Application of air-conditioning system in dust-free clean workshop
Application of air-conditioning system in dust-free clean workshop
Environmental classification of dust-free clean workshop:
The dust concentration and microbial biomass in the air are important measures for the environmental conditions of sterile products, especially some biological preparation API dust-free clean rooms. The dust-free clean room grades are determined according to the values u200bu200bof these different measures.. .
Text label: Dust-free clean workshop purification equipment, clean air-conditioning system design
Application of air-conditioning system in dust-free clean pharmaceutical cleanroom
Environmental classification of dust-free clean workshop:
The dust concentration and microbial biomass in the air are important measures for the environmental conditions of sterile products, especially some biological preparation API dust-free clean workshops. The dust-free clean workshop grades are determined according to the values u200bu200bof these different measurement standards.
There are several similar formulations of environmental grades: ISPE guidelines use the ISO standard 'gradeThe limit is 10cfu/m3. By comparison, ISPE's 'level 7' is very similar to the European standard's B-level, the difference is that the European standard's A, B, C, and D levels still have static limits.
my country's GMP adopts the same grading standard as that of the European Union.
How is the dust-free clean workshop level maintained?
Designers may be accustomed to using a clean room class, a 'rule of thumb' that corresponds to the air change rate (number of air changes in the room). Experienced designers only use this method in the design of the scheme, and then adjust the required number of air changes based on further understanding of the process flow.
The designer should consider the relationship between the ventilation rate, the air dust concentration, and the self-cleaning time of the dust-free clean workshop. Although the air exchange rate is an important parameter in the design of the HVAC system in a product factory, there is a closer relationship between the air exchange rate and the self-purification capacity than the classification of the production room. The air exchange rate depends on the size of the room. Arbitrarily setting the ventilation rate and air flow will determine the supply air volume of the room and affect the project investment and life cycle cost.
Dust particle generation rate in dust-free clean workshop:
If the number of particles in the steady state dust-free clean room, the supply air volume of the clean room and the particle content in the supply air are known, the particle generation rate (PGR) can be calculated. The PGR value can then be applied to the same production room in the same facility.
When using empirical data for dust particle monitoring, it should be considered that the particles of the product being processed are not contaminants. For example, when sterile powder is filled, the number of particles is high, which is related to the filling process and is not a clean room design failure.
Although the equipment in operation can generate a large amount of particles, the operator is still the main source of microbial contamination. Strengthening the control of the total number of particles released by the human body can strengthen the control of microbial particles in the clean room.
On the premise of ensuring the indoor cleanliness requirements, the air supply volume of the room can be reduced, but the requirements of indoor temperature and humidity, self-cleaning time, and indoor air volume balance should still be maintained.
Product and process considerations:
HVAC is designed to ensure the comfort of production personnel and to protect those inside and outside the facility from harmful substances in the air. In order to ensure the quality of the products, it is also necessary to ensure the air environment required for the production of the products.
Because, products may be affected by temperature, humidity, air pollution from outside or defined pollution between products, and operators may also be exposed to airborne harmful substances.
Understanding the product and process is the key to good HVAC system design.
Dust-free clean workshop pollution control:
The HVAC system of the dust-free clean workshop should be able to control air pollution to ensure the purity, uniformity and quality of the product. contamination control is typically achieved by feeding purified and filtered air to the workplace, mixing it with ambient air and diluting the contaminants in the pharma clean room air.
The total number of particles and active particles in the clean room
Most dust particles are not viable, only a small fraction (<1%) of particles are viable, such as bacteria, they can reproduce, so these active particles with microorganisms are together with particles without microorganisms movement, thereby contaminating other particles. Zhongjing Global Purification can provide consulting, planning, design, construction, installation,
Reconstruction and other supporting services.
The effect of temperature and humidity on pollution control?
Healthy people produce very few environmental pollutants: an average worker releases 100,000 particles (particle size ≥ 0.3 μm) per minute while working essentially sitting. A feverish, unwell worker could release millions of particles in these size ranges, including many more bacteria, every minute. Higher temperatures and humidity also accelerate the growth of surface microorganisms and mold,
This has an impact on product quality.
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