GIU PHEN 504 Environment, Health and Safety Lecture 1 (PDF)

9/20/2024 Pharmaceutical Engineering Department Course PHEN 504 “Environment, Health and Safety” Lecture # 1 Introduction to EHS in Pharmaceutical Manufacturing...

9/20/2024 Pharmaceutical Engineering Department Course PHEN 504 “Environment, Health and Safety” Lecture # 1 Introduction to EHS in Pharmaceutical Manufacturing Dr. Asmaa Hamouda Associate Professor of Chemical and Environmental Engineering 19/09/2024 Outlines Summery of instructor profile Aim of the course Learning outcomes Course content Assessment methods Lecture 1 – objectives What is EHS? Why is EHS Important in Pharma? Key Regulations in EHS for Pharmaceuticals (Tutorial Session) Environmental Protection in Pharma Worker Health and Safety Role of EHS in preventing contamination and ensuring product safety Examples of drug recalls due to EHS issues Key Elements of EHS Management Systems Environmental Risk Assessment in Pharma Best Practices for EHS in Pharmaceutical Manufacturing Future of EHS in the pharmaceutical industry Conclusion 1  9/20/2024 Education Institution Degree(s) or Diploma(s) obtained: Faculty of Engineering, Ph.D. (Integrated Hazardous Waste CED. Management and Environmental 2008-2010 Assessment, case study of PCBs) National Planning Diploma in Environmental Institute Planning, Management and 2003-2004 Sustainable Development. Faculty of Engineering, M.Sc. (Industrial Wastewater CED, Treatment of Dairy Industry, Design 1998-2005 a Industrial Wastewater Unit, Complete feasibility study of the WWP). Faculty of Engineering, B.Sc. In Chemical Engineering. CED 1993-1997 Consultant Certificates Authority Certificate(s) obtained: [ Date from - Date to ] Egyptian Engineers Consultant in the field of Environmental Syndicate, 2013-Present Management Egyptian Environmental Consultant in the field of preparation of Affairs Agency, EEAA. Environmental Assessment Studies and 2015-Present official reviewed. Egyptian Environmental Consultant in the field of preparation of Affairs Agency, EEAA. Environmental Prevention studies. 2022-Present Consultant in the field of Integrated Management of Hazardous waste and Materials. OSHA (Occupational Certified OSHA Auditor Occupational Safety Safety and Health and Health Standers for : Administration) General Industry 2011 Standers for Construction Industry. 2  9/20/2024 Member in  The National Authority for Quality Assurance and Accreditation of Education “NAQAAE”, Certified Auditor for HE 2022-Present  Applied Research and Sustainability committee, Center of Excellence of water in Egypt COE, USAID/AUC funded Project, 2019- Present.  JICA Alumin Association, since 2007-Present. 2023-Present (JICA Alumin Board.)  Egyptian Engineers Syndicate, 1998-Present  Higher Education Reform Experts committee (HEREs) funded from EU, Deputy Chairman, 2015-2016.  Ministerial committee for the Using alternative fuels/Coal as a new primary fuel in the cement factories 2012-2013  Environmental Committee in the Egyptian Syndicate of Engineers in Egypt, 2013-2014.  The Egyptian General Organization for Standardization and Quality “EOS”, 2012-2013  Federation of Arab Engineers, 2012-2013 Carriers(1997-Present) 2021-2024: Head of Environmental Department, PSAS-BSU 2013-Present : BSU/ (1) Associate Professor in Beni-Suef University, PSAS. (2) Consultant of EIA, CAP, Waste Management, POPs/ ESIA under the Sustainable Persistent Organic Pollutants Management Project (SPMP)/GEF- WB. (2015-2017) Adjunct Assistance Professor in Zewail city for science and technology (2000-2013) Egyptian Environmental Affairs Agency. – Director of Industrial Environmental Impact Assessment (EIA) Department (2008-2013). – Advisor of the Environmental Minister (2012/2013) – Deputy Manager and project coordinator/Solid and Hazardous General Department, (2006-2008) – Coordinator, Planner and Environmental Inspector, Environmental Inspection Department (2000-2006) 1997-2000: Chemical and Environmental Engineer/Chemonics Egypt – Environics Co. 3  9/20/2024 Research Philosophy Supervised Thesis 31 Awarded Thesis 18 Master 14 PhD 4 h-index (ResearchGate)/Scopus 10 Citations 313/253 Total Publication 2005-July 2024 46 PHEN 504 Environment, Health and Safety COURSE IN FIGURES 4  9/20/2024 Aim of the Course Introduces the concepts of environmental impact, industrial hygiene and health and safety. Introduces the concepts of Life Cycle Assessment (LCA) approach and the sustainability Introduces the basic of the circular economy and how they apply to the pharmaceutical industry. It also addresses industrial hygiene and contamination control and The different health and safety hazards in the pharmaceutical industry and how to mitigate them. What are your expectation from This Course? 5  9/20/2024 Learning Outcomes a. Knowledge and Understanding 1. Describe the different aspects of the environment and how it can be impacted by human activities. 2. Describe the health hazards associated with a pharmaceutical process. 