The framework conditions in the highly regulated life sciences industries are changing rapidly. The demands placed by authorities, doctors and consumers on the safety of medicines, synthetically or biotechnologically produced active substances and their production processes, as well as on medical technology implants and modern diagnostic kits, are constantly increasing. At the same time, the price pressure on manufacturers is becoming ever more noticeable.
As a result of this development, integrated and effective factory planning is now more than ever a prerequisite for the growing industry in the highly regulated market in order to react flexibly to changes and produce efficiently.
Chemgineering supports you in planning your GMP-compliant factory. To this end, all requirements for laboratories, production areas, critical auxiliary systems, warehouses and infrastructure facilities are analyzed and documented in well thought-out steps. With an interdisciplinary team, we develop different variants and evaluate them with the simulation of your production process.
The use of research, development and production facilities by the regulated industry is subject to rapid change. This is because the framework conditions for the pharmaceutical industry and related sectors are changing rapidly. Mergers & acquisitions play just as much a role as technological innovation and ever-increasing market requirements.
The GxP and regulatory requirements are changing the landscape of the industry concerned - in a similar way to the stricter environmental protection laws. Improved global market opportunities and lower trade barriers are also having a significant impact on the environment for research and manufacturing companies. Flexibility without loss of quality must therefore always be weighed against realization and product costs.
Factory planning can achieve this methodically in various forms and depths. Some examples from our practice show how complex the factory planning environment is.
After mergers or company acquisitions, plants are often used differently. However, new needs and requirements usually entail drastic changes to plant logistics and in particular to the flow of people and materials. With dynamic simulation, different scenarios can be compared and evaluated virtually but in a well-founded manner in Site Master Planning - long before the costly experience in reality would reveal it.
New market and marketing requirements trigger conversions and adjustments to the production program. The technical and financial assessment of the feasibility of conversions and upgrades within existing premises and existing infrastructure is therefore a central task of factory planning.
The possibility of production locations for global demand, favored by reduced trade barriers and new tax incentives, influence production concepts, batch sizes, supply chain and storage capacities. Factory planning can meet these requirements flexibly and at an early stage.
New dosage forms (e.g. parenteral sustained-release applications), but also new production methods (e.g. cell culture fermentations), require higher-quality sterile conditions both in the manufacture of active pharmaceutical ingredients (API) and in the production of final forms. The implementation of sterility requirements for the effective prevention of contamination must - in addition to the process control itself - also be incorporated into the process architecture.
Factory planning for the highly regulated industry requires systematically working experts who have deepened their knowledge not only technically, but also with regard to the customer industry.
The entire Chemgineering Group relies on such experts who are committed to the markets, technologies and products of their customers.
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