Laborator de Microbiologie [MicroLab]

mioara.alexandru@nipne.ro

Tel: 021.404.2369 / Fax: 021 457 4267

Cuvinte cheie: teste de sterilitate, testari biologice/microbiologice, identificare patogeni

  • Autorizat ANMDM
    04-07-2017

    ANMDM - Autorizatie de fabricatie, nr. 81 (2017)
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    Certificat ANMDM
    28-07-2017

    ANMDM - Certificat privind conformitatea cu buna practica de fabricatie, nr. 036 (2017)
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    Acreditat RENAR
    20-04-2018

    RENAR - Certificat de acreditare, nr. LI 1147 (2018)
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  • Laboratorul de Microbiologie din cadrul departamentului IRASM (MicroLab - IRASM) este un laborator independent de control al calitatii produselor farmaceutice si dispozitivelor medicale.

    Laboratorul de Microbiologie (MicroLab - IRASM) este autorizat de catre Agentia Nationala a Medicamentului si Dispozitivelor Medicale pentru efectuarea testelor de incarcatura microbiana, testelor de sterilitate si determinarea endotoxinelor bacteriene pentru produse farmaceutice si dispozitive medicale. De asemenea, laboratorul este acreditat de catre RENAR in conformitate cu standardul SR EN ISO 17025 pentru majoritatea testelor incluse in pachetul de servicii si are implementat si certificat sistemul de management al calitatii in acord cu standardul SR EN ISO 9001, SR EN ISO 13485 si SR EN ISO 11137.

    Suprafata totala a laboratorului este de 150 m2. Laboratorul este organizat astfel incat sa fie respectate normele europene referitoare la organizarea unui Laborator de Microbiologie, respectandu-se fluxurile de materiale si personal. Laboratorul cuprinde doua zone principale: zona climatizata si zona de camera curate. Sunt asigurate toate conditiile pentru a fi evitata contaminarea probelor, personalului sau mediului.

    Dispunand de dotari moderne, echipamente performante si personal competent, laboratorul ofera servicii de inalta calitate

    Teste microbiologice oferite:

    • Teste de incarcatura microbiana (pentru produse farmaceutice finite, materii prime si ambalaje farmaceutice, apa purificata, suplimente alimentare, cosmetice si dispozitive medicale de unica folosinta):
    - Determinare numar total de microorganisme aerobe
    - Determinare numar total de fungi (drojdii si mucegaiuri)
    - Identificare Escherichia coli
    - Identificare Pseudomonas aeruginosa
    - Identificare Staphylococcus aureus
    - Identificare Salmonella sp.
    - Identificare Candida albicans
    • Teste de sterilitate (pentru produse farmaceutice, ambalaje farmaceutice si dispozitive medicale de unica folosinta)
    • Teste pentru monitorizarea spatiului din zona de productie (control aeromicroflora, suprafete, amprenta operator)
    • Determinare endotoxine bacteriene (pentru produse farmaceutice si dispozitive medicale de unica folosinta)
    • Identificare Legionella sp. si L. pneumophila din probe de apa (metoda Polymerase Chain Reaction - PCR sau metoda cultivarii pe mediu de cultura)

    Testele sunt efectuate in conformitate cu documentul de referinta European Pharmacopoeia si cu standardele aplicabile in domeniu.

    MicroLab - IRASM participa permanent la scheme de intercomparare organizate la nivel european, verificand astfel calitatea testelor efectuate.

    Alaturi de Laboratorul de Dozimetrie din cadrul aceluiasi Departament, Laboratorul de Microbiologie poate oferi serviciul complet de validare a sterilizarii cu radiatii ionizante pentru dispozitive medicale, conform standardului SR EN ISO 11137.

    Personalul laboratorului este implicat, totodata, in activitati stiintifice derulate in cadrul proiectelor de cercetare, contribuind semnificativ la realizarea acestora prin testele microbiologice efectuate.

