Clean air conditioning engineering, also known as cleanroom engineering, is usually divided into clean air conditioning projects ranging from Level 1 to Level 10, Level 100, Level 1000, Level 10000, Level 100000, and Level 300000;

Clean air conditioning engineering technology was born in the 20th century? In the 1960s, China's air purification technology has developed rapidly in the past 14 years. This technology is not only needed in military and high-tech industries, but also widely used in industries such as environmental protection, medical care, food, textiles, and agriculture. Especially in recent years, it has played an important role in the production of integrated circuits, operating rooms and treatment nursing for special diseases, and the promotion of quality management standards (GMP) in the pharmaceutical industry. It has indeed become one of the symbols of modernization of production activities and scientific experiments in China.

Control method of cleanliness:
The requirements are met through a three-stage filtration process, consisting of a primary filter, a medium efficiency filter, and a (sub) high efficiency filter. The primary filter is capable of filtering out dust particles ≥ 10um, with a filtration efficiency of around 40-80%,
① Primary filter
Application example:
1. Used for indoor air supply systems without dust control requirements
2. Used for inlet air filtration of fans, heat exchangers, and heaters
3. Pre filters, etc;
② The medium efficiency filter can filter out dust particles ≥ 1um, with a filtration efficiency of about 90-99%,

Application example:
1. Used for various air conditioning intake systems;
2. Laboratory, telephone exchange room, radio broadcasting room. Small computer air-conditioned room;
3. Spray booth air supply;
4. Various operating rooms, electronic equipment rooms
5. Air conditioning in the control area of the pharmaceutical factory

③ The sub high efficiency filter can filter out dust particles ≥ 0.5um, with a filtration efficiency of about 95~99.9.
Application example:
1. Precision instrument constant temperature and humidity chamber, testing room;
2. Various factories and hospitals require clean air-conditioned rooms of 100000 level

④ The high-efficiency filter can filter out dust particles with a thickness of ≥ 0.3um, with a filtration efficiency of about 99.97%,
Application example:
1. Cleanrooms, biological cleanrooms, and sterile wards above the 10000 level;
2. Aseptic operating box, clean room, biological clean safety cabinet;

Clean air conditioning engineering solution:

The clean room requires a space for human activities with controlled dust particle pollution and air cleanliness reaching the specified level. Its function is to control the pollution of particles. In order to achieve the prescribed cleanliness level, effectively control particle pollution, and enable people to engage in precision production and scientific experimental activities.
A clean room is not just limited to "cleanliness", but must be a multifunctional complex with considerable requirements for cold, heat, noise, illumination, static electricity, and micro vibration

The main components of a clean room are shown in the following figure:

A successful cleanroom must first have a good architectural layout and spatial arrangement, considering the flow of people and logistics, and setting up necessary technical interlayers and technical lanes according to the routing of mechanical and electrical pipelines. We need to consider the flexibility of production development. Attention should also be paid to fire prevention and evacuation in clean workshops.

1、 Cleanroom enclosure structure
The key to choosing decorative materials for the cleanroom enclosure structure is to ensure the airtightness of the cleanroom and that the material surface does not produce dust, retain particles, or accumulate dust. Also pay attention to the static electricity effects generated by decoration and human body.
The suspended ceiling and partition walls of prefabricated cleanrooms generally use metal wall panels (such as color steel rock wool sandwich panels, color steel gypsum sandwich panels, color steel phenolic sandwich panels, etc.)
The floor of the clean room generally adopts terrazzo floor, epoxy resin self leveling floor, polyurethane coating, anti-static PVC plastic floor or anti-static elevated ventilation floor.

(Photos of metal wall panels and floors)

2、 Clean room air purification - requires at least three levels of filtration: coarse, medium, and high-efficiency
1. Centralized purification air conditioning system

