Regulatory Framework Experimental Biological Clinics (Vivaries) And Nursery For Laboratory Animals

E. Bondareva(1), M. Makarova(2), M. Kovaleva(3), S. Khodko(2), V. Makarov(1) 1-Institute of pre-clinical studies 188663, Leningradskiy region, Vsevolozhskiy district, Kuzmolovskiy, 3, Zavodskaya st., b. 245, Russia; 2-Scientific-Production Organization «Houm оf Pharmacy» 188663, Leningradskiy region, Vsevolozhskiy district, Kuzmolovskiy, 3, Zavodskaya st., b. 245, Russia; 3-St. Petersburg Institute of Pharmacy, 188663, Leningradskiy region, Vsevolozhskiy district, Kuzmolovskiy, 3, Zavodskaya st., b. 245, Russia Е-mail: bondareva.ed@doclinika.ru

Abstract

Summary. The test center is a business entity and in its activities it should be guided by national regulatory documents. Speaking about separate structural divisions, such as a nursery and a vivarium, it is necessary to consider not only national, but also international ND and other manuals. Medical and biological research and obtaining adequate undistorted results require a specially equipped vivarium, trained personnel, and specialized programs for the care of laboratory animals. In premises for keeping animals, proper parameters of temperature, humidity, air exchange and illumination should be observed in accordance with the requirements of regulatory documents. Microclimate parameters have a significant impact on the state and life processes of animals, which directly affects the conduct of experimental studies and obtaining reliable data. Proper maintenance and use of laboratory animals for preclinical studies will allow for a higher quality of the animals themselves and, as a result, obtaining more reliable research results. An organization that conducts preclinical research cannot focus only on Federal Law No. 61 «On the Circulation of Medicinal Products» and on GOST 33044-2014 Principles of Good Laboratory Practice. The activity of such an object as a vivarium or nursery of laboratory animals is a complex set of activities. In such a complex should be considered: Protection of personnel and labor protection associated with the accumulation of hazardous substances in the air of the working area (ammonia, formalin, wool and dust from animals, etc.), with the risk of occurrence and spread of epizootic diseases; Ensuring the well-being and health of laboratory animals in order to respect not only the purity of the experiment, but also ethical principles; The inevitability of the generation of hazardous waste (medical waste and biological waste, plums of chemicals from research laboratories, waste of medicines, etc.); The proper handling of drugs. This article provides a brief overview of the national and international regulatory documents governing the vivarium, taking into account all the most important elements that require control at the legislative level.

