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PHARMA CLEAN
Suzhou Pharma is one of cleanroom manufacturers has a full experiences team in handling international cleanroom projects and equipment. More than 17 years of experience in clean room industry among pharmaceutical, medical, chemical, electronic, cosmetic, manufacturing, plastic injection molding and food industry, Suzhou Pharma Machinery is favored by customers all over the world. They have given high attention and recognition to our cleanroom design and solutions. Customers expressed high satisfaction with our cleanroom engineering and services and expressed their willingness to cooperate with us further. As the most trusted partner, SZ-Pharma are fully compliant to cleanroom technology standards as we’re certified to Iso standard and famous for our detail-oriented.
ABOUT CLEANROOM
We provide cleanroom and aseptic area for our customers, in which factors such as the number of particles in the air, humidity, temperature and static electricity can be controlled to achieve specific cleaning standards. They are widely used in high-tech industries such as semiconductors, cell & gene therapy, environmental testing, aviation, aerospace, and bio-medicine.
WHAT ARE THE CLASSIFICATIONS OF CLEANROOM?
Relative humidity: 45%-60%
Speed wind: horizontal wind speed ≥0.54 m/s; vertical wind speed ≥0.36m/s
Leak detection rate of high efficiency filter: >99.97%。
Illuminance: >300lx-600lx
Noise: ≤75db(dynamic testing)
Grade A cleanrooms have strict requirements. They require efficient filters, differential pressure control, air circulation systems and constant temperature and humidity control systems to achieve their high cleanliness requirements. Grade A cleanroom is mainly used in microelectronics processing, bio-pharmaceutical, precision instrument manufacturing, aerospace and other fields.
Relative humidity: 45%-60%
Room ventilation frequency: 40-60 times/hour
Differential pressure：Grade B area is ≥10Pa relative to the outdoor area, and different areas of the same level should maintain a certain pressure difference according to the direction of air flow.
Leak detection rate of high efficiency filter: >99.97%
Illuminance:>300lx-600lx
Noise: ≤75db(dynamic testing)
Grade B cleanrooms usually use efficient filters and exhaust systems to control humidity, temperature and pressure differences in the indoor environment. Grade B cleanroom is mainly used in bio-medicine, pharmaceutical manufacturing, precision machinery and instrument manufacturing and other fields.
Relative humidity: 45%-60%
Room ventilation frequency: 20-40 times/hour
Differential pressure：Grade C area is ≥10Pa relative to the outdoor area, and different areas of the same level should maintain a certain pressure difference according to the direction of air flow.
Leak detection rate of high efficiency filter: >99.97%
Illuminance:>300lx-600lx
Noise: ≤75db(dynamic testing)
Grade C cleanroom typically use efficient filters, positive pressure control, air circulation and temperature and humidity control to achieve their specific cleanliness standards. Grade C cleanroom is mainly used in pharmaceutical, medical device manufacturing, precision machinery and electronic components manufacturing and other fields.
Relative humidity: 45%-60%
Room ventilation frequency: 6-20 times/hour
Differential pressure：Grade D area is ≥10Pa relative to the outdoor area, and different areas of the same level should maintain a certain pressure difference according to the direction of air flow.
Leak detection rate of high efficiency filter: >99.97%
Illuminance:>300lx-600lx
Noise: ≤75db(dynamic testing)
Grade D cleanrooms usually use common high efficiency filters and basic positive pressure control and air circulation systems to control the indoor environment. Grade D cleanroom is mainly used in general industrial production, food processing and packaging, printing, warehousing and other fields.
WHAT ARE THE STANDARDS OF CLASSIFICATIONS?
Clean classification 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 cleanroom 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 cleanroom is in normal working condition, the equipment is operating normally, and there are designated personnel operating in accordance with the specifications.
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.
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.
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 cleanrooms 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.
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 ISO1 to 9. Among them, Grade A is equivalent to ISO 5(static&dynamic state); Grade B is equivalent to ISO 5(static state), ISO 7(dynamic state); Grade C is equivalent to ISO 7(static state), ISO 8(dynamic state);Grade D is equivalent to ISO 8(static state), none required(dynamic state).