2. Distributed purification air conditioning system

Classified by airflow pattern:
Unidirectional flow clean room - the basic form of airflow is similar to the piston movement inside a cylinder, which pushes out the dust and bacterial pollutants emitted by the pollution source before they diffuse into the room; Clean air plays a role in isolating pollution sources, blocking the spread of dust and bacterial pollutants indoors.
Non unidirectional flow cleanroom - achieves purification through dilution method, using clean air treated with high-efficiency filters to dilute pollutants and maintain the required air cleanliness level indoors.
Mixed flow and its clean room - Mixed flow clean room is a combination of non unidirectional flow pattern and unidirectional flow pattern used in the same clean room. The equipment and operating costs of one-way flow cleanrooms are high, but in some practical cleanroom projects, strict cleanliness requirements are often only imposed on certain areas, rather than the entire cleanroom (zone). The characteristic of a mixed flow clean room is to use a unidirectional flow pattern in areas where strict air cleanliness is required, while others are non unidirectional flow patterns. This not only meets the usage requirements, but also saves equipment investment and operating costs. The general form of a mixed flow clean room is that the entire clean room is a non unidirectional flow clean room, and a unidirectional flow type clean measure is adopted above the area that requires strict air cleanliness, so as to obtain a unidirectional flow type clean area that meets the requirements and prevent the relatively poor air environment around from affecting the local high cleanliness.

3. Cleanroom related equipment and components (see "Product Display" for pictures)
Clean workbench
laminar hood
Residual pressure valve
pass box
Air Shower
Cargo shower room

3、 Power facilities for clean rooms
1. Freezing station building

2. Pure water preparation system (click to enter)）

3. Compressed air, vacuum, and nitrogen pipeline system diagram

4. Electrical equipment and lighting

4、 Cleanrooms involve other technical fields - environmental control
1. Micro vibration control
2. Electrostatic protection
3. Prevention of electromagnetic interference
4. Noise control

GMP - Good Manufacturing Practice
The implementation of GMP system for drugs is a means of national supervision and inspection of drug production enterprises, an important part of drug supervision and management, and a scientific and advanced management method to ensure drug quality.
The National Medical Products Administration is responsible for the national drug GMP certification
The Drug Certification Management Center of the National Medical Products Administration undertakes the specific work of drug GMP certification
EU GMP - EU GMP Guidelines
FDA - US Food and Drug Administration
EU GMP certification

Biological Cleanroom - Targeting the Control of Living Particles
Application industries: pharmaceuticals, biotechnology, healthcare, food, cosmetics, animal laboratories, biosafety laboratories, etc
GMP certification is a mandatory safety certification that integrates software, hardware, safety, hygiene, and environmental protection.
The significance of international certification itself is not only to strengthen the process control of various quality factors within pharmaceutical factories, but also to control key external quality factors of pharmaceutical factories.
Cleanroom technology is a necessary condition for implementing GMP:
The purpose of controlling the pharmaceutical production environment is to prevent situations that may endanger product quality, such as contamination or cross contamination.
The pollution control objects of clean rooms used in drug production include dust particles and microorganisms, and microorganisms in the air mainly adhere to dust particles.

The biggest feature of pharmaceutical industry purification air conditioning is that the manufacturing process itself is a source of dust, especially the manufacturing process of solid preparations is more prominent. In this type of clean room, using local dust removal method is the most effective and economical. If the operating room with a high amount of dust does not use a local dust removal device and relies solely on air conditioning to achieve a clean room of 100000 levels, the air conditioning cost is likely to exceed the cost of a sterile room. However, due to the easy flying of tiny dust particles, such as particles below 100um, which can also be lifted in a gentle breeze of 0.5m/s, excessive vacuuming will undoubtedly increase drug loss.

In the production of sterile injectable preparations, if the drugs are not subjected to final sterilization treatment such as high-pressure steam disinfection, but only produced by preparing and sealing sterile raw materials under sterile conditions, then such sterile operating rooms are generally managed as biological clean rooms with a bacterial count of less than 1 (on vessels with a diameter of 9cm, within one hour)
The preparation and sealing room for general injections that undergo sterilization treatment, or the operating room for producing other formulations in a sterile state, are also managed as sterile purification areas. With the implementation of GMP, cross contamination and microbial contamination are also treated as issues in the production process of some non sterile preparations
Air purification equipment is the improvement and supplement of production equipment and production management. It is not enough to rely solely on air conditioning to prevent microbial contamination or cross contamination. Even with purification equipment, it may not fully meet GMP requirements. It must be noted that once the equipment conditions reach a certain level, management must also be implemented to achieve this.
Penicillin is prone to flying and suspending, so its air conditioning system should be separated from non penicillin preparation operating rooms, set up separately to prevent cross contamination, and maintain a certain distance from the fresh air vents of other operating room air conditioning systems. The purpose of setting up a separate air conditioning system is to create a direct current system for exhaust, preventing the air conditioning system in the penicillin antibiotic operating room from circulating to the operating rooms of other preparations.
Generally speaking, in the production of solid preparations, the powder is processed in a dry state during various processes such as weighing, mixing, granulation, drying, slicing, sealing and filling, and powder filling. Inevitably, drug dust will be generated. Therefore, in addition to adopting local exhaust measures for the layout or structure of the operating room and the areas where dust is generated, it is also necessary to comprehensively solve the problem of cross pollution through laminar flow and other air conditioning methods.
In the manufacturing of special preparations such as penicillin, internal dust is not allowed to flow to the outside. In this case, it is necessary to set up a separate operating room or create negative pressure to make the pressure lower than other operating rooms. Especially when the enclosure structure of the operating room is in direct contact with the atmosphere, it must be tightly sealed

