Design of purification system in pharmaceutical clean workshop
Design of purification system in pharmaceutical clean workshop
General principles of pharmaceutical clean workshop design: reasonable layout; strict division of areas; prevention of cross-contamination; convenient production operations. In order to achieve the purpose, the air purification measures generally taken mainly include: air filtration, the use of filters to effectively control the whole...
Text label: pharmaceutical clean workshop, pharmaceutical clean pharmaceutical cleanroom, clean workshop design
Design of purification system for pharmaceutical clean workshop
General principles of pharmaceutical clean pharmaceutical cleanroom design: reasonable layout; strict division of areas; prevention of cross-contamination; convenient production operations. In order to achieve the purpose, the air purification measures generally adopted mainly include: air filtration, using filters to effectively control the cleanliness of all the air introduced into the room from the outside; Eliminate the pollutants in the production environment; increase the indoor air static pressure to prevent the outside polluted air from immersing in the room from the door and various leaks. Provide the cleanliness level required by the production process in the clean pharmaceutical cleanroom, and have the necessary facilities for keeping warm, ventilating, cooling, dustproof, anti-pollution, anti-mosquito, anti-insect and anti-foreign matter; The material of the floor is hard, flat and smooth, no gaps, no particulate matter falling off, easy to clean, easy to disinfect, and the connection with the general production area must have a buffer room; personnel entering the clean area must change clothes before entering the production process through the buffer room. .
The number of air dust particles and the number of living microorganisms in the clean workshop should be regularly monitored and recorded. The static pressure difference between adjacent rooms in clean areas with different levels should be kept within the specified value, and appropriate monitoring methods should be provided; temperature and relative The humidity should be adapted to its production and process requirements; an effective dust catcher should be installed in the dust-generating room to prevent cross-contamination of dust; for auxiliary production rooms such as storage, the ventilation facilities and temperature and humidity should be adapted to the requirements of drug production. The clean area should take air cleanliness as the main control object, and at the same time, it should also control the temperature, humidity, fresh air volume, pressure difference, illuminance, noise level and other parameters of the environment accordingly. The content to be verified includes at least temperature, humidity, pressure difference , suspended particles, microorganisms. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for pharmaceutical clean workshops and purification workshops.
The temperature and relative humidity of the clean area should be adapted to the production process and meet the requirements of human comfort. Except for special requirements, the temperature should generally be controlled at 18-28℃, and the relative humidity should be 45%-65%; For Class A, B, and C clean workshops, in order to take into account the inhibition of bacterial production and wearing sterile clothing, the lower temperature should be taken, that is, 20-24°C; Class D clean room is 24-26°C, and the general area air conditioner is 26°C -27℃, 45%-65% relative humidity; 45%-50% for moisture-absorbing products; 50%-55% for solid preparations such as tablets; 55%-65% for water injection and oral liquid; Mold grows. Too low relative humidity is easy to generate static electricity, which makes the human body feel uncomfortable. At the same time, the relative humidity is increased by 5%, and the energy consumption is increased by about 10%.
The noise level in the clean workshop should not exceed 75dBA during dynamic test; during static test, the noise level should not exceed 60dBA; the noise level of laminar flow clean room should not exceed 65dBA. A certain amount of fresh air should be maintained in the clean workshop, and its value should take the maximum value of the following air volumes: 10%-30% of the total air supply volume of non-unidirectional flow clean rooms, and 2% of the total air supply volume of unidirectional flow clean rooms -4%; compensate for the fresh air volume required for indoor exhaust and maintain positive pressure; ensure that the indoor fresh air volume is greater than 40m3/(person.h). Floor drains shall not be set in the clean area of u200bu200bA clean area of u200bu200baseptic operation, and pools and floor drains shall be avoided in the B-level and C-level areas of aseptic operation.
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