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Clean room application
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Worldwide standard & PIC/S GMP Guide
HEPA Information
After-sales service

Clean room application

1.Clean Room / Aseptic Clean Room

Clean Room is a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary. Also, the illumination, hazardous steam, and airflow direction and its velocity are also defined.
Aseptic Clean Room is a room where the Microorganisms such as bacteria or virus and biological particles are more strictly controlled.

Industrial Clean Room ICR

It is the Clean Room for industrial use, such as Precision industries, electric industries, etc.

Biological Clean Room BCR

It is the aseptic Clean Room for biological medicine or laboratories. Most of the bacteria or virus are attached to the airborne particles, which can be filtered with Filter System. However, finer bacteria can be sterilized by ultra-violet ray lamp or Hydrogen Peroxide Gas.

2.Features for Clean Room Air-conditioning

I.Temperature and humidity requirements are higher than general air-con.

The temperature requirement for general air-con is between 18°C and 26°C and the relative humidity is between 40% and 65%; while the temperature in Clean Room should be controlled between 22°C and 24°C and the humidity in it should be between 45% and 55%.

II.Constant temperature and humidity control

It is extremely temperature-sensitive for the semiconductor industry; therefore, the temperature and humidity should be controlled within ± 1°C and ± 3% in most of the Clean Room areas.

III.More air needed to balance the air pressure in Clean Room

A large amount of the chemicals and toxic gas will be required during the semiconductor production. Therefore, there will also be a huge amount of gas exhausted due to the volatile gas and exhaust gas. To maintain positive pressure inside the Clean Room, the air supply into the Clean Room is also relatively increased.

IV.Twenty-Four Seven running and monitoring on Air-con system

Part of the machines in the semiconductor production are highly sensitive to the temperature/humidity variation, such as the Stepper in Photo lithography area. A slight change of the temperature or humidity would affect the accuracy of the device. Moreover, the products like chips should be put in the environment with constant temperature and humidity. Therefore, the air-con system should be strictly monitored and managed.

V.Air pressure inside the Clean Room in the semiconductor factories

For the semiconductor factories, the air pressure in the Clean Room should be higher than the outside. Besides avoiding the influence from the temperature, humidity, and particles outside the Clean Room, it also helps extend the lifetime of the ULPA filter. However, the pressure difference should be constrained to avoid the cost increase from the increased out bounding air from Clean Room.

VI.Airflow direction

In order to remove the airborne particles inside the Clean Room, the air velocity shall reach the certain standard. Also, the airflow direction shall be controlled based on various levels of the Clean Room.

3.Clean Room System

The Clean Room system would produce clean air that is conformed to the specification. The clean air shall be steadily and continuously supplied to the FAB. Generally speaking, the source for producing clean air is called OUTSIDE AIR. It will undergo various of processing units in the Clean Room to produce the clean air that conforms to the specification. The following is the simplified process: The Outside air goes into the Make-up Air Unit (or MAU) to pre-filter the particle and control the temperature/humidity. After that, the air goes to the Mech. Chase. Inside the Chase, the circular air in the Clean Room and the supplying air from the MAU are mixed, and Dry Cooling Coil will cool down the air inside the Mech. Chase to the requested temperature by the Clean Room specification. Then the Fan Filter Unit (or FFU) enables the airflow cycle in the Clean Room to remove the particles and heat. Last, the air will be supplied to FAB area after filtered by the Ultra-low penetration air (or ULPA Filter).