Management Measures for Drug GMP Certification:
Article 5: Pharmaceutical production enterprises (workshops) applying for GMP certification shall fill out two copies of the "Application for GMP Certification" in accordance with regulations and submit the following materials
1. Copy of Drug Production Enterprise License and Business License;
2. Self inspection of drug production management and quality management (including enterprise overview, GMP implementation, and training);
3. Registration form for the educational level of the person in charge and inspection personnel of pharmaceutical production enterprises (workshops); Table of the proportion of high, medium, and junior technical personnel;
4. Organizational chart of pharmaceutical production enterprises (workshops) (including the functions and interrelationships of each organizational department, department heads);
5. List of all dosage forms and varieties produced by pharmaceutical manufacturing enterprises (workshops);
6. Environmental conditions, storage, and overall layout plan of pharmaceutical production enterprises (workshops);
7. Overview and process layout plan of the drug production workshop (including changing rooms, washrooms, pedestrian and material passages, airlocks, etc., and indicating the air cleanliness level);
8. Production formulation or variety process flow chart, and indicate the main process control points;
9. The key processes of pharmaceutical production enterprises (workshops), the verification status of main equipment, and the calibration status of inspection instruments and meters;
10. Catalog of production management and quality management documents for pharmaceutical manufacturing enterprises (workshops).

Industrial cleanroom - focusing on the control of non living particles
Application industries: precision industry, electronics industry, aerospace industry, chemical industry, atomic energy industry, printing industry, photography industry
Color tube industry, microelectronics industry, optoelectronics, opto mechatronics integration industry, etc
Industrial cleanrooms have raised updated and higher requirements for clean production environments:
The control range of air purification in industrial cleanrooms has expanded from dust particles to molecular and chemical pollution - using activated carbon filters, PTFE air filters, chemical filters, etc. that remove molecular and chemical pollutants, and supporting corresponding detection methods.
2. Industrial cleanrooms should control the impurity content of cleaning water, etching chemicals, reaction gases, and carrier gases during production and processing - A. Use ultra-high purity materials. Request to provide ultra pure gases, ultra pure water, etc. with very strict requirements for purity and impurity content. B. Due to the frequent use of toxic gases and solvents, local exhaust equipment must be installed indoors. To maintain positive indoor pressure, the fresh air volume should be greater than the exhaust air volume. C. The raw materials used in the production process include both acids and solvents. For different situations, polyethylene materials are used for the interior decoration surface layer, while stainless steel materials are used for the latter.
3. The temperature, relative humidity, anti-static, anti microseismic, noise, illumination and other requirements of industrial cleanrooms are strictly controlled within a very strict range. ——A. Indoor temperature and humidity changes should be minimized to prevent product expansion or contraction. In order to process integrated circuits at the sub micron and deep sub micron levels, it is necessary to control the temperature change of the exposure equipment below+0.1C, and the relative humidity change of the production environment of the photoresist sol process below 2%~5%. B. The installation foundation of various lithography equipment and size measuring instruments should fully consider the issue of microseismic protection. C. In the process of photographic plate making, according to the requirements of photosensitive material performance, shading measures should be considered for lighting, door and window glass, and entrances and exits. The general homework requires an illumination of 600lx or above.
4. Air conditioning equipment usually operates continuously for 24 hours, and remedial measures should be considered in case of malfunction. The layout of indoor gas, water, and electrical pipelines should consider the convenience of renovation.