3. Identify operational controls to reduce and mitigate environmental, health and safety hazards associated with a pharmaceutical process. 4. Describe the relevant regulatory requirements for health and safety in the pharmaceutical industry. b. Intellectual Skills 1. Assess the environmental impact of an industrial process. 2. Assess the health and safety hazards of an industrial process. c. Professional and Practical Skills 1. Design measures in a pharmaceutical process to mitigate environmental, health and safety hazards. 2. Analyze the complexity of environmental issues in the pharmaceutical industry. Course Content 1 Week 1: Introduction to EHS in 7 Week 7: Environmental Pharmaceutical Manufacturing Sustainability in Pharmaceutical Manufacturing 2 Week 2: Hazardous Materials 8 Week 8: Occupational Health and Management Safety Risk Assessment 3 Week 3: Chemical Safety and 9 Week 9: Process Safety and Incident Exposure Controls Prevention 4 Week 4: Biological Safety and 10 Week 10: Fire Safety and Emergency Containment Preparedness 5 Week 5: Ergonomics in 11 Week 11: Regulatory Compliance Pharmaceutical Manufacturing and Auditing 6 Week 6: Waste Management and 12 Week 12: Course Wrap-up and Case Pollution Control Studies 6  9/20/2024 Assessment Methods Student Assessment Methods Percentage Final Exam 40 Mid-Term Exam 20 Quizzes 10 Project 10 Assignments 20 Course Instructor Instructor TA Dr. Asmaa Hamouda Eng. Donia Office Hrs.: Thursday 11:00 am- 1:00 pm 7  9/20/2024 Lecture # 1 Introduction to EHS in Pharmaceutical Manufacturing Lecture 1 - Objectives Understand the significance of EHS in pharmaceutical manufacturing. Learn about key regulatory agencies and their roles. Explore the link between environmental protection, worker safety, and public health. 8  9/20/2024 What is EHS? EHS stands for Environmental, Health and Safety. It’s a discipline aimed at protecting human health and safety by minimizing hazards in the workplace, environment, and communities. EHS professionals often work to prevent accidents, injuries, and illnesses while also addressing environmental concerns like pollution and waste management. What is EHS? EHS encompasses various aspects including: identifying and assessing risks, implementing safety measures and protocols, ensuring compliance with regulations, and promoting a culture of safety within organizations. 9  9/20/2024 Why is EHS Important in Pharma? Ensures compliance with legal and regulatory standards. Prevents accidents, injuries, and environmental damage. Promotes sustainable and ethical manufacturing practices. Key Regulations in EHS for Pharmaceuticals Overview of regulations: OSHA, EPA, FDA, WHO guidelines. How these regulations impact pharmaceutical manufacturing. The role of EHS in GMP (Good Manufacturing Practices). Tutorial 1 10  9/20/2024 Overview of Regulatory Agencies OSHA: Occupational safety, hazardous materials. EPA: Environmental protection, pollution control. FDA: Ensuring drug safety, contamination control. WHO: International guidelines and harmonization Environmental Protection in Pharma Minimizing air, water, and soil contamination. Importance of proper waste management. Clean Technologies and Environmental Policy https://doi.org/10.1 007/s10098-019- 01766-1 11  9/20/2024 Environmentally Persistent Pharmaceutical Pollutants (EPPPs) | UNEP - UN Environment Programme 12  9/20/2024 Worker Health and Safety Importance of worker protection in pharma. Hazard identification: chemical, biological, and ergonomic risks. Safety protocols: PPE, air quality controls, ergonomic equipment. Role of EHS in preventing contamination and ensuring product safety-The Pillars of Success CAPAs: It means investigating the source of contamination and taking the specific actions CI: Continuous Improvement https://www.pda.org/pda- letter-portal/home/full- article/contamination- control-strategies-a-path- for-quality-safety 13  9/20/2024 Examples of drug recalls due to EHS issues Some health risks associated with certain medications are not realized until after they become widely used. For example, in 2000, medicines containing the drug phenylpropanolamine (PPA), such as certain decongestants (Antihistamines) and weight loss medicines, were recalled after learning that PPA increases the risk of hemorrhagic stroke, or bleeding in the brain. Another example is the weight loss drug sibutramine (Meridia). Meridia was recalled from the U.S. market in 2010 after it was found to increase a person's risk of heart attack and stroke Key Elements of EHS Management Systems https://www.linkedin.co m/pulse/benefit- implementing-ohs- management-system- your-ian-peters-q85fe/ 14  9/20/2024 American National Standards Institute (ANSI) The Ultimate Guide to Safety Management Systems - Safesite (safesitehq.com) Environmental Risk Assessment in Pharma An environmental (risk) assessment (ERA) involves analyzing the hazard profiles to identify the potential risks associated with Pharma. compounds on environmental organisms and Media. 