İlaç sektörü için fabrika boyutunda çevresel analizler ve risk değerlendirmeleri
Factory-scale environmental analyses and risk assessments for the pharmaceutical industry
- Tez No: 999081
- Danışmanlar: PROF. DR. AHMET ÇELEBİ
- Tez Türü: Yüksek Lisans
- Konular: Çevre Mühendisliği, Environmental Engineering
- Anahtar Kelimeler: Belirtilmemiş.
- Yıl: 2026
- Dil: Türkçe
- Üniversite: Sakarya Üniversitesi
- Enstitü: Fen Bilimleri Enstitüsü
- Ana Bilim Dalı: Çevre Mühendisliği Ana Bilim Dalı
- Bilim Dalı: Çevre Mühendisliği Bilim Dalı
- Sayfa Sayısı: Belirtilmemiş.
Özet
Araştırmanın temel amacı, ilaç sektöründe faaliyet gösteren bir fabrikada gerçekleşen faaliyetler üzerinden ilaç üretim süreçlerinden kaynaklanan çevresel boyutları sistematik olarak belirlemek, bu boyutlara bağlı tehlike ve riskleri analiz etmek, tesisteki mevcut kontrol önlemlerinin etkinliğini değerlendirmektir. Ayrıca, belirlenen risklerin çevreye ve canlılara etkisini değerlendirerek bu risklerin ortadan kaldırılması veya kabul edilebilir seviyelere düşürülmesi için eylem planları geliştirmek hedeflenmiştir. Araştırıma, Sakarya ilinde faaliyet gösteren özel bir ilaç fabrikasında yürütülmüştür. Değerlendirme sürecinde; çevre mevzuatına ilişkin hukuki ve diğer yükümlülükler, yasal mevzuat şartları, kaza ve olay kayıtları, iç tetkik sonuçları, olağandışı durum raporları, mevcut çevresel önlemler, proses akım şemaları, malzeme envanterleri (hammadde, kimyasal, atık vb.), araştırmacı tarafından sahada yapılan gözlemler ve çalışanlarla gerçekleştirilen görüşmelerden elde edilen geri bildirimler ile hammadde, ürün, kimyasal ve atıklara ilişkin malzeme envanterleri temel veri kaynakları olarak kullanılmıştır. Verilerin sistematik kaydı için Risk Değerlendirme Formlarından yararlanılmıştır. Bu girdiler doğrultusunda ürün, faaliyet ve hizmetlerden kaynaklanan çevre boyutları tanımlanmış ve risk düzeyleri olasılık ve şiddet parametreleri üzerinden değerlendirilmiştir.Araştırma kapsamında, ilaç fabrikasında ortaya çıkabilecek çevresel riskler 5x5 Matris Yöntemi kullanılarak analiz edilmiş; klasik risk değerlendirme yaklaşımına ek olarak çevre mevzuatı gereklilikleri de puanlama sürecine dâhil edilerek özgün bir risk puanlama sistemi geliştirilmiştir. Çalışmada fabrikanın 16 farklı departmanı analiz edilmiştir. Yapılan analizler sonucunda elde edilen araştırma bulguları, ilaç fabrikasında yürütülen faaliyetlerin çevresel risk profillerinin birimler ve süreçler bazında farklılık gösterdiğini ortaya koymaktadır. Olasılık, çevresel çıktının toprak, su veya hava ortamına ulaşma ihtimali üzerinden; şiddet ise gerçekleşmesi durumunda insan sağlığı, doğal çevre, hedefler ve faaliyetler üzerindeki etkiler dikkate alınarak değerlendirilmiştir. Laboratuvar (14 adet 'Çok Önemli' risk) ve Üretim birimleri en kritik alanlar olarak saptanmıştır. Su sistemlerinde 5, atıksu arıtma departmanında ise 4 adet 'Çok Önemli' risk seviyesine sahip boyut tespit edilmiştir. Mevcut ve önerilen kontrol önlemleri (eğitim, sızdırmazlık, atık ayrıştırma vb.) sonrası yapılan artık risk analizi, başlangıçta 'Çok Önemli' olan risklerin büyük çoğunluğunun 'Önemli' veya 'Az Önemli' seviyelerine düşürülebildiğini kanıtlamıştır. Ayrıca, ilaç endüstrisinin çevresel etkilerini matematiksel bir modele dökerek yönetilebilir kılmış ve“sıfır kaza, minimum atık”hedefine ulaşmak için operasyonel bir yol haritası çizmiştir. Elde edilen sonuçlar, çevresel risklerin dinamik bir yapıya sahip olduğunu ve mevzuat gerekliliklerinin risk önceliklendirmesinde belirleyici bir rol oynadığını göstermektedir. Bulgular doğrultusunda, yüksek riskli çevresel boyutlar için iyileştirme alanları belirlenmiş ve çevresel performansın artırılmasına yönelik öneriler geliştirilmiştir.