4.Definition of Cleanliness

It means the capability for the Clean Room to effectively control the particle number in the specific room. To define the function of different types of the Clean Room, we define it based on the particles of “Specific Size” in “Specific Volume”.
Take the particle diameter above 0.5μm for example:

Countryside		10,000,000 – 50,000,000 particles/m³
City		100,000,000 – 500,000,000 particles/m³
Indoors		100,000,000 – 1,000,000,000 particles/m³
ISO Class 5		control within 3,520 particles/m³
FS 209E Class 100		control within 3,520 particles/m³

5.Clean Room Classifications

Industry			Cleanliness
			ISO 2	ISO 3	ISO 4	ISO 5	ISO 6	ISO 7	ISO 8
			-	209E Class 1	209E Class 10	209E Class 100	209E Class 1,000	209E Class 10,000	209E Class 100,000
ICR	Semiconductor chip manufacturer
	Semiconductor component supplier	Front end
	Semiconductor component supplier	Back end
	LCD Manufacturer
	Hard Disk manufacturer
	Precision industry manufacturer
	Mask manufacturer
	PCB manufacturer
BCR	Pharmaceutical manufacturer	Filling area
	Pharmaceutical manufacturer	Packing area
	Hospital	Aseptic therapy room
	Hospital	Aseptic operation room
	Food processing manufacturer	UHT milk
	Food processing manufacturer	Fresh vegetables, fruits, boxed meal, bread
	Animal laboratory	Aseptic animal laboratory
	Animal laboratory	SPF animal

Solutions

1.Electronics/Semiconductors

With increasing demands for quality and safety, the need for cleanroom technology continues to rise. The global cleanroom technology market is projected to grow from $9.37 billion in 2024 to $13.21 billion in 2029, demonstrating robust momentum.

Data indicates that semiconductor cleanrooms account for 61% of total cleanroom floor area, highlighting their critical role.The cleanroom environment is critical to semiconductor manufacturing, as the industry heavily relies on cleanroom technology to produce precision microelectronic components. Semiconductor chips are widely integrated into various electronic devices, including mobile phones, household appliances, automobiles, defense systems, and aerospace technologies. Moreover, with the rapid expansion of 5G networks, the proliferation of Internet of Things (IoT) devices, and the growing adoption of Artificial Intelligence (AI) and Machine Learning (ML) applications, the demand for semiconductors continues to rise, driving manufacturers to scale production capacities to meet market needs.

AIRTECH specializes in delivering high-performance, reliable cleanroom technology solutions tailored to the semiconductor industry. Our advanced systems are designed to enhance production efficiency while meeting stringent quality standards. We are committed to collaborating with our clients to facilitate the production of high-quality chips that cater to diverse industry applications, driving continuous progress in the technology sector.

Cleanroom Fan Filter Unit(FFU)- Typically installed on cleanroom ceilings, this equipment purifies the air to effectively maintain the cleanliness of the indoor environment.
Thermal Clean Chamber(TCC)- Certain semiconductor manufacturing processes are highly sensitive to fluctuations in temperature and humidity. Many products must also be stored in controlled environments with constant temperature and humidity, making precision climate control systems essential.
Pressure Relief Damper(APD)- To prevent external contaminated air from entering the cleanroom, Pressure Relief Dampers (also known as pressure equalizers) are utilized to regulate and maintain a slight positive pressure within the room.

2.Clinics

In the medical industry, the equipment in the diagnosis and treatment rooms requires a clean environment to prevent germs from affecting the health of patients and medical staff. Self Assembly Air Shower(AAS) can be set up from the beginning when people enter and exit, and high-volume air filters can also be placed in public areas. These equipment can quickly improve air quality and reduce the concentration of suspended particles.

In clinical settings, Partitioned Air Purifier (ACP) can be strategically placed to safeguard healthcare personnel and purify contaminated indoor air. Our systems incorporate large-area HEPA filters with an efficiency of 99.99% for particles as small as 0.3μm, effectively eliminating airborne bacteria and pathogens, preventing viral transmission, and reducing cross-contamination. These solutions create a safe treatment environment, offering patients enhanced peace of mind.