15  9/20/2024 Best Practices for EHS in Pharmaceutical Manufacturing Sustainable manufacturing processes. Continuous monitoring and reporting. Employee involvement in EHS initiatives What is GMP | Good Manufacturing Practices | SafetyCulture 16  9/20/2024 Ensuring Operational Excellence: A Comprehensive Guide to Stability Programs in cGMP Compliance | by USSFGMP | Medium Future of EHS in the pharmaceutical industry Future of EHS in the pharmaceutical industry is driven by: 1. Innovation 2. Sustainability 3. The global push toward a circular economy. 17  9/20/2024 Innovative technologies, such as flow chemistry and biocatalysis, are achieving not only sustainability goals but also unprecedented levels of quality and efficiency Advanced Technologies The use of artificial intelligence and robotics in sorting facilities will improve the efficiency and accuracy of waste separation, reducing contamination and increasing the value of recycled materials -1- Innovation Hubs AI and Robotics Innovation Establishing innovation hubs dedicated to waste-to-resource technologies will drive the development and scaling of new solutions Advanced Chemical Recycling: Unlike traditional Recycling mechanical recycling, chemical recycling Technologies processes can break down complex plastics into their basic monomers, allowing for the production of new, high- quality plastics The Internet of Things (IoT) will enable real-time monitoring of waste streams, optimizing collection, sorting, and processing to maximize resource recovery Smart Waste Management More communities will adopt zero- waste initiatives, focusing on reducing waste at the source and maximizing recycling and composting efforts Global -2- Zero-Waste Collaboration Sustainability Communities International Standards: Countries will work together to establish global standards for waste management and resource recovery, facilitating the exchange of best practices and technologies Consumer Awareness and Consumer awareness campaigns will Behavior become more widespread, educating the Change public on the importance of waste reduction, recycling, and supporting sustainable products 18  9/20/2024 Future products will be designed with their end-of-life in mind, making them easier to disassemble and recycle. This approach is central to the concept of a circular economy Product Design for Circularity Companies will increasingly adopt industrial symbiosis, where the waste or by-products of one industry become the raw materials for another. This will create closed- loop systems that minimize waste Resilient and -3- Industrial Adaptive Circular Symbiosis Systems Economy Decentralized waste processing facilities will reduce the need for long-distance transportation of waste, making resource recovery more localized and adaptive to specific community needs Extended Producer Governments will increasingly adopt EPR Responsibility policies, requiring manufacturers to take (EPR) responsibility for the entire lifecycle of their products, including post-consumer waste Future of EHS in the pharmaceutical industry Environment: improved product traceability(Improved product traceability can help chemical manufacturers accurately and efficiently report which chemicals were used in different processes and products) Health: early detection of dangerous working conditions(For example, gas leaks can be both fatal to employees and environmentally damaging. Pairing automated monitoring with an alerting system can notify teams about gas leaks on specific pieces of equipment even if the leak is not detectable by scent or visible inspection) Safety: anticipating breakdowns earlier (predictive maintenance strategy) 19  9/20/2024 Conclusion Environment, Health, and Safety measures have been at the lead of chemical/Pharmaceutical manufacturing for nearly 40 years. Today’s technologies can help companies make further advancements in their EHS strategy. Improved condition monitoring, better product traceability, and wider data visibility all play a role in making chemical/ Pharmaceutical manufacturing safer for both employees and global communities. These tools also play a large role in communicating EHS information between employees, teams, or facilities. When information and successes are easier to share and scale, companies can advance valuable EHS initiatives faster and with greater confidence. References OSHA: www.osha.gov EPA: www.epa.gov FDA: www.fda.gov WHO GMP Guidelines: www.who.int ICH EHS Guidelines: www.ich.org Pharmaceutical Manufacturing Handbook by Shayne Cox Gad. World Bank EHS Guidelines for Pharmaceutical Manufacturing. 20  9/20/2024 Assignment #1 2 Points Why is EHS Important? Elaborate your answer with one case study? What are the responsibilities of an EHS Manager Watch the Videos: https://www.youtube.com/watch?v=CiHxfhQ2 Mw4 https://www.youtube.com/watch?v=IZVxBlX18 Dw (Environment, Health & Safety (EHS) Effectiveness) Send the Assignment during a week, the dead time is Wednesday 25 Sept. 2024 at 6:00 PM. Email: [email protected] Thank You Photos were taken by Asmaa Hamouda, Logan-Utah , USA, January-May 2024 21