«Association  of  Engineers  for  microcontamination  control»  (ASENMCO)
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ASENMCO develops standards on Clean Technologies and GMP rules.

The main goal is to comply with international norms and to eliminate technical barriers in trade. It meets the interests of industry, customers and country.

ASENMCO conducts two national Technical Committees for standardization:

  • TC 184 «Industrial Cleanliness»,
  • TC 458 «Manufacturing and Quality Control of Medicinal products».

These Technical Committees develop standards itself and translate ISO and EN standards to be approved as Russian national standards, making all necessary work.

ASENMCO represents Russia in ISO/TC 209 «Cleanrooms and associated controlled environments».

The main topics for standardization are as follows:

  • Cleanrooms;
  • General ventilation and air filters;
  • Clean compressed air;
  • GMP Rules and standards for pharmaceutical industry in general;
  • Air cleanliness in hospitals.

Abbreviations:

  • GOST R ISO is the ISO standard that was translated into Russian and approved as Russian national standard;
  • GOST ISO is the ISO standard that was translated into Russian and approved as standard of EASC – Euro-Asian Council for Standardization, Metrology and Certification, that joins Bodies for Standardization of most Russian speaking countries;
  • GOST R EN is the European standard that was translated into Russian and approved as Russian national standard;
  • GOST R is the Russian national standard that was prepared by Russian institutions or individuals.

The only exception from this rule is abbreviation of GOST R 52249 «Manufacturing and quality control of medicinal products», that is direct translation of GMP EC Guideline into Russian.

Cleanrooms


  1. GOST ISO 14644-1-2002 Cleanrooms and associated controlled environments. – Part 1: Classification of Air Cleanliness
  2. GOST R ISO 14644-2-2001 Cleanrooms and associated controlled environments. – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-2000
  3. GOST R ISO 14644-3-2007 Cleanrooms and associated controlled environments. – Part 3: Test methods
  4. GOST R ISO 14644-4-2002 Cleanrooms and associated controlled environments. – Part 4: Design, Construction and Start-up
  5. GOST R ISO 14644-5-2005 Cleanrooms and associated controlled environments. – Part 5: Operations
  6. GOST R ISO 14644-6 Cleanrooms and associated controlled environments. – Part 6: Vocabular (at the approval stage);
  7. GOST R ISO 14644-7-2007 Cleanrooms and associated controlled environments. – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments);
  8. GOST R ISO 14644-8-2008 Cleanrooms and associated controlled environments. – Part 8: Classification of airborne molecular contamination (at the approval stage);
  9. GOST R ISO 14698-1-2005 Cleanrooms and associated controlled environments. Biocontamination control – Part 1: General principles and methods;
  10. GOST R ISO 14698-2-2005 Cleanrooms and associated controlled environments. Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data;
  11. GOST R 52538-2006 Cleanrooms. Technological garments. General requirements


General ventilation and air filters


  1. GOST R EN 779-2007 Particulate air filters for general ventilation
  2. GOST R EN 13779-2007 Ventilation for non-residential buildings – Performance for ventilation and room-conditioning systems
  3. GOST R 51251-99 Air filters. Classification .Marking.


GMP Rules and other standards for pharmaceutical industry

The main result of our work is approving GMP EC as Russian national standard as direct translation.
It took many years to convince authorities to do it and not to develop something GMP-like that differs from international practice.
The paper «GMP in Russia» describes the history of GMP in the country. Alexander Fedotov presented this paper in Tampere and Milan (2006).

For the first time GMP EC were approved in Russia in 2004 as GOST R 52249-2004.
By 2009 some changes and amendments to GMP EC were made.
The new version GOST R 52249-2009 was approved in May 2009.

  1. GOST R 52249-2004 Good Manufacturing Practice for Medicinal Products (GMP EC);
  2. GOST R 52537-2006 Manufacturing of medicinal products. Quality assurance system. General requirements;
  3. GOST R 52550-2006 Manufacturing of medicinal products. Organizing and technological documentation;
  4. GOST R 52896-2007 Manufacturing of medicinal products. Processing equipment for manufacturing of solid dosage forms. General requirements
  5. GOST R ISO 13408-1-2000 Aseptic processing of healthcare products – Part 1: General requirements
  6. GOST R ISO 13408-2-2007 Aseptic processing of healthcare products – Part 2: General requirements
  7. GOST R ISO 13408-6 Aseptic processing of healthcare products – Part 6: Isolators systems (at the approval stage);
  8. GOST R ISO 11138-1-2000 Sterilization of health care products – Biological indicators. – Part 1: General;
  9. GOST R ISO 11138-2-2000 Sterilization of health care products – Biological indicators. – Part 2: Biological indicators for ethylene oxide sterilization;
  10. GOST R ISO 11138-3-2000 Sterilization of health care products – Biological indicators. – Part 3: Biological indicators for moist heat sterilization;
  11. GOST R ISO 11140-1-2000 Sterilization of health care products – Chemical indicators. – Part 1: General Requirements
  12. GOST R ISO 11134-2000 Sterilization of health care products – Requirements for validation and routine control – Industrial moist heat sterilization;
  13. GOST R ISO 13683-2000 Sterilization of health care products – Requirements for validation and routine control of moist heat sterilization in healthcare facilities;
  14. GOST R ISO 11135-2000 Medical devices – Validation and routine control of ethylene oxide sterilization;
  15. GOST R ISO 11137-2000 Medical devices – Validation and routine control – Radiation sterilization;
  16. GOST R ISO 11737-1-2000 Sterilization of Medical devices – Microbiological methods – Part 1: Estimation of population of microorganisms on products;
  17. GOST R ISO 11737-2-2003 Sterilization of Medical devices – Microbiological methods – Part 2: Tests for sterility performed in the validation of sterilization process;
  18. GOST R 14160-2003 Sterilization of single-use medical devices incorporating materials of animal origin – Validation and routine control of sterilization by liquid sterilants;
  19. GOST R ISO 15378 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (at the approval stage);
  20. GOST R EN 12296 Biotechnology – Equipment – Guidance on testing procedures for cleanability (at the approval stage).


Air cleanliness in hospitals


    GOST R 52539-2006 Air cleanliness in hospitals. General requirements.


Clean compressed air


  1. GOST R ISO 8573-1-2005 Compressed air – Part 1: Contaminants and purity classes;
  2. GOST R ISO 8573-2-2005 Compressed air – Part 2: Test methods for aerosol oil content;
  3. GOST ISO 8573-3-2006 Compressed air – Part 3: Test methods for measurement of humidity;
  4. GOST R ISO 8573-4-2005 Compressed air – Part 4: Test methods for solid particle content;
  5. GOST ISO 8573-5-2006 Compressed air – Part 5: Test methods for oil vapour and organic solvent content;
  6. GOST R ISO 8573-6-2005 Compressed air – Part 6: Test methods for gaseous contaminant content;
  7. GOST R ISO 8573-7-2005 Compressed air – Part 7: Test method for viable microbiological contamination content;
  8. GOST R ISO 8573-8-2006 Compressed air – Part 8: Test methods for solid particle content by mass concentration;
  9. GOST R ISO 8573-9-2007 Compressed air – Part 9: Test methods for liquid water content.
 127299,  Russia,  Moscow,  K. Tsetkin str.,  4,  office 219, «АСИНКОМ»
Tel/fax:  +7(495)777-72-31,   +7(495)787-03-12
WWW (English):  www.asenmco.info   WWW (Russian):  www.asincom-group.ru|www.asincom.info|E-mail:  mail@asincom.info