Pharmacy

Pharmacy

Quality of pharmaceutical production is put by technology and the manufacture organization, including the cleanliness of technological mediums.
The basic sources of micropollution at pharmacy producing are personnel, equipment, in-coming air, raw materials, auxiliary material.
Using in pharmacy maintenance quality monitoring methods of ready product are selective, so that there is a poor quality risk in any pharmacy product. For the purpose of decrease in this risk, application of new technologies, guarantee providing release of qualitative production is necessary.
One of the most important elements of correct construction of technologic medium is cleanrooms where the most important technological researches of reception medical products are done.

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.
Complexes of cleanrooms for pharmacies meet all standard documents requirements. All activity in creation of cleanrooms for pharmacy, electronic engineering, medicine, micro biological and food-processing industry is licensed.
Creation of cleanrooms by our factory is based on complex approach, including validation on the different stages of manufacture.

The most important features of cleanrooms:

1. At architecturally-building decisions and internal furnish of premises: 
   • Operation of construction principle “premise in premise”;
     
   • Application of rational arrangement of aperture, passes of ventilation lines and electrical communications, heating systems, water supply and water drain;
     
   • Application of special construction of impervious hygienic wall and ceiling protections, which:
     
     • Have the smooth internal surfaces, easy accessible for washing and disinfection;
     • Have impervious and issued by profile of the rounded off form joints between walls, floor, ceiling;
       
     • Are made of the fire-resistant and nontoxic materials, steady against influence of disinfectant and UV-irradiation.
       
   • Application of antistatic linoleum for floor covering.
2. At technological decisions:
   • Application of rational technological and hardware schemes;
   • Exception of mutual crossing of personnel transits, “pure” and “dirty” technological streams, that is provided by lay-out of cleanrooms;
     
   • Zoning of premises groups to classes with identical degree of cleanliness;
     
   • Input maintenance in cleanrooms through air sluices;
   • Transfer of cargoes through material sluices and pass-through windows.
3. At heating, ventilation, micro climate and air environment of premises: 
   • Application of productivity of ventilation systems in accordance with premises classes of cleanliness and thermal loading, application of power saving up operating modes of systems, including application 30 % of stand by mode out of hours;
     
   • Highly effective three-stage clearing (terminal filters H13-H14) and bactericidal irradiation of in-coming air;
     
   • Air-conditioning and humidifying of submitted air;
   • Air delivery with organization of direct flowing, heedful of premise specification, generally by descending principle;
     
   • Rational organization of overflows of purer air and pressure drop between premises, allowing optimally use air environment opportunities and guarantee avoid air overflow from less pure zones to purer ones;
     
   • Monitoring and scheduling of the main climate parameters in cleanrooms.
     
4. At illuminating:
   • Application of the tight fixtures, capable to maintain sanitary processing by disinfectiants; 
   • Application UV-irradiation lamps for air disinfecting. 

Classification of cleanrooms for pharmacy is carried out under as much as possible admissible maintenance in premise air of the suspended particulate matter and of as much as possible admissible quality of viable microorganisms according to OST 42-510-98.