked with performing thorough safety evaluations. The evaluation of the thermal and chemical risks connected to both small-scale laboratory research and larger-scale industrial operations is part of these assessments. Engineers can put in place necessary safety measures, including cooling systems or pressure release devices, by being aware of these concerns. In the end, this proactive approach to safety protects people and the environment while preserving product integrity throughout the manufacturing cycle. It also helps prevent accidents and guarantees adherence to industry laws.

QBD:

• Process modelling (distillation, crystallization, filtration, extraction, mixing modelling, etc…) 
  For Porton's engineers, process modelling is a fundamental role within the framework of Quality by Design (QbD). To mimic and improve procedures including distillation, crystallisation, filtering, extraction, and mixing, they employ modelling approaches. This improves their comprehension and control over the production by enabling them to forecast how these processes would behave under different circumstances. The efficiency of their processes and the quality of their output can be greatly increased by using sophisticated software and analytical tools. This proactive strategy guarantees strong process design from the beginning and reduces risks related to scale-up. 
  
  
• Identification of critical material attributes and process parameters and defining the allowed ranges 
  As part of the QbD framework, process engineers are essential in determining Critical Material Attributes (CMA) and Critical Process Parameters (CPP). This entails a careful examination of how process variables and material attributes affect the end product's quality. Through the identification and comprehension of these crucial elements, engineers develop control zones that guarantee constant product quality. To maintain compliance with strict regulatory standards and to guide manufacturing, permissible limits are rigorously documented. Production process optimisation and improved product reliability are made possible by the methodical identification and management of CMAs and CPPs. 
  
  
• Lifecycle management (continuous method monitoring) 
  Throughout the duration of the product, this includes continuous method and process monitoring and updating in response to new knowledge and technological advancements. Through continuous evaluation of process performance and product quality, engineers may make necessary adjustments and effectively handle any new problems that may arise. This continuous optimisation process shows a dedication to upholding high standards and making adjustments for modifications in production needs or legal requirements. In order to sustain product effectiveness and security, such thorough lifecycle management is necessary, which supports Porton's goal of providing high-quality products.