ISO5-ISO8 Cleanroom
What is ISO clean room?
An ISO clean room is a controlled environment that meets the cleanliness standards set by the International Organization for Standardization (ISO) in their series of standards ISO 14644. These standards define the air cleanliness by specifying the maximum concentration of particles in the air per unit volume, based on particle size. The classification system ranges from ISO 1 to ISO 9, with ISO 1 being the cleanest and ISO 9 having the most particles.
In an ISO clean room: Airborne particulate levels are tightly controlled and regularly monitored.The number and size of particles per cubic meter of air are specified; smaller numbers indicate stricter control over particulates. Particles include dust, hair, skin flakes, fibers, and other contaminants that can affect manufacturing processes, particularly those in industries such as semiconductor manufacturing, pharmaceuticals, biotechnology, medical device production, and aerospace where high levels of precision and contamination control are critical.
For instance, an ISO Class 5 cleanroom allows no more than 10,000 particles equal to or larger than 0.1 microns per cubic meter of air, while an ISO Class 1 cleanroom allows just 12 particles of the same size per cubic meter.
The design and operation of ISO clean rooms involve sophisticated air filtration systems, careful material selection, gowning procedures for personnel, and strict operational protocols to maintain the required level of cleanliness.
|
Class |
Maximum particles/m³ |
FED STD 209E equivalent |
|||||
|
>=0.1μm |
>=0.2μm |
>=0.3μm |
>=0.5μm |
>=1μm |
>=5μm |
||
|
ISO 1 |
10 |
2 |
|||||
|
ISO 2 |
100 |
24 |
10 |
4 |
|||
|
ISO 3 |
1,000 |
237 |
102 |
35 |
8 |
Class 1 |
|
|
ISO 4 |
10,000 |
2,370 |
1,020 |
352 |
83 |
Class 10 |
|
|
ISO 5 |
100,000 |
23,700 |
10,200 |
3,520 |
832 |
29 |
Class 100 |
|
ISO 6 |
1,000,000 |
237,000 |
102,000 |
35,200 |
8,320 |
293 |
Class 1,000 |
|
ISO 7 |
352,000 |
83,200 |
2,930 |
Class 10,000 |
|||
|
ISO 8 |
3,520,000 |
832,000 |
29,300 |
Class 100,000 |
|||
|
ISO 9 |
35,200,000 |
8,320,000 |
293,000 |
Room air |
|||
BRIEF INTRODUCTION:
Clean room (also known as cleanroom): A room with a controlled concentration of airborne particles.
SUZHOU PHARMA MACHINERY has kinds of clean room: iso5 cleanroom, iso 6 cleanroom, iso 8 cleanroom,iso7 cleanroom.Its construction and usage should reduce indoor inducement and generation of retained particles.
Other relevant indoor parameters such as temperature, humidity, pressure, etc. are controlled as required. It should be pointed out that the clean room can not completely eliminate the pollution, but control it at an acceptable level.
As a result, GMP began to define and control the sources of particulates,to try to control possible "microbial contamination.".
The presence of personnel in clean rooms is usually the highest source of risk of particulate and microbial contamination in the air,so proper gowning and limiting the number of staff into a room must be carefully controlled to be within the clean room design.
It's widely used in water treatment system, liquid filling machine, tablet production line, pharmaceutical machine, oil extraction line, formulation processing plants, filling and packing lines, PET packaging,foil sealing, medical device & pharmaceutical packaging, aseptic manufacturing and repackaging, non-PVC soft bag IV solution production line, etc.
Find details about SuZhou Pharma iso5 cleanroom, iso 6 cleanroom, iso 8 cleanroom,iso7 cleanroom followings.
What is clean room?
Clean room is a controlled environment where the concentration of airborne particles, such as dust, microorganisms, and other impurities, is kept at a very low level. The purpose of a clean room is to minimize the risk of contamination in various industries where high standards of air cleanliness are essential for the manufacturing process or scientific research. Clean rooms use HEPA (High-Efficiency Particulate Air) filters, airlocks, positive or negative air pressure systems, special clothing (like bunny suits), and strict protocols to maintain the desired level of cleanliness. Cleanliness levels are often defined by the number of particles per cubic meter of air at a specific particle size.
Clean rooms are typically used in:
Semiconductor manufacturing: Ensuring that microchips and electronic components are produced without any contamination, which can affect their performance and reliability.
Pharmaceutical and biotechnology: For drug development, medical device assembly, and sterile fill/finish processes to prevent contamination by bacteria, viruses, or other pathogens.
Aerospace: In assembling sensitive components and instruments for spacecraft, satellites, or aircraft where even tiny particles could cause malfunctions.
Medical research: To conduct experiments under highly controlled conditions, such as stem cell research or DNA sequencing.
Microscopy and nanotechnology: Where work on a microscopic scale requires an ultra-clean environment.
CHARACTERISTIC:
The clean room workshop is also called the dust free workshop, gmp cleanroom, the industrial clean room (Clean Room) and the dust free room. It refers to the removal of pollutants such as particles, harmful air and bacteria in the air within a certain space, and the indoor temperature,cleanliness, indoor pressure, air velocity and air distribution, noise and vibration, lighting and static control. A specially designed clean room for a particular requirement. That is to say, no matter how the extemal air conditions change, the clean ro
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