References

  1. Federal`nyy zakon №52-FZ ot 30 marta 1999 g. «O sanitarno-e`pidemiologicheskom blagopoluchii naseleniya».
  2. Federal`nyy zakon № 9-FZ ot 24 iyunya 1998 g. «Ob othodah proizvodstva i potrebleniya».
  3. Federal`nyy zakon №61-FZ ot 12 aprelya 2010 g. «Ob obrashhenii lekarstvennyh sredstv».
  4. Federal`nyy zakon №7-FZ ot 10 yanvarya 2002 g. «Ob ohrane okruzhayushhey sredy».
  5. Federal`nyy zakon №243-FZ ot 13 iyulya 2015 g. «O veterinarii».
  6. Syryh V.M. Teoriya gosudarstva i prava: uchebnik. M.: Yusticinform. 2012: 704.
  7. Minina E.L. Sistema agrarnogo zakonodatel`stva i osnovnye tendencii ego razvitiya. Zhurnal rossiyskogo prava. 2010. 6: 162 c.
  8. Mohov A.A., Murashev A.N., Krasil`shhikova M.S., Hohlova O.N. i dr. O neobhodimosti sovershenstvovaniya zakonodatel`stva v sfere ispol`zovaniya laboratornyh zhivotnyh. Vedomosti Nauchnogo centra e`kspertizy sredstv medicinskogo primeneniya. 2016. 4: 62–8.
  9. Postanovlenie Pravitel`stva Rossiyskoy Federacii №554 ot 24.07.2000 «Ob utverzhdenii Polozheniya o gosudarstvennoy sanitarno-e`pidemiologicheskoy sluzhbe Rossiyskoy Federacii i Polozheniya o gosudarstvennom sanitarno-e`pidemiologicheskom normirovanii».
  10. SP (Sanitarnye pravila) №2.2.1.3218-14 ot 29 avgusta 2014 g. «Sanitarno-e`pidemiologicheskie trebovaniya k ustroystvu, oborudovaniyu i soderzhaniyu e`ksperimental`no-biologicheskih klinik (vivariev)».
  11. Vasilevich F. I., Vasilevskiy N. M., Shevkoplyas V. N. Garmonizaciya veterinarnogo zakonodatel`stva. Uchenye zapiski Kazanskoy gosudarstvennoy akademii veterinarnoy mediciny im. NE` Baumana. 2013: 214.
  12. RD-APK №3.10.07.02-09 ot 01 dekabrya 2009 g. «Metodicheskie rekomendacii po soderzhaniyu laboratornyh zhivotnyh v vivariyah nauchno-issledovatel`skih institutov i uchebnyh zavedeniy».
  13. GOST №33215-2014 ot 09 noyabrya 2015 g. «Rukovodstvo po soderzhaniyu i uhodu za laboratornymi zhivotnymi. Pravila oborudovaniya pomeshheniy i organizacii procedur».
  14. Selezneva A. I., Glembockiy S.V., Polyakov S.V., M.N. Makarova, V.G. Makarov i dr. Analiticheskiy obzor normativnoy bazy dlya obespecheniya nadlezhashhego kachestva doklinicheskih issledovaniy v Rossii. Razrabotka i registraciya lekarstvennyh sredstv. 2017. 2 (19): 252–9.
  15. SanPiN №2.1.6.1032-01 ot 17 maya 2001 g. «Gigienicheskie trebovaniya k obespecheniyu kachestva atmosfernogo vozduha naselennyh mest».
  16. PDK №5158-89 ot 24 noyabrya 1989 g. «Predel`no dopustimye koncentracii zagryaznyayushhih veshhestv v atmosfernom vozduhe naselennyh mest».
  17. SanPiN №2.1.3.2630-10 ot 18 maya 2010 g. «Sanitarno-e`pidemiologicheskie trebovaniya k organizaciyam, osushhestvlyayushhim medicinskuyu deyatel`nost`».
  18. GOST №33215-2014 ot 09 noyabrya 2015 g. «Rukovodstvo po soderzhaniyu i uhodu za laboratornymi zhivotnymi. Pravila oborudovaniya pomeshheniy i organizacii procedur».
  19. GOST №33216-2014 ot 09 noyabrya 2015 g. «Rukovodstvo po soderzhaniyu i uhodu za laboratornymi zhivotnymi. Pravila soderzhaniya i uhoda za laboratornymi gryzunami i krolikami».
  20. GOST №33217-2014 ot 09 noyabrya 2015 g. «Rukovodstvo po soderzhaniyu i uhodu za laboratornymi zhivotnymi. Pravila soderzhaniya i uhoda za laboratornymi hishhnymi mlekopitayushhimi».
  21. GOST №33218-2014 ot 09 noyabrya 2015 g. «Rukovodstvo po soderzhaniyu i uhodu za laboratornymi zhivotnymi. Pravila soderzhaniya i uhoda za nechelovekoobraznymi primatami».
  22. GOST №33219-2014 ot 09 noyabrya 2015 g. «Rukovodstvo po soderzhaniyu i uhodu za laboratornymi zhivotnymi. Pravila soderzhaniya i uhoda za rybami, amfibiyami i reptiliyami».
