Simulation and Scaling of Biotechnological Production in the GMP System

Major: Biotechnology and Bioengineering
Code of subject: 7.162.03.O.002
Credits: 8.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Assistant, Ph.D., Natalija Monka
Semester: 1 семестр
Mode of study: денна
Learning outcomes: • to know regulatory documents and rules of microbiological processe modelling in accordance with international requirements and principles of good manufacturing practice (GMP) of biotechnological productions; • to know the principles of design, organization of design work and overall technology of cleanroom design for biotech enterprises and foundations of technological organizing of production; • to know 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.
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 biotechnological 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: General information about the aim, methods and design process. International standards for the clean room design. Optimization and scaling of cultivation. Clean room design for the biopharmaceutical industry. Clean rooms. Protective means from contaminants in the biotechnology industry. Space-planning and constructive solutions for industrial buildings. The concept of production infrastructure design.
Assessment methods and criteria: • frontal oral questioning, calculation (calculation-graphic) work – 20 points; • final control (exam) – 80 points (written-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.Чистые помещения. Под ред. И. Хаякавы. Перевод с японского В.Ю. Акифьева, Л.Н. Дмитрука и М.Е. Панюкова под ред. В.Г. Ржанова и В.И. Ушакова. Москва, Мир, 1990, 454 с. Cтр. 294. 4. Проектирование чистых помещений. Под ред. В. Уайт. Пер. с англ. – М.: изд «Клинкрум».- 2004 .- 360 с.