HUNGARIAN JOURNAL OF INDUSTRIAL CHEMISTRY VESZPREM Vol. 29. pp. 155-160 (2001) APPLICATION OF LIFE .. CYCLE ASSESSMENT FOR A PHARMACEUTICAL PRODUCT K. HERNER, J. REDEl, L. TAMASKA, Sz. VIZI and A. REDBY (Department of Environment Engineering and Chemical Technology, University ofVeszpn!m, Egyetem st. 10., Veszprem, H-8200, HUNGARY) Received: November 22, 2001 In this paper the object is a life-cycle assessment (LCA) of a pharmaceutical product. The target of the analysis is to compare different packaging alternatives from environmental aspect. The product is an antidepressive produced by one of the leading Hungarian pharmaceutical factories. In the market the product appears as injection and as a pill packaged in two different ways, in glass bottle and in blister (aluminium and plastic foils laminated together). These three systems: injection, glass and blister are compared in this paper using LCA. Keywords: pharmaceutical product, life-cycle assessment (LCA), packaging alternatives Introduction Pharmaceutical products as well as other products have certain affects on the environment during their entire life-cycle. The life-cycle of a product means the steps from the excursion of the raw materials, the production, the usage of the product to the waste management. The affect depends on the raw material of the product, the technology, and the waste management as well as the function of the product. LCA [6] is a method used for analysing the environmental effects connected to a given product and it gives an overview of the contribution to the environmental problems during the life-cycle stages of the product. It deals with data of the material and energy usage, the emissions and waste output, connecting them to the following environmental effects: • Greenhouse effect • Ozone depletion • Acidification • Eutrophizaton • Heavy metal • Carcinogenic • Winter smog • Summer smog • Pesticide In this way the environmental performance of the ?roduct can be clarified so the priority for the Improvements can be done. By using the method the differentiation between products, raw materials or energy sources is becoming possible by environmental aspect. Thus LCA is a tool of the cvntmuing environmental development and a tool for the environmental performance improvement of the product or firm [5]. Environmental analysis method LCA is an internationally accepted and applic:d environmental management tool for improving the environmental performance of a product or for comparing alternative products. The ISO 1404049 (.t] · international standards contain the basic principles of the analysis but the method can differ as they are under development in several parts of the world. The method used for this analysis is the Eco- Indicator 95 method, developed by Preconsultants B.V. in the Netherlands and an LCA software called SimaPro 4.0 developed by the same firm. The principles of the method are explained by Goedkoep et al. t 1996} {2}. The software uses the same method. Eco-Indicator 95, but it simplifies the calculations. the results are histograms and tables. The hist{lgrams "an give the following information: the relative contrihuti,m to the environmental effects of the materials and processes during the product life-cycle (characterint~t'n). which environmental effects are bigger (normah7.ationJ. the relative importance of the effects tvalUJ!f\lnl. beside~ 156 these~ the life-cycle stages of the product become comparable (indicator) [2]. The reliability of data is important for the analysis. A part of data is based on the software database while other data originate from the pharmaceutical firm ·[1]. Data missing from both sources was developed by our own publications and handbooks mentioned in the references [7-10]. Life-cycle stages of the product The first step is the production of the elementary substance and the production of the effective substance of it. Then a part of the effective substance is granulated and pearled, the result is dragee, while injection is made from the other part of the effective substance. The next step of the technological process is packaging: injections in 2 ml glass ampoules, dragees in 15 g glass bottles with PE bottle caps and cotton-wool damper or PVC and aluminium blisters. Life-cycle stages of the product continue through the distribution to the waste management. All the stages of the process involve material and energy input, emissions to water and air and waste output. Waste treatment in this case means landfill or incineration. Packaging processes Dragee packaging A part of the pharmaceutical products are packed in 15 g glass bottles with written tickets and collected in loose cards. The following materials are used for dragee packaging: • Pill • Glass material • Cotton~wool • Paper products (tickets~ loose-cards, consignment note) • Others (PE bottle-cap, adhesive tape) Blistering The other part of the piUs packed in blister~ which is a cut and signed PVC-aluminium packaging form. Materials used for the packaging: • Pm • Primary packaging materials: PVC, PVCIPVDC foil~ aluminium fod • Secondary packaging materials: tickets. boxes, loose-cards. • Packaging with complement information: consignment note. tickets. • Auxiliary materials: paints, reducer, PE tape for bundle (60 mm wide, 40-50 J.Un thick PE foil), sticking tickets (50 mm in diameter), plastic adhesive tape. Blister is made of PVC and PVC/PVDC foil and printed aluminium foil closed with welding. Packaging of injection: The 5 pieces of 2 ml injections are placed in one hard, covered, white PVC foil. Two of these PVC foils are placed in one loose-card provided with a consignment note. This means there are 10 injections of 2 ml in one package. Distribution