NEWS

Pharmacy

Quality of pharmaceutical production is put by technology and the manufacture organization, including the cleanliness of technological mediums. Since 2000 Miass Factory of Medical Equipment has carried out designing and construction of cleanrooms for different fields of industries. As the base for this direction of activity 10-years-old experience of our factory in creation of cleanrooms for medical units serves...

CLEANROOM

  • Air treatment, decontamination and distribution system;

  • Climate control system;

  • Cleanroom structure (structural elements providing leakproofness);

  • medical, technological and engineering equipment integrated with the cleanroom structure.

 

Licences
ÀÌÑ ÌÇÌÎ/English Version/Licences

Licenses

  1. License for production. ¹99-03-000950 valid from 27.12.07 till 27.12.12 ã.
  2. License for structural design (levels of responsibility I and II according to the State Standard) registered under ¹ ÃÑ-5-74-03-26-0-7415058730-007403-1 valid from 28.02.2008 till 30.07.2012.
  3. License for structures construction (levels of responsibility I and II according to the State Standard) registered under ¹ ÃÑ-5-74-03-27-0-7415058730-007402-1 valid from 28.02.2008 till 06.08.2012.

Certificates of Conformance

  1. Complex of equipment  for health-care rooms qualified as clean or specially clean Ê×Ï-01-"ÀÌÑ", registered under ¹ ÐÎÑÑ RU.ME55.H01906 valid from 24.04.2007 till 24.04.2010.
  2. Complexes of cleanrooms for electronic, food, medical, microbiologic and pharmacy industry Ê×Ï-ÌÇÌÎ registered under ¹ ÐÎÑÑ RU.ME55.H02112 valid from 15.02.2008 till 24.05.2010 ã.
  3. Air dispensers ÐÂ-ÀÌÑ: ÐÂ-11, ÐÂ-12, ÐÂ-22, ÐÂ-23, ÐÂ-24, ÐÂ-Í, ÐÂ-Ã, ÐÂ-Ó, ÐÂ-Ë with filters of G, F, H and U classes, registered under ¹ ÐÎÑÑ RU.ME55.Í02368 valid from 20.02.2009 till 20.02.2012.
  4. Illuminator built-in imprevious lumenescent registered under ¹ ÐÎÑÑ RU.ME55.Â02552 valid from 10.12.2009 till 10.12.2012.
  5. Metal sandwich panels with mineral wool filling for wallings, registered under ¹ ÐÎÑÑ RU.ÑË49.Í00273 valid from 30.12.2009 till 30.12.2012.
  6. Inactivation system ÓÈÍ-ÀÌÑ for complexes of cleanrooms registered under ¹ ÐÎÑÑ RU.ME55.H01962 valid from 28.06.2007 till 28.06.2010.
  7. Medical gases and power supply console ÊÏÌ-ÀÌÑ, registered under ¹ ÐÎÑÑ RU.ME55.H01981 valid from 26.07.2007 till 26.07.2010.
  8. Certificate of conformance of quality management system to the requirements of GOST R ISO 9001-2008 registered under ¹ÐÎÑÑ RU ÈÑ56.Ê00125 valid from 20.10.2009 till 19.05.2011.
  9. Bendageless unit for localized burns ÓÁË-001-ÀÌÑ
    ¹ ÐÎÑÑ RU.ME55.H02466 valid from 24.07.2009 till 24.07.2012 ã.

Fire Safety Certificates

  1. Metal sandwich panels for building envelops registered under ¹ ÑÑÏÁ.RU.ÎÏ013.Í.00644 valid from 23.10.2009 to 22.10.2012. (fire resistance)
  2. Plastic cladding wall and ceiling panels for building envelop ÎÏÏ-ÀÌÑ of cleanrooms registered under ¹ÑÑÏÁ.ÀÒ.ÎÏ013.Â.00414 valid from 06.03.2008 till 05.03.2010.
  3. Metal sandwich panels for building envelops registered under ¹ÑÑÏÁ.RU.ÎÏ013.H.00638 valid from 21.08.2009 till 20.08.2012 (burning quality)

Registration Certificates

  1. Registration Certificate for medical equipment unit.. Complex of equipment for health-care rooms qualified as clean or specially clean Ê×Ï-01-"ÀÌÑ", registered under ¹ 29/16030403/5242-03, valid from 29.04.2003 till 04.04.2013. Technical Conditions 9451-001-21504087-2003
  2. Registration Certificate for medical equipment unit. Air Cleaner ÁÎÂ-001-ÀÌÑ, registered under ¹ ÔÑ 022à2643/2954-06, valid from 14.03.2006 till 14.03.2011. Technical conditions 9451-001-21504087-2006.
  3. Registration Certificate for medical equipment unit. PCR-box, registered under ¹ ÔÑ 02012006/3661-06 valid from 27.06.2006 till 27.06.2011 Technical conditions 443-006-21504087-2006
  4. Registration Certificate for medical equipment unit. Medical gases and power supply console ÊÏÌ-ÀÌÑ registrated under ¹ ÔÑ 022à2006/4980-06 valid from 18.12.2006 till 18.12.2011. Technical Conditions 9452-005-21504087-2006