High-Capacity Air Purifier Unit(PAU)- Featuring an oversized air outlet design, our systems rapidly improve air cleanliness in large spaces. They are ideal for offices, retail stores, clinics, schools, and other commercial facilities requiring High-Capacity Air Purifier Unit(PAU).
Self Assembly Air Shower(AAS)- The Self Assembly Air Shower is our most efficient product, offering modular and highly adjustable configurations. The dimensions of the unit can be tailored to fit your specific spatial requirements, making it exceptionally suited for rapid deployment and installation.
Partitioned Air Purifier(ACP)- The Partitioned Air Purifiers are easy to place and deliver robust performance in purifying contaminated indoor air. They effectively remove bacteria and pathogens from the air, preventing viral spread and cross-contamination, thereby enhancing safety for healthcare professionals and patients alike.

3.Food Industry

Food processing involves multiple stages, from raw material handling to packaging and distribution, with each step requiring strict compliance with hygiene and cleanliness standards.

Whether producing pastries, dairy products, or packaged beverages, our solutions enhance product hygiene and safety while helping enterprises meet international standards such as HACCP and ISO 22000, delivering higher-quality food experiences for consumers.

To meet the specific hygienic requirements and applications of various food industries, we offer specialized air curtains designed for cold storage facilities to prevent cold air leakage from storage areas. Additionally, our range of pest control equipment—including Insect-Proof Air Curtain, Commercial Insect Light Trap, and Door Type Insect Light Trap (Bug Shield) addresses contamination risks from pests at their source, reducing potential pollutants and ensuring operational integrity.

Insect-Proof Air Curtain(AAC)- The air curtain forms a high-speed air barrier by blowing out the airflow of the turbulent flow system, which can effectively disrupt insects and prevent them from passing through. It can also reduce other small foreign objects and pollutants.
Commercial Insect Light Trap(ABK)- Solve the problem of foreign matter mixing caused by insects in mosquito source areas, use insect traps to attract insects, and then use suction fans to capture invading insects. ※Our company's products all use physical trapping technology.

4.Pharmaceutical/Cosmetic Manufacturing

The production of pharmaceuticals and cosmetics must adhere to GMP standards, requiring a high level of cleanliness throughout every stage, from manufacturing to storage. To assist in controlling particulate and microbial contamination, we provide comprehensive solutions, including Biosafety Cabinets, Nexcell, Clean Booths, Laminar Flow Benchs, and Pass boxes.

Particularly in aseptic filling and cell culture processes, our equipment ensures compliance with regulatory requirements at every stage of production, achieving high stability and minimizing contamination risks. This enables the production of safer, higher-quality products.

Biosafety Cabinet (Class ⅡB2)、Biosafety Cabinet (Class ⅡA2)- Designed for handling biohazardous materials, these cabinets are equipped with a negative pressure air filtration system to ensure containment and prevent leakage of hazardous substances.
Nexcell- This cutting-edge equipment is the result of a collaborative effort by three leading Japanese companies—AIRTECH, WAKENYAKU CO.,LTD., and TOMY DIGITAL BIOLOGY CO., LTD. contributing expertise from their respective fields.
Vertical Laminar Flow Bench (VS)- The Bench provides a localized clean and sterile working environment. It includes a controlled exhaust system to filter and safely discharge contaminated air from the workspace, protecting both operators and the environment. The Bench is an ideal solution for microbiological applications requiring safety and precision.

5.Hospitals

Operating rooms, laboratories, and isolation wards in hospitals must maintain a high level of cleanliness to prevent cross-contamination and the spread of pathogens. We provide advanced medical-grade cleanroom equipment, including Pass boxes, Negative Pressure Isolation Stretcher, Specimen Collection Booth, Positive pressure testing booth,Hydrogen Peroxide Sterilizers (Gas Generator) and Packaged exhaust unit, designed to create safe and reliable medical environments.

From sample transfer to air sterilization, our integrated solutions address diverse medical needs, ensuring patient safety, improving healthcare efficiency, and establishing contamination-free operations that meet international medical standards.

