Pharmaceutical clean room or clean area, refers to the need to control dust particles and microbial contamination of the region. In accordance with GMP design requirements, pharmaceutical production plant is usually divided into general production area (no clean requirements), control area (100000 level, 300000 level), clean area (10000 level) and aseptic area (100 level). Drugs are used to cure the sick to save people's lives, in order to ensure the quality and safety of drugs, GMP regulations, preparation production, raw materials fine baking bags, preparations used in the raw materials, packaging materials in direct contact with the drug, etc., should be carried out in the clean area. Therefore, the so-called clean room, first of all, the basic elimination of harmful gases, bacteria, microorganisms, particulate pollutants, etc., and secondly, the temperature, pressure, noise, light and other environmental factors (indicators) in the workshop should also be within a reasonable range.
(ii) pharmaceutical clean room clean area should meet what requirements?
The clean area through a large air conditioning system and air filtration facilities, so that a relatively closed environment to achieve the required cleanliness requirements, the formation of our need for "clean area".
1) temperature and humidity: should meet the temperature and humidity requirements of the production varieties.
2) the surface of the clean area: the surface of the clean area (walls, floors, ceilings) should be flat, smooth, no cracks, tight seams, no particles off, so as to avoid the accumulation of dust, to facilitate the effective cleaning, disinfection services should be carried out when necessary.
3) Cleanliness: Pharmaceutical factory clean area for ABCD, mainly the number of particles and microorganisms in the air, must meet the cleanliness requirements specified in the level.
4) personnel entering the clean area, must be required to change shoes, changing clothes, hand washing, disinfection of hands before entering the clean area.
(C) pharmaceutical clean room disinfection services
? Disinfection services is a pharmaceutical clean room to protect the quality of production of the key links. Vaporized hydrogen peroxide (VHP) disinfection decomposed into oxygen and water, no residual toxicity, is recognized as a highly efficient and environmentally friendly disinfection service method, Shanghai FANTON biological disinfection services research and development of vaporized hydrogen peroxide disinfection robot kino, easy to carry, easy to operate, one-button start disinfection, can be quickly and efficiently and flexibly used for disinfection of pharmaceutical factories, no dead ends, no residue, saving human resources, is a new Disinfection and sterilization equipment.
? Disinfection robot kino can be a one-time completion of the air, equipment and facilities surface disinfection services, disinfection process for a variety of bacteria (including Escherichia coli, green thick bacillus, staphylococcus), fungi, viruses have a very strong ability to kill, on the buds, molds and have a very good effect on the spores, to achieve the verified spores of the 6-log kill rate. Disinfection residue degradation generates water and oxygen, no residue and no pollution, no corrosion to equipment and facilities, good material compatibility. Shanghai FANTON Bio-disinfection Service has been engaged in disinfection service of pharmaceutical factories for decades, and is familiar with microbial contamination management scheme, high-tech disinfection robot equipment combined with air-conditioning pipeline system disinfection,? It can be used for pathogen disinfection service in the closed environment of GMP workshop to rebuild the effect of clean and sterile environment.