Özet (Çeviri)
The pharmaceutical industry, despite producing high value-added products, is among the sectors that can place significant pressure on the environment due to intensive energy consumption in production processes, the use of numerous chemical substances, and the emergence of pharmaceutical active ingredient residues. Raw materials, solvents, auxiliary chemicals, and cleaning agents used in pharmaceutical production can cause persistent pollution in soil, water, and air environments if not properly managed. Environmental outputs arising particularly during production, laboratory, storage, maintenance, and waste management stages carry risks that could disrupt ecosystem balance. In this context, the environmental impacts of pharmaceutical factories must be addressed not only through results but also through a process-based and preventive approach. Pharmaceutical manufacturing plants are classified as“hazardous”and“highly hazardous.”Therefore, it is crucial for businesses operating in the pharmaceutical sector to be vigilant about occupational health and safety and to undergo regular inspections. This study aims to assess environmental hazards and the potential dangers and risks arising from these hazards in a pharmaceutical factory. The aim is to evaluate the impact of the identified risks on the business, personnel, environment, and other living beings, develop recommendations for prevention or risk reduction, and include them in the action plans of similar businesses. In factory-type and large-scale workplaces, the systematic identification of environmental hazards during the planning stages of existing working conditions or new investments is of great importance. The assessment of environmental risks is a critical management tool not only in terms of preventing possible environmental pollution but also in terms of ensuring legal compliance, protecting corporate reputation, and achieving sustainable production goals. Therefore, environmental dimension analyses are considered an indispensable tool for identifying hazards, assessing risks, and determining measures to eliminate risks at their source or, where this is not possible, to reduce risk levels. The main objective of this study is to comprehensively and systematically identify the environmental dimensions arising from drug production processes, based on the activities carried out at a production facility operating in the pharmaceutical sector. In this context, the study aims to analyze the hazards and risks that may arise in relation to the identified environmental dimensions, evaluate the adequacy of the existing environmental control measures implemented within the facility, and identify areas for improvement to reduce environmental risks. Furthermore, the potential impacts of environmental risks on the natural environment, human health, and living organisms are addressed from a holistic perspective, aiming to develop feasible action plans to either completely eliminate these risks or reduce them to acceptable levels. The research was conducted at a private pharmaceutical factory operating in the province of Sakarya. The universe of the research consists of a private pharmaceutical factory operating in the province of Sakarya. The structures and units belonging to the pharmaceutical factory examined within the scope of the research were evaluated. Risk assessments at the pharmaceutical factory were made taking into account the potential hazards that could occur throughout the area. The study aimed to provide an overview of the hazards and risks that could occur in the pharmaceutical industry and to present a guiding action plan. A multifaceted and comprehensive data collection strategy was adopted in the study. In this regard, legal and other obligations related to environmental legislation, current legal regulations, accident and incident records from previous periods, internal audit results, and unusual situation and emergency reports were examined in detail. In addition, existing environmental control measures, process flow diagrams, technical information on production lines, and material inventories related to raw materials, chemicals, products, and waste were included in the assessment process. Observations made by the researcher in the field, semi-structured interviews with employees, and feedback obtained were also used as qualitative data sources to support the analysis process. Once environmental interaction diagrams—that is, which department uses which input and produces which environmental output (waste, emissions, discharges, etc.)—have been clarified, the next critical steps in the planning phase of the EMS life cycle begin. The main phase following the determination of these diagrams is the Environmental Aspect Analysis (EAA). Risk assessment in the pharmaceutical industry stands out as a critical management tool due to both the production of products that directly affect human health and processes that interact intensively with the environment. In particular, factors such as the use of chemicals, waste generation, emissions, and energy consumption bring with them environmental, operational, and legal risks. In this context, risk assessment is approached as a comprehensive process that involves the systematic identification of potential hazards, the analysis of the likelihood and effects of these hazards, and the determination of appropriate control measures (ISO, 2018). An effective risk assessment approach in the pharmaceutical industry not only ensures compliance with regulations but also contributes to strengthening corporate sustainability. Risk Assessment Forms were used to evaluate the collected data in a systematic, traceable, and comparable manner. Through these forms, the environmental dimensions arising from products, activities, and services were defined; risk levels for each environmental dimension were assessed based on probability and severity parameters. In the probability assessment, the likelihood of the environmental output reaching the soil, water, or air environment was taken as the basis; in the severity assessment, the effects on human health, the natural environment, corporate goals, and operational activities in the event of the risk occurring were taken into account. The 5x5 Matrix Method was used to analyze environmental risks within the scope of the research. However, one of the unique aspects of the study is that it goes beyond the classic risk assessment approach by including environmental legislation requirements in the risk scoring process. The risk value was calculated by multiplying“Probability x Severity”; in addition, the“Legislation Multiplier (M)”, which gave the study its uniqueness, was integrated into the system. This ensured that environmental dimensions involving legal obligations were prioritized by increasing their total risk score, and that the legal dimensions of environmental risks, not just the technical ones, were also considered in the decision-making process. As part of the research, 16 different departments of the factory were analyzed in detail. The departments evaluated at the factory were water systems, production planning, machine maintenance, production, production-2, calibration, wastewater treatment, energy management, hazardous and non-hazardous waste temporary storage area, laboratory, project and installation/HVAC/auxiliary operations, cafeteria-toilets-washrooms, infirmary, offices, in-process, and others. Almost all environmental aspects initially classified as“Very Important”(37-75 points) have been reduced to 'Important' or“Less Important”levels thanks to the proposed or existing control measures (waste separation, training, leak prevention, discharge analyses, etc.). In this context, it can be said that the risk reduction success of the assessments carried out is high. The findings of the thesis prove that environmental dimensions in the factory (waste oil, hazardous solid waste, chemical wastewater, etc.) were concentrated in the“Very Important”category before control measures were taken, but could be reduced to 'Important' or“Less Important”levels after the recommended actions. The findings reveal that the environmental risk profiles of the activities carried out in the pharmaceutical factory show significant differences based on units and processes. Laboratory units were identified as the most critical areas with 14“Very Important”risk levels; production units also attracted attention with their high risk profile. Furthermore, 5 environmental dimensions with a“Very Significant”risk level were identified in water systems and 4 in the wastewater treatment department. These results indicate that processes involving water contact and areas with high chemical concentration should be prioritized in terms of environmental risk. Post-risk analyses conducted after implementing existing and proposed control measures revealed that a significant portion of the risks initially classified as“Very Significant”could be downgraded to 'Significant' or“Less Significant”levels. Measures such as increasing training activities, strengthening leak prevention practices, separating waste at source, and updating procedures have been found to be effective in reducing environmental risks. In this respect, the study has made the environmental impacts of the pharmaceutical industry manageable by converting them into a numerical and mathematical model and has provided a feasible operational roadmap towards the goal of“zero accidents, minimum waste.”The research findings reveal that environmental risks do not have a static structure but, on the contrary, can constantly change depending on production volume, chemicals used, regulatory changes, and operational conditions. Therefore, it is emphasized that environmental risk management must be approached as a dynamic process. Updating environmental dimension analyses in new projects or when working conditions change is considered a critical requirement for identifying risks at an early stage. Furthermore, it is recommended that raw material substitution, process improvement efforts, and waste hierarchy principles (prevention and reduction) be prioritized to reduce the risks posed by hazardous (H-coded) waste. In conclusion, this study demonstrates that environmental risks in the pharmaceutical industry can be addressed with a comprehensive, regulation-based, and quantified approach; it offers applicable and sustainable recommendations for improving environmental performance. The findings are considered to be of a nature that can guide environmental risk management practices in the pharmaceutical industry and can serve as a model for similar facilities.
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