Clean room knowledge summary(2)
3. Different grade standards of Clean room
Clean grade standards are classified according to the concentration of suspended particles in the air. Generally speaking, the smaller the value, the higher the purification level.
Air cleanliness refers to the size and number of particles (including microorganisms) contained in the air per unit volume space, which is the standard to distinguish the cleanliness level of the space.
Static refers to the state of clean room workers after they leave the site and self-clean for 20 minutes when the clean air conditioning system has been installed and fully functional.
Dynamic means that the clean room is in normal working condition, the equipment is operating normally, and there are designated personnel operating in accordance with the specifications.
3.1 Grade A,B,C,D standards
The classification standard of ABCD comes from the GMP issued by the World Health Organization (WHO), which is the common drug production quality management standard in the pharmaceutical industry. It is currently used in most parts of the world, including the European Union and China.
3.2 Other clean area (room) classification standards
Clean areas (rooms) have different grading standards in different regions and different industries. The previous article has introduced the GMP standard, here mainly introduces the United States standard and ISO standard.
3.2.1 USA standard
The concept of classification of clean areas (rooms) was first proposed by the United States, and the first federal standard for the military section of clean rooms was introduced in 1963: FS-209. We are familiar with the 100, million and 100,000 levels are derived from this standard, in 2001 the United States stopped using the FS-209E standard, began to use the ISO standard.
3.2.2 ISO standard
ISO standards are developed by the International Organization for Standardization (ISO) and cover multiple industries, not just the pharmaceutical industry. There are nine levels from class1 to 9. Among them, class5 is equivalent to Class B, Class 7 is equivalent to class C, and Class 8 is equivalent to class D.
Different grades of clean rooms have their own scope of application, and they can be selected according to actual needs. In practical applications, the environmental control of clean rooms is a very important task, involving the comprehensive consideration of many factors, only scientific and reasonable design and operation, in order to ensure the quality and stability of the clean room environment.
4. Basic systems of Clean room
There are four main systems in the clean room: structural decoration system, HVAC system, electrical system and pipeline system.
Prevention and control requirements: no dust, no dust, easy to clean, low noise.
4.1 Structural decoration system
The main body of the clean room is generally in the large space created by the main structure of the civil frame, using the required decoration materials, according to the process requirements to separate and decorate into a clean room to meet various use requirements. The pollution control of clean room needs to be completed jointly by the purification air conditioning profession and the automatic control profession. The system is the skeleton of the clean room, including the building structure and the decoration structure. It mainly includes four parts:
(1) Partition wall
Materials: color steel plate, glass wall.
Requirement: heat insulation, sound insulation, anti-corrosion, fire prevention, easy to clean, volatile concentration, anti-static, installation tightness.
(2) Ceiling
Material: colored steel plate
Requirement: heat insulation, sound insulation, anti-corrosion, fire prevention, easy to clean, volatile concentration, anti-static, installation tightness.
(3) The ground
Material: epoxy resin, PVC
Requirement: anti-corrosion, fireproof, easy to clean, volatile concentration, anti-static.
(4) Doors and Windows
Main material: Aluminum alloy.
Requirement: anti-corrosion, fireproof, easy to clean, volatile concentration, anti-static
4.2 Structural decoration system
HVAC system includes: refrigeration system and ventilation and air conditioning system.
Refrigeration system: chiller, water pump, cold water pipe composition.
The ventilation and air conditioning system consists of a combined air conditioner cabinet, an air duct, a high-efficiency air outlet and an ozone generator.
Components: clean air conditioning group, clean air duct, plenum + high efficiency filter.
Requirement: cleanliness, temperature, humidity, noise, pollutants
4.3 Electrical system
(1) Lighting: Special clean lamps are needed.
(2) Power with short, socket: Concealed installation
(3) Weaknesses (telephone, network, surveillance, etc.):Concealed installation
(4) Fire alarm: Concealed installation
4.4 Pipeline system
(1) Domestic water supply pipe (tap water)
(2) Drainage pipes
(3) pure water pipe
(4) Compressed air pipe
(5) Nitrogen pipe
(6) Steam pipe
(7) Vacuum tube
(8) Fire water system (spray, hydrant, etc.)
Main materials: PPR, stainless steel, compliant material and seamless steel pipe.
To be continued...
Suzhou Pharma Machinery Co.,Ltd.
2023/10/04
Tia
