Simulation and Scaling of Biotechnological Production in the GMP System (курсовий проєкт)

Major: Biotechnology and bioengineering
Code of subject: 7.162.00.O.011
Credits: 3.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Assistant, Ph.D., Natalija Monka
Semester: 2 семестр
Mode of study: денна
Learning outcomes: • to know the principles of design, an organization of design work and overall technology of cleanroom design for biotech enterprises and foundations of technological organizing of production; • to know the methodology of design and modernization of biotechnology productions in accordance with rules GMP; • to be able to define and optimize technological parameters of biotechnologies, to calculate, design, and simulate new technological schemes of biotechnology productions; • to know foundations of building design and specific requirements for canalization, water, electricity, ventilation, occupational health, and safety technique at microbiological enterprises. • to be able to use special professional knowledge and practical skills to solve specific problems in the field of biotechnology and bioengineering;
Required prior and related subjects: Prerequisites: Оrganization of biotechnical production (design and equipment); Mathematical modelling of microbiological processes; Regulatory support of biotechnology industry; Processes and equipment of biotechnology industry; Co-requisites: Modern application of biotechnological methods (industrial biotechnology); Modern application of biotechnological methods (biotechnology of food industries); Fulfilment of Master's qualification work
Summary of the subject: Execution of course project, preparation of explanatory note and graphical part. Preparation for the presentation and defense of the course project. Course project should be done in accordance with the requirements and principles of good manufacturing practice (GMP) and designed as a project document based on laboratory methods that involves the development or simulation of new technology and manufacture. Experimental-calculation research work which based on experimental research in the scientific group that includes: a review of literature data, processing of experimental data, experimental methods and results of mathematical calculations using computer programs, proposed technology.
Assessment methods and criteria: • content and correctness of calculations and drawings - 50 points, the use of modern references – 5 points, precision of execution - 5 points. • final control (defense of course project, test) – 40 points (oral form).
Recommended books: 1. Сидоров Ю.І., Влязло Р.Й., Новіков В.П. Процеси і апарати мікробіологічної та фармацевтичної промисловості: Навчальний посібник. – Львів: “Інтелект-Захід”, 2008. – 736с. 2. Кантере В. М., Мосичев М.С., Дорощенко М.И. и др. Основи проектирования предприятий микробьиологической промышленности. – М.: ВО «Агропромиздат», 1990, 304с. 3. Проектирование чистых помещений. Под ред. В. Уайт. Пер. с англ. – М.: изд «Клинкрум».- 2004 .- 360 с.