Pharmaceutical end-products are going to the next step of the distribution chain: from the factory to the wholesalers and from these through the pharmacies and hospitals to the consumers. Waste management It was assumed that the packaging of the pharmaceutical product becomes waste at the consumer and treated as household waste. As household waste most of it is deposited in landfills. Waste generated through the processing is incinerated as industrial waste. Life-Cycle Assessment for the pharmaceutical product Analysis is made for the following steps of the products life-cycle: • Elementary substance • Effective substance • Production and packaging of the injection • Production and packaging in glass bottles of the dragee • Production and packaging of the dragee in blisters Since the object of this analysis does not extend to the effects of the elementary and effective substances and to the changes of these effects, and since these effects are included in the analysis of packaging forms, this paper only deals with the analysis of the three packaging forms. For the analysis, SimaPro 4.0 software was used, the results are presented in histograms below [2]. There are four types of histograms. showing the different aspects of the environmental loads connected to the materials and processes of the life-cycle steps [3]. Characterization: The histogram shows the contribution of the technological steps to each environmental problem in percentages. energy oolid BJISiorchkompotatoeo bJGiooo"' tzlLaclo>o m>~oorin []Tole (SIG<>In- bJGilcooo 0L- tc- !];T'*' !S!G<>In>~Jg g~- ~pM!icid !Jl'"""W []ooi:i -~~-,;;;p:c~~s~aiiE~·iirfu;;p;ii/~----·--·--··-·--·-·--·····-··--·-··--·---··-· ·· Fig.6 Indicator histograms of dragee in glass, dragee blister and injection forms. Between the two packaging alternatives for the dragee form the glass packaging seems to be better from environmental aspect, the differences is almost 20%. This alternative is better in the following environmental problems: carcinogenic, ozone depletion, acidification, while it is worth in heavy metals as the blister packaging. Summarising the dragee form packed in glass is the best solution from environmental aspect. The injection form of the pharmaceutical product has the biggest effect on the environment, but its function is differs so it cannot be changed. Conclusions By the assessment of the product life-cycle we got a view on the potential environmental load. The most important environmental problems, which occur through the entire life-cycle of the pharmaceutical product are acidification, carcinogenic and heavy metals. The acidification is mainly caused by the elementary substance production, and extracting solvents in it. Through the effective substance production the contribution of the organic acids is important. Besides these, the S02 and NOx emissions from the PVC plastic production also generate acidification. This occurs at the dragee blister form of the pharmaceutical product. In addition, at dragee covering S02, at dragee packaging NOx and at the elementary substance! ammonium is emitted. Carcinogenic effect is mainly caused by the poliaromatic-hydrocarbons and nickel emitted by aluminium foil production used for the dragee blister. Besides these the contribution of the emissions occurred at the energy generation and the diesel oil used for transportation at the elementary substance production is significant. By the dragee production the acid extraction and the diesel oil usage is responsible for the carcinogenic effect. Carcinogen effects by the injection form are caused by the benzene, benzpyrene, poliaromatic-hidrocarbons, chrome and nickel occurred at the energy generation and the poliaromatic~ hidrocarbons and benzpyrene generated at the gas burning. 159 Heavy metal emissions of the pharmaceutical products are caused by the glas<) production, needed at the injection and dragee glass packaging forms. During the glass production the next heavy metals can occur and are emitted to air or water: Pb, Ba, Cr, Ni, As Cd, Hg, Cu. Besides these the antimonies, arsenic, cadmium and barium emission also cause heavy metal effect, which occurs in the fly ash originated from the energy generation. Some of the elementary substances also have a contribution to the heavy metal problem because of the energy generation. Mercury emission occurs at mercury-pool cathode acid production used in the elementary and effective substance production. Pb, Ni, Cr, Ba, As emission can occur during the aluminium production for dragee blister packaging form. Dragee covering also has a contribution to these effects. The previous shows that the main part of the potential environmental effects are originated from the packaging, so the conclusion is that it is worth paying attention to the alternative solutions and choose the right and most environmentally friendly one. This harmonizes the interests of the pharmaceutical factory, the interests of the environment and the interests of the environmentally conscious customers in order to satisfy the environmental demands which are an important part of the competitive position. Figure 6, which compares the packaging alternatives with the same effective containment, shows that the dragee form packed in glass bottle is the best from environmental aspect. The next is the dragee blister form and the injection form seemed w have the mnq environmental loads. Inspite of these fa~ts the injectw1~ form is needed in hospitals and surgerie~. Finally, the result of the analysis is that besides the effects of the packaging, the production of the pharmaceutical product causes the most potential environmental effects. The reduction of the environmental load connected to the product <: