Sustainability Report 2014 Lek d.d.

33 Environment 2.2.6 Abandoning the use of hazardous volatile organic compounds By replacing hazardous VOCs with less hazardous sub- stances, Lek has significantly improved the tablet film- -coating process. With continuous measures we are reducing the level of environmental pollution with hazardous waste and additionally lowering the VOC emissions into the air. At the Prevalje site, the studies for replacing the etha- nol phase by the water phase in the film-coating process were continued after methylene chloride had been fully re- placed with ethanol in 2011. At the Ljubljana site we have successfully completed the project of replacing ethanol- -based coating of one category of omeprazole with water- -based coating. The regulatory approval of the change to the technological procedure was obtained in 2014. The Menge‰ site also endeavours to replace more hazardous chemicals with less hazardous ones – in 2014, a modified production process of one of the active ingredients was successfully im- plemented and the use of dichloromethane was eliminated from the technological process. Uro‰ Ur‰iã, Head of operational development at Menge‰ Interview Every planned activity should be performed safely Uro‰ Ur‰iã, Head of operational development at Menge‰ explains that a series of successful optimization process examples also have a positive environmental impact, because development processes always include environ- mental aspects. Developing new products is key for all companies with a vision of growth. What is the role of the operational developments as part of API Menge‰ in developing products and ensuring the growth of the company? The operational development is based on three main pillars which are solving production issues, optimiza- tion of manufacturing of already launched products and transfer of new products into production. The objective of process optimization is to improve the price competitiveness of our products, while consider- ing other aspects as well. When developing improved processes, our laboratory always considers environ- mental aspects as well. Accordingly, when developing a new process for the synthesis of one of our active ingredients – mycophfenolate mofetil (MMF), we elimi- nated the use of dichloromethane and oxalyl chloride as reagent. Handling the latter namely requires special protective measures due to the formation of hydrogen chloride and carbon monoxide. Where possible, regeneration of waste solvent is being intro- duced into all our development processes, making an important contribution to sustainable growth. Together with our colleagues from Production, we reduced the use of dichlomethane to 10% of the original volume, by re-using it. What is particularly important for the successful trans- fer of products into production? The transfer is successful, if the planned quantity of the product of adequate quality is manufactured during the transfer and the validity of the production process is confirmed. The path to achieving this is difficult. It is necessary to take into account a whole range of differ- ent and also indispensable aspects. Let me mention a few: a robust process with clearly developed and properly defined critical process points and critical material attributes, appropriate analytical methods, availability of raw materials, suitable processing equip- ment and also correctly evaluated aspects of safety, health and the environment. The transfer is therefore successful only if care is taken that the process is carried out in a safe manner and without impacting human health and the environment. This is a difficult path to take, it is necessary to take into account a whole range of different and indispensable aspects. When making decisions on technological solutions, how important are their impacts on the environment? My view is that our work is based on two pillars where there are no ‘concessions’. The first one is quality assurance which in our industry goes beyond mere adequacy of products. The second, also im- portant area, are aspects of health, safety and environment which are interconnected. In all our new projects, the safety concern is a key factor in decision-making. For each planned activity we have to ensure that it will be carried out safely in order to preserve the health of our employees as well as the sustainability of the environment.