Sanitary and Epidemiological Reports

  1. Complexes for cleanrooms for electronic, food, medical, microbiologic and pharmacy industries and health-care rooms, registered under ¹ 74.50.06.528.Ï.000251.02.04 valid from 18.02.2004 till 28.02.2009.
  2. Clean and decontaminating unit ÁÎÂ-001-ÀÌÑ. (Variants: "Module", ËÁÎÇ - laminar boxes for operating rooms, ÀËÏ - aseptic laminar units, ÑËØ - sterile laminar box, unit "Pelican"), registered under ¹ 74.50.06.945.Ï.001651.10.04 valid from 20.10.2004 till 20.10.2009.
  3. Metal trilaminar panels for building envelop, registered under ¹ 74.04.03.528.Ï.000154.05.09 valid from 12.05.2009 till 12.05.2014.
  4. Cladding plastic wall and ceiling building envelop for cleanrooms (MAX type of plastic), registered under ¹ 74.50.03.570.Ï.001515.09.05 valid from 28.09.2005 till 28.09.2010 ã.
  5. Double-layer metal panels for building enveloping of cleanrooms, registered under ¹ 74.50.03.528.Ï.000153.02.08 valid from 04.02.2008 till 29.10.2010.
  6. Imprevious built-in luminescent illuminator for clinic areas, registered under ¹ 74.50.03.346.Ï.001517.09.05 valid from 28.09.2005 till 28.09.2010 ã.
  7. Air despenser with Í13 filter, registered under ¹ 74.50.03.945.Ï.001528.09.05 valid from 29.09.2005 till 29.09.2010.
  8. Doors and windows  registered under. ¹ 74.50.03.570.Ï.001516.09.05 valid from 28.09.2005 till 28.09.2010.
  9. Product's production and implementation registered under ¹ 74.04.03.000.Ì.000250.09.05 valid from 19.09.2005 till 19.09.2010 ã.
  10. Cladding plastic wall and ceiling panels for cleanrooms(Manminit plastic), registered under ¹ 74.50.03.570.Ï.000685.05.07 valid from 22.05.2007 till 21.05.2012.

Other Certificates

  1. Certificate of Analytical Laboratory (Center) Accredetation, registered under ¹ ÐÎÑÑ RU.0001.513956 valid from 21.05.2008 till 03.04.2013.
  2. Supplement: The Scope of accreditation

Licensing documents valid in Belarus Republic

  1. Registration certificate ¹ÈÌ-7.5572.
    Air Cleaner "ÁÎÂ-001-ÀÌÑ" registers under ¹ Ìò-7.1726/7.002-0501, valid from 22.04.2005 till 22.04.2010.
  2. Certificate ¹08-33-0.267610.Metal sandwich panels with mineral wool filling for walling registered under ¹Ñò-0.19998-0506, valid from 29.06.2005 till 29.06.2006.
  3. Certificate ¹08-33-0.275675.Metal duplex panels with filling for cleanrooms walling, registered under ¹ Cò-0.19998/002-0511, valid from 11.11.2005 till 11.11.2006.
  4. Certificate ¹08-33-0.275287. Lining plastic wall and ceiling panels for clean rooms, registered under ¹ Ñò-0.20245-0511, valid from 15.03.2006 till 15.03.2009.

Licensing documents valid in Kazakhstan Republic

  1. Registration certificate ÐÊ-ÌÒ-5¹005776. Complex of equipment for health-care instituts,qualified as clean or specially clean Ê×Ï-01-"ÀÌÑ", valid from 14.01.2009 till 14.01.2014. Supplement

  2. State license ÃÑ˹ 0004070 valid from 08.04.2009 till 08.04.2014.
    3. Supplement

Letters of certification authorities (ÎÑ) and control board (ÎÍ) about non-mandatory certification and  Sanitary and Epidemiological Reports

  1. PCR-boxes.
  2. Clean and decontaminating units ÁÎÂ-001-ÀÌÑ ((Variants: "Module", ËÁÎÇ - laminar boxes for operating rooms, ÀËÏ - aseptic laminar units, ÑËØ - sterile laminar box, unit "Pelican").
    ÓBandageless treatment unit  ÓÁË-001-ÀÌÑ.
    Registrated under.¹ ÌÅ55.ÑÏ.1998 valid from 17.01.2007.
  3. Medical gases and power supply consoles ÊÏÌ-ÀÌÑ.
    Registrated under Î͹01/2615-8-31 valid from 24.03.2008.
  4. Complexes of cleanrooms Ê×Ï-"ÀÌÑ"
    Registrated under ÎÍ ¹01/14760-8-31 valid from 10.12.2008.
  5. Complexes of cleanrooms Ê×Ï-"ÌÇÌÎ"
    Registrated under ÎÍ ¹05/36-1-2513-09 valid from 30.03.2009.

Diplomas

  1. "Unit of design organizations of South Ural", registered under ¹ 74-01-09-Ï valid from 30.06.2009.
  2. "Unit of building companies of South Ural", registered under ¹ 74-254-09 valid from 03.06.2009.
  3. "Diploma of permit to work that influence to the safetiness of capital structures" , registered under ¹ CPO-C-030-0009-7415058730-2009 valid from 08.10.2009.

Patents

Patent for useful model ¹85612 Air ingress unit with cleaning system valid from 10.08.2009 till 20.04.2019.
Patent for useful model ¹87938 Fume hood valid from 27.10.2009 till 24.03.2019.
 
   
Russia, Chelyabinsk region, Miass, Turgoyak highway, 2/16, ph./fax: +7 (3513) 24-25-46