Industrial Equipment and Design of Pharmaceutical Enterprises (курсовий проєкт)

Major: Industrial Pharmacy
Code of subject: 7.226.02.E.061
Credits: 3.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Andriy Mylyanych Professor Maryna Stasevych
Semester: 8 семестр
Mode of study: денна
Мета вивчення дисципліни: Training of specialists for work in the pharmaceutical industry and acquaintance of students with industrial equipment of chemical and pharmaceutical enterprises, its design features and application in chemical and pharmaceutical production, as well as with the basics of modelling and designing a chemical and pharmaceutical enterprise, taking into account safety requirements and GMP rules and regulations.
Завдання: The study of the discipline involves the development of the necessary competences in students: general competences: -GC2. The ability to know and understand the subject area and understanding of the profession; the ability to learn, perceive the acquired knowledge in the subject area and integrate it with existing knowledge; -GC6. Ability to search for and analyse information from various sources; ability to conduct research at the appropriate level, have research skills, which are manifested in the ability to form (preparing presentations or presenting reports) new products in the chosen field, choose appropriate directions and appropriate methods for their implementation, taking into account available resources professional competences: -PC5. Ability to use modern concepts in the field of modelling, scaling and validation of pharmaceutical production in the GMP system; ability to select the optimal parameters of the processes of production of pharmaceutical (including veterinary, medicinal and cosmetic) drugs and drugs from natural raw materials; -PC12. Ability to apply knowledge of the types of equipment for pharmaceutical production, features of application and principles of operation of various devices; ability to use theoretical knowledge and practical skills in the operation and modernisation of pharmaceutical production.
Learning outcomes: As a result of studying the discipline, the student should be able to demonstrate the following learning outcomes: - to know the peculiarities of application, design features and principles of operation of various types of equipment of chemical and pharmaceutical enterprises of domestic and foreign production, its use in various technological processes. - be able to choose industrial equipment for a specific technological process at a chemical and pharmaceutical enterprise; - carry out design calculations for a specific type of equipment. - know the basics of design technology and organisation of design work, features of designing production and auxiliary premises; basic principles of construction design of chemical and pharmaceutical production and principles of layout of technological equipment. - should be able to: design and model new technological schemes for the production of pharmaceuticals and chemical and pharmaceutical enterprises in general, taking into account safety requirements and GMP rules and regulations; comprehensively solve the issues of construction design using standard unified building structural elements and standard equipment.
Required prior and related subjects: Сo-requisites: Modelling, design and equipment of chemical and pharmaceutical enterprises in the GMP system, course project Industrial technology of pharmaceutical production part 2 Educational and research practice Execution of master's qualification work Defence of master's qualification work
Summary of the subject: The material on domestic and foreign equipment used at chemical and pharmaceutical enterprises, including materials for the manufacture of devices, technological features and structural elements of the equipment, processes of grinding, sieving, moving, mixing, dosing, pressing, amplification and drying is presented. The characteristics of the latest automated and semi-automated systems of chemical and pharmaceutical processes are presented. Technological calculations for equipment selection are considered. The material on the basic principles and methods of designing and modelling new technological schemes for the production of pharmaceuticals and chemical-pharmaceutical enterprises in general, taking into account safety requirements and GMP rules and regulations, is presented. The basic construction standards, materials and elements of industrial and auxiliary buildings of chemical and pharmaceutical enterprises are considered.
Опис: Features of processes and devices of chemical and pharmaceutical enterprises. Materials for the manufacture of pharmaceutical equipment. Equipment for mechanical processes. Equipment of the grinding process. Sieving of bulk materials. Feeders of solid materials in pharmaceutical production. Mixing of solid materials. Mechanisms for moving solid materials. Processing of materials by pressing. Equipment for drying in pharmacy. Amplification. Submitted material on basic principles and methods of designing and modeling new technological scheme of pharmaceuticals and chemical and pharmaceutical companies as a whole to meet the requirements and safety rules and regulations GMP. The main building codes, materials and components for manufacturing of industrial and auxiliary buildings of chemical-pharmaceutical companies.
Assessment methods and criteria: - Test control and oral examination at workshops on topics studied, written test and evaluation of individual tasks (30%); - Final evaluation (70% - control measure, exam), written-oral form (70%).
Критерії оцінювання результатів навчання: Current control consists of: written tasks (content and correctness of individual calculation and graphic work - 5 points, presentation and design - 2 points, answers to questions - 3 points) and test tasks and oral survey in practical and lecture classes. Questions of the examination ticket are evaluated: questions of the 1st level (questions 1-10) - 10 questions of 2 points each, in total - 20 points; II level (questions 11-12) – 2 questions of 10 points each, total – 20 points; III level (questions 13-14) – 2 questions of 15 points, total – 30 points. Level II and III tasks are supplemented with written (oral) justification of the chosen answer.
Recommended books: 1. Технологічне обладнання біотехнологічної і фармацевтичної промисловості: підручник [для вищ. навч. закл.] Стасевич М.В., Милянич., А.О., Стрельников Л.С., Крутських Т.В, Бучкевич І.Р., Зайцев О.І Гузьова., І.О., Стрілець О.П., Гладух Є.В., Новіков В.П. – Львів: «Новий Світ-2000», 2019. – 410 с. 2. Промислова технологія лікарських засобів: базовий підручник для студ. вищ. навч.закладу / Є. В. Гладух, О. А. Рубан, І. В. Сайко [та ін.] – Х. : НФаУ : Новий Світ-2000, 2018. – 526 с. 3. Моделювання і проектування хіміко-фармацевтичних підприємств в системі GMP: практикум / А.О. Милянич, О.В. Федорова, Н.Я. Монька, В.І. Лубенець. – Львів: Левада, 2023. – 184 c. 4. Настанова СТ-Н МОЗУ 42-4.0:2020 «Лікарські засоби. Належна виробнича практика» та додатки - наказ МОЗУ №1023 від 04.05.2020