ISO 14644-1 Cleanroom Standards
| Class | >=0.1μm | >=0.2μm | >=0.3μm | >=0.5μm | >=1μm | >=5μm | FED STD 209E equivalent |
| ISO 1 | 10 | 2 | |||||
| ISO 2 | 100 | 24 | 10 | 4 | |||
| ISO 3 | 1000 | 237 | 102 | 35 | 8 | Class 1 | |
| ISO 4 | 10000 | 2370 | 1020 | 352 | 83 | Class 10 | |
| ISO 5 | 100000 | 23700 | 10200 | 3520 | 832 | 29 | Class 100 |
| ISO 6 | 1000000 | 237000 | 102000 | 35200 | 8320 | 293 | Class 1000 |
| ISO 7 | 352000 | 83200 | 2930 | Class 10000 | |||
| ISO 8 | 3520000 | 832000 | 29300 | Class 100000 | |||
| ISO 9 | 35200000 | 8320000 | 293000 | Room Air |
Different grades of cleanrooms have their own scope of application, and they can be selected according to actual needs. In practical applications, the environmental control of cleanroom is an 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 cleanroom environment.
WHAT ARE THE TYPES OF CLEANROOM?
Cleanrooms are mainly classified according to indoor cleanliness, air flow form, control object, indoor net height and structural characteristics. In this article, we will classify them according to airflow patterns.
Turbulent Flow
That is, the air enters the cleanroom from the air conditioning box through the air duct and the air filter (HEPA) in the cleanroom, and the air is returned by the wall panels or elevated floors of the two sides of the cleanroom. An irregular turbulent or eddy state in which the air flow is not linear in motion. This type is suitable for cleanroom class 1,000-100,000.
Advantages: simple structure, system construction cost, the expansion of cleanroom is relatively easy, in some special use places, can use a dust-free workbench to improve the level of cleanroom.
Disadvantages: Dust particles caused by turbulence floating in the indoor space is not easy to discharge, easy to pollute the process products. In addition, if the system stops running and reactivates, it often takes a considerable period of time to achieve the required cleanliness.
Laminar Flow
This type is suitable for the class1-100 cleanroom. There are two types:
a.horizontal layer flow: the horizontal air from the filter in a single direction, by the side of the wall of the return air system return air, dust wind discharged to the outside, generally in the lower side of the pollution is more serious. Advantages: simple structure, can become stable in a short time after operation. Disadvantages: The construction cost is higher than the turbulence, and the interior space is not easy to expand.
b.vertical layer flow: The air is blown from top to bottom, which can obtain a high degree of cleanliness, and the dust generated by the process or staff can be quickly discharged outside. Advantages: Easy management and not easy to be affected. Disadvantages: The construction cost is high, the elastic use of space is difficult; and the maintenance and replacement of the filter is more troublesome.
Mixed Type
The compound type is a combination of turbulent flow and stratified flow, which can provide local ultra-clean air.
a. Clean Tunnel : HEPA or ULPA filter will cover 100% of the clean area to improve the cleanliness level, which can save installation and operation costs. This model isolates the work area from product and machine maintenance to avoid compromising quality during machine maintenance.
b. Clean pipe : the automatic production line is surrounded and purified, and the cleanliness level is raised to more than 100. A small amount of air supply can be obtained with good cleanliness, which can save energy, and automated production lines are the most suitable for use.
c. Clean Spot: the cleanliness level of the product process area of the turbulent clean room with a clean room class of 10,000 to 100,000 is raised to more than 10 to 1000 for production purposes; Clean workbench, clean work shed, clean air cabinet is such.
WHAT ARE THE BASIC SYSTEMS OF CLEANROOM?
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, easy to clean, low noise.
(1) Partition wall
Materials: sandwich panel, glass wall
Requirement: heat insulation, sound insulation, anti-corrosion, fire prevention, easy to clean, low volatile concentration, anti-static, installation tightness.
(2) Ceiling
Material: colored steel panel
Requirement: heat insulation, sound insulation, anti-corrosion, fire prevention, easy to clean, low volatile concentration, anti-static, installation tightness.
(3) Floor
Material: epoxy resin, PVC
Requirement: anti-corrosion, fireproof, easy to clean, low volatile concentration, anti-static.
(4) Doors and Windows
Main material: Steel doors, Stainless steel doors, Melamine resin door, Colored steel doors; double layer glass viewer windows
Requirement: anti-corrosion, fireproof, easy to clean, low volatile concentration, anti-static.
HVAC 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.
(1) Lighting: Special clean light are needed.
(2) Power with short, socket: Concealed installation.
(3) Wireless device (telephone, network, surveillance, etc.): Concealed installation.
(4) Fire alarm: Concealed installation.
(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.
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