  23. Islamov R. A. Organizaciya monitoringa zdorov`ya laboratornyh zhivotnyh. Vestnik Kazahskogo nacional`nogo medicinskogo universiteta. 2016; 3: 174–8.
  24. FELASA working group on revision of guidelines for health monitoring of rodents and rabbits et al. FELASA recommendations for the health monitoring of mouse, rat, hamster, guinea pig and rabbit colonies in breeding and experimental units. Laboratory animals. 2014. Vol. 48 (3): 178–92.
  25. Murashev A. N., Popov V.S., Krasil`shhikova M.S., Zharmuhamedova T.Yu. i dr. Nacional`nye osobennosti doklinicheskih issledovaniy i ispol`zovaniya laboratornyh zhivotnyh v Rossii: problemy i perspektivy. Vedomosti Nauchnogo centra e`kspertizy sredstv medicinskogo primeneniya. 2015. 2: 35–9.
  26. Baker D. G. Natural pathogens of laboratory animals: their effects on research. Society for Microbiology (ASM). 2003: 385.
  27. SP (Sanitarnye pravila) №3.5.1378-03 ot 09 iyunya 2003 g. «Sanitarno-e`pidemiologicheskie trebovaniya k organizacii i osushhestvleniyu dezinfekcionnoy deyatel`nosti».
  28. Prikaz Minzdravsocrazvitiya Rossii №302n ot 12 aprelya 2011 g. «Ob utverzhdenii perechney vrednyh i (ili) opasnyh proizvodstvennyh faktorov i rabot, pri vypolnenii kotoryh provodyatsya predvaritel`nye i periodicheskie medicinskie osmotry (obsledovaniya), i Poryadka provedeniya predvaritel`nyh i periodicheskih medicinskih osmotrov (obsledovaniy) rabotnikov, zanyatyh na tyazhelyh rabotah i na rabotah s vrednymi i (ili) opasnymi usloviyami truda».
  29. Prikaz Minzdrava Rossii №125n ot 21 marta 2014 g. «Ob utverzhdenii Nacional`nogo kalendarya profilakticheskih privivok i kalendarya profilakticheskih privivok po e`pidemicheskim pokazaniyam».
  30. SP (Sanitarnye pravila) №1.3.3118-13 ot 28 noyabrya 2013 g. «Bezopasnost` raboty s mikroorganizmami I–II grupp patogennosti (opasnosti)».
  31. SP (Sanitarnye pravila) №1.3.2322-08 ot 28 yanvarya 2008 g. «Bezopasnost` raboty s mikroorganizmami III–IV grupp patogennosti (opasnosti) i vozbuditelyami parazitarnyh bolezney».
  32. SP (Sanitarnye pravila) №1.2.1318-03 ot 30 aprelya 2003 g. «Poryadok vydachi sanitarno-e`pidemiologicheskogo zaklyucheniya o vozmozhnosti provedeniya rabot s vozbuditelyami infekcionnyh zabolevaniy cheloveka I–IV grupp patogennosti (opasnosti), genno-inzhenerno-modificirovannymi mikroorganizmami, yadami biologicheskogo proishozhdeniya i gel`mintami».
  33. World Health Organization. Laboratory biosafety manual. World Health Organization. 2004.
  34. Chosewood L. C., Wilson D. E. Biosafety in microbiological and biomedical laboratories. 1999.
  35. SanPiN №2.2.4.548-96 ot 01 oktyabrya 1996 g. «Gigienicheskie trebovaniya k mikroklimatu proizvodstvennyh pomeshheniy».
  36. GOST №12.1.005-88 ot 29 sentyabrya 1988 g. «Sistema standartov bezopasnosti truda (SSBT). Obshhie sanitarno-gigienicheskie trebovaniya k vozduhu rabochey zony».
  37. SanPiN №2.1.7.2790-10 ot 09 dekabrya 2010 g. «Sanitarno-e`pidemiologicheskie trebovaniya k obrashheniyu s medicinskimi othodami».
  38. Veterinarno-sanitarnye pravila Glavnogo gosudarstvennogo veterinarnogo inspektora Rossiyskoy Federacii №13-7-2/469 ot 04 dekabrya 1995 g. «Veterinarno-sanitarnye pravila sbora, utilizacii i unichtozheniya biologicheskih othodov»

DOI

10.29296/2618723X-2018-04-08

Keywords

regulatory documents
vivarium
nursery
laboratory animals
good maintenance of animals

For citation

Bondareva E., Makarova M., Kovaleva M., Khodko S., Makarov V. Regulatory Framework Experimental Biological Clinics (Vivaries) And Nursery For Laboratory Animals. Laboratory Animals for Science. 2018; 4. https://doi.org/10.29296/2618723X-2018-04-08

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