  • Radioresistance of biodegradation fungi and its importance in establishing the decontamination dose

    Laura Trandafir, Florina Lucica Zorila, Mioara Alexandru, Mihaela Ene, Mihai Constantin, Alexandru Alistar, Mihalis Cutrubinis, Ovidiu Iordache, Rodica Ioana Stanculescu

    ICAMS Proceedings (2014), 561-566

    Influence of some Trichoderma species on photosyntesis intensity and pigments in tomatoes

    Mioara Alexandru, Daniela Lazar, Mihaela Ene, Tatiana Eugenia Sesan

    Romanian Biotechnological Letters, Vol 18 (4) ( 2013): 8499-8510

    Establishing the irradiation dose for paper decontamination

    Ioan Valentin Moise, Marian Virgolici, Constantin Daniel Negut, Mihaela Manea, Mioara Alexandru, Laura Trandafir, Florina Lucica Zorila, Catalina Mihaela Talasman, Daniela Manea, Steluta Nisipeanu, Maria Haiducu, Zamfir Balan

    Radiation Physics and Chemistry, 81 (2012) 1045-1050

    Sterilization validation for medical devices at IRASM microbiological laboratory - Practical approaches

    Laura Trandafir, Mioara Alexandru, Mihai Constantin, Anca Ionita, Florina Zorila, Valentin Moise

    Radiation Physics and Chemistry 81(2012), 1513-1515

    Validation of testing protocol for pharmaceutical products with antimicrobial activity

    Laura Trandafir, Mihaela Ene, Mioara Alexandru, Mihai Constantin

    Innovative Romanian Food Biotechnology Volume 2, No.2 Issue of september 25, 2008 Pages 17-21

    Sterilization Validation for medical compresses at IRASM Multipurpose Irradiation Facility

    Mioara Alexandru, Mihaela Ene

    Radiation Physics and Chemistry 76 (2007), 1547 - 1550, Volume 7

    Class II acidic chitinase expression in tomatoes in late stages of infection with Trichoderma and arbuscular mycorrhizal fungi

    Mihaela Ene, Mioara Alexandru, Daniel C. Negut, Tatiana E. Sesan

    Romanian Biotechnological Letters, Vol 18 (5) ( 2013): 8645-8656

    Antioxidant and antibacterial properties of the extracts from Pleurotus ostreatus EVFB1 and EVFB4

    Emanuel Vamanu, Mihaela Ene, Adrian Vamanu, Diana Smarandache, Ionela Sarbu, Ovidiu Popa, Narcisa Babeanu, Sultana Nita, Barcari Veaceslav

    Romanian Biotechnological Letters, Vol. 16, No.1 (2011) Supplement, 40-46

    Antioxidant and Antimicrobial Properties of the Extracts from Pleurotus ostreatus M2191 and PQMZ91109

    Emanuel VAMANU, Mihaela ENE, Adrian VAMANU, Diana PELINESCU

    Bulletin UASVM Animal Science and Biotechnologies, 68(1-2), 2011

    Determination of Antioxidant and Antimicrobial Properties of Alcoholic Extract from Pleurotus ostreatus M2191 Mycelium Obtained in the Presence of Various Nitrogen Sources

    Emanuel Vamanu, Mihaela Ene, Diana Pelinescu, Ionela Sarbu, Adrian Vamanu, Sultana Nita

    REV. CHIM. (Bucharest),?62,?No. 12 (2011), 1189-1194

    Approaches to the study of mycorrhizas in Romania

    Tatiana Eugenia Sesan, F. Oancea, C. Toma, G.-M. Matei, S. Matei, F. Chira, D. Chira, E. Fodor, C. Mocan, M. Ene, M. Alexandru

    Symbiosis, Vol. 52, Number 2-3, 75-85, 2010

    Effect of gamma irradiation on plants in interaction with arbuscular mycorrhizae

    Ene Mihaela, Trandafir Laura Si Alexandru Mioara

    NUKLEONIKA - International Journal of Nuclear Reasearch (2009); vol. 54, No. 2, 89-92

    Magnetospirillum gryphiswaldense: fundamentals and application

    I. Ardelean, C. Moisescu, M. Ignat, M. Constantin, M. Virgolici

    Biotechnology & Biotechnological Equipment, Volume 23, Number 2, Pages 751-754 (2009)

    Magnetospirillum gryphiswaldense as a source of magnetite nanoparticles: biological and bionanotechnological significance

    C. Moisescu, M. Ignat, M. Constantin, M. Virgolici, M. Cirnu, I. Ardelean

    Proceedings of the International Symposium on New Researches in Biotechnology - Serie F (Special Volume) 2008, pg 593 - 601, U.S.A.M.V. Bucuresti

    Microscopical examination of plant reaction in case of infection with Trichoderma and Mycorrhizal fungi

    Mihaela Ene, Mioara Alexandru

    Romanian Biotechnological Letters, Volume 13, No.6, Pages13 - 19, 2008

Ultima actualizare: 27.07.2015