Cleanrooms may be different size from small to complex multilevel structures with large serviced equipment and utilities. Cleanroom is a controlled placement where different products are manufactured. And concentration of airborne particles is controlled to specified limits. So we need to control process of killing ultrafines airborne contaminants. The contaminations are generated by people, processes, facilities, and equipment. They must be continually removed from the air. The level of air cleanliness in the room must be regulated by standards. The most frequently used standard is the ISO 14644.
It is a document that establishes standard classes of air cleanliness in terms of airborne particulate levels in cleanrooms and clean zones. ” A room which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, e. g. temperature, humidity, and pressure, are controlled as necessary. ” /1/ The basic function of a cleanroom is to protect the manufactured product from contamination.
In the pharmaceutical production economical survival of the manufacturer depends on the safety of the finished product. So, it is needed to know a potential source of contamination, which could include the working environment itself. Requirements of the quality of supply air have increased due to development of new high technologies in different sectors of human activities. Main operation factors which characterize air quality are temperature, humidity, pressure, and cleanness. Settings are chosen on conditions to support every individual technological process.
Maximum requirements for air quality are concentration of suspension particles per unit of air capacity and maximum permissible quantity of viable microorganisms per unit of air capacity 2 Therefore, we can not use general ventilation systems in pharmaceutical cleanrooms for the permanent maintaining of these parameters. In this case we need systematic methods to create special engineering constructions. Cleanroom means a complex of technological tools for supporting set-up parameters of air quality. In this thesis I would like to analyze main applications and rules of cleanrooms in pharmaceutical industry.
My purpose is study how cleanrooms should be designed and how cleanrooms can be controlled. I also will compare Russian and International requirements of similar spaces. 2. CONTAMINATION SOURCES AND REGULATING STANDARDS 2. 1 Contamination sources There are several sources of contamination such as process equipment, personnel and surfaces. Bacteria are the most important contaminant in a pharmaceutical cleanroom. Almost all of these come from the people in the room. So we need to know the number of people who are working in the rooms.
As this will have a direct behavior on the quantity of air required to dilute and remove the airborne dispersion of contamination from their bodies. The efficiency of their cleanroom clothing will have an influence to the contamination dispersed by the people in the room and air quantity. Cooling load also depends on the type of clothing. The more effective the clothing is in preventing dispersion, the less exchange of air there is through the clothing fabric. Staff will feel discomfort due to high temperature and likely to require lower room temperatures.
Temperature level of cleanroom ordinary is 20°C with an RH of 40% ± 5%. For moisture sensitive materials it is required lower RH 25% ± 5%. Also these levels depend on geographical location, production and clothing worn. So dry bulb temperatures can vary in the range of 18°C to 22°C. /6/ Another significant source of particulate contamination is process equipment. Prevention by removal of particles at source should be the first objective before a 3 limitation is made for removing it once it has entered the cleanroom space. This will ensure a more cost-effective design.
Coming into the cleanroom an airborne contamination from outside is an ordinary problem. That can happen if outside airborne contamination produced by badly detailed material into the cleanroom. So holes in construction should be minimized. And the room became sealed to prevent this problem. The entering of contamination can also be provided when personnel, equipment or material are distributed through badly designed airlocks and changing areas. There can be surface or air contamination. Pharmaceutical cleanroom suites consist of different cleanrooms, where are made several steps of production.
Standards of environmental control increase step by step when product materials and packaging components are carried out processes into different rooms. It is continued until one reaches the moment of product filling, closing and sealing. There is required the highest quality condition. Less environmental conditions are required when a sealed product coming for labeling and inspection. Different standards of environmental control are reached by various air supply rates and the usage of unidirectional flow units or isolators at the critical areas.