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Načrtovanje strategij za vzpostavitev dobre laboratorijske prakse za delo z gensko spremenjenimi organizmi II. varnostnega razreda v pogojih in vitro
ID Friedl, Fendi (Author), ID Karas Kuželički, Nataša (Mentor) More about this mentor... This link opens in a new window, ID Kandušer, Maša (Co-mentor)

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Abstract
Gensko spremenjeni organizem (GSO) je organizem, z izjemo človeka, ali mikroorganizem, katerega genski material je spremenjen s postopki, ki spreminjajo genski material drugače, kot to poteka v naravnih razmerah. Lahko je potencialno nevaren, toksičen, ali ima možnost nenadzorovanega širjenja. GSO razvrščamo v štiri varnostne razrede (VR). Uvrstitev v posamezni razred določa kombinacijo različnih ukrepov, smernic, ureditve laboratorijskih prostorov, varnostne in druge laboratorijske opreme, ki zagotavlja, da bo delo v zaprtem sistemu z GSO varno. V drugi VR , ki je v središču našega interesa, sodijo GSO, kateri povzročajo majhno tveganje za ljudi in okolje. Namen magistrskega dela je bil oblikovati strategije za vzpostavitev dobre laboratorijske prakse za delo z GSO VR2 v pogojih in vitro. Ugotovili smo, da je za zagon takšnega zaprtega sistema v Republiki Sloveniji (RS) potrebno izpolniti pogoje, ki jih določa zakonodaja s tega področja. Pogoji so naslednji: delovne površine zaprtega sistema morajo biti enostavne za čiščenje in odporne na vodo, kisline, baze, topila, razkužila in sredstva za dekontaminacijo. V stavbi, v kateri se nahaja zaprti sistem, mora biti avtoklav. Dostop do zaprtega sistema mora biti omejen, na vratih pa mora biti oznaka za biološko nevarnost. Obvezna je vzpostavitev posebnih ukrepov za nadzor nad razširjanjem aerosolov. Obvezna je uporaba zaščitne obleke. Zaradi obveznega preprečevanja širjenja GSO v okolje je dostop do laboratorija potrebno preprečiti vektorjem, kot so žuželke in glodavci. Obvezna je inaktivacija GSO v vseh materialih in odpadkih, ki so prišli v stik z GSO. Ker je za nemoteno delovanje zaprtega sistema odgovoren tudi razpored opreme znotraj prostora, smo v magistrsko delo vključili tudi predloge različnih postavitev laboratorijske opreme v prostoru, ki je na razpolago za vzpostavitev zaprtega sistema za delo z GSO VR2 na Fakulteti za farmacijo Univerze v Ljubljani (FFA UL). Primerjali smo priporočila različnih avtorjev s področja urejanja celičnih laboratorijev, predstavili več različic postavitve opreme in izrisali tloris najprimernejše. Poleg tega smo upoštevali tudi organizacijske ukrepe, ki jih predpisuje Zakon o ravnanju z gensko spremenjenimi organizmi (ZRGSO-UPB1), in določili pomen implementacije dobre mikrobiološke prakse k preprečevanju kontaminacije znotraj zaprtega sistema. Dobra mikrobiološka praksa dopolnjuje zadrževalne ukrepe, postopke in procese, katerih namen je ohraniti varnost tako znotraj kot tudi zunaj zaprtega sistema.

Language:Slovenian
Keywords:gensko spremenjeni organizem, varnostni razred, zaprti sistem, kontaminacija, zadrževalni ukrepi
Work type:Master's thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2021
PID:20.500.12556/RUL-126931 This link opens in a new window
Publication date in RUL:11.05.2021
Views:711
Downloads:105
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Secondary language

Language:English
Title:Planning strategies to establish good laboratory practice for working with biosafety level II genetically modified organisms in vitro
Abstract:
A genetically modfied organism, with the exception of a human being, is an organism or micro-organism whose genetic material is altered by processes that alter the genetic material differently than it occurs in nature. They can be potentially dangerous, toxic, or have the potential for uncontrolled spreading. There are four possible biosafety levels into which we classify them. Each level determines a combination of different measures, guidelines, layout of laboratory space, safety and other laboratory equipment that must be satisfied in order for work safely in a laboratory for genetically modfied organisms. Biosafety level II, which is the focus of our interest, includes genetically modfied organisms that pose little risk to humans and the environment. The purpose of the master's thesis was to plan strategies to establish good laboratory practice for working with biosafety level II genetically modfied organisms in vitro. We have came to conclusion that, in order to start such laboratory in the Republic of Slovenia, it is necessary to follow the conditions regulated by the law and legislation from this field. The conditions are as follows: the working surfaces of the laboratory must be easy to clean and resistant to water, acids, bases, solvents, disinfectabts and decontaminants. There must be an autoclave in the building where the laboratory is located. Access to the closed system must be restricted, with a biohazard sign on the door. It is mandatory to establish special measures to control the spread of aerosols. Protective clothing is required. It is mandatory to prevent contact of vectors such as insects and rodents with laboratory. Inactivation of genetically modfied organisms is mandatory in all materials and wastes that are genetically modfied organisms or have come into contact with them. Since the layout of the equipment inside the laboratory space is also responsible for the smooth operation of the laboratory system itself, we decided to include that part in this master's thesis. We decided to develop various layouts of laboratory equipment in the room available for the laboratory for work with biosafety level II genetically modfied organisms in the Faculty of pharmacy in Ljubljana. We compared the instructions of various authors in the field of arranging cell laboratories, and finally made our own floor plan. Among other things, we found how the implementation of good microbiological practice contributes to the prevention of contamination within the laboratory. Good microbiological practice complements containment measures, procedures and processes designed to maintain safety both inside and outside of the laboratory.

Keywords:genetically modified organisms, biosafety level, laboratory, contamination, containment measures

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