Negative Pressure Isolation Stretcher(BS-Cap-Ⅲ)- The capsule maintains a negative pressure environment, isolating viruses and bacteria expelled by patients during coughing. This effectively prevents cross-infection by filtering contaminated air through high-efficiency HEPA filters and releasing purified air back into the environment.
Packaged exhaust unit(PEU)- Designed for infection control, this unit prevents the spread of infectious diseases and ensures the safety of healthcare personnel and patients. Contaminated air is filtered through high-performance HEPA filters, with clean air discharged outdoors. It prevents cross-contamination between isolation zones and other areas, such as offices or rest zones, while maintaining a negative pressure environment.

Worldwide standard

Cleanliness

The cleanroom classification standards FS 209E and ISO 14644-1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area.

ISO 14644-1

Maximum concentration limits (particles/m³ )
Classification Number (N)	0.1μm	0.2μm	0.3μm	0.5μm	1.0μm	5.0μm
ISO Class 1	10	-	-	-	-	-
ISO Class 2	100	24	10	-	-	-
ISO Class 3	1,000	237	102	35	-	-
ISO Class 4	10,000	2,370	1,020	352	83	-
ISO Class 5	100,000	23,700	10,200	3,520	832	-
ISO Class 6	1,000,000	237,000	102,000	35,200	8,320	293
ISO Class 7	-	-	-	352,000	83,200	2,930
ISO Class 8	-	-	-	3,520,000	832,000	29,300
ISO Class 9	-	-	-	35,200,000	8,320,000	293,000

Federal Standard 209E Airborne Particulate Cleanliness Classes

CR Cleanliness		Diameter for Airborne Particle
		0.1μm		0.2μm		0.3μm		0.5μm		0.5μm
		Volume Units		Volume Units		Volume Units		Volume Units		Volume Units
SI	Class	(m³)	(ft³)	(m³)	(ft³)	(m³)	(ft³)	(m³)	(ft³)	(m³)	(ft³)
M1		350	9.91	75.7	2.14	30.9	0.875	10.0	0.283	-	-
M1.5	1	1240	35.0	265	7.50	106	3.00	35.3	1.00	-	-
M2		3,500	99.1	757	21.4	309	8.75	100	2.83	-	-
M2.5	10	12,400	350	2,650	75.0	1,060	30.0	353	10.0	-	-
M3		35,000	991	7,570	214	3,090	87.5	1,000	28.3	-	-
M3.5	100	-	-	26,500	750	10.600	300	3,530	100	-	-
M4		-	-	75,700	2,140	30,900	875	10,000	283	-	-
M4.5	1000	-	-	-	-	-	-	35,300	1,000	247	7.00
M5		-	-	-	-	-	-	100,000	2,830	618	17.5
M5.5	10,000	-	-	-	-	-	-	353,000	10,000	2,470	70.0
M6		-	-	-	-	-	-	1,000,000	28,300	6,180	175
M6.5	100,000	-	-	-	-	-	-	3,530,000	100,00	24,700	700
M7		-	-	-	-	-	-	10,000,000	283,000	61,800	1,750

JIS B 9920

Class	Maximum concentration limits (particles/m³ )
Class	0.1μm	0.2μm	0.3μm	0.5μm	1μm	05μm
Class1	10	2	-	-	-	-
Class2	100	24	10	4	-	-
Class3	100	237	102	35	8	-
Class4	10,000	2,370	1,020	352	83	-
Class5	100,000	23,700	10,200	3,520	832	29
Class6	-	237,000	102,000	35,200	8,320	293
Class7	-	-	-	352,000	83,200	2,930
Class8	-	-	-	3,520,000	832,000	29,300
Class9	-	-	-	35,200,000	8,320,000	293,000

Britain BS 5295

Classs	Maximum concentration limits (particles/m³ )
Classs	0.5μm	1.0μm	5.0μm	10μm	25μm
Class 1	3,000	-	0	0	0
Class 2	300,000	-	2,000	30	-
Class 3	-	1,000,000	20,000	4,000	300
Class 4	-	-	200,000	40,000	4,000

Worldwide Standard comparison

Worldwide Standard	Class
ISO 14644-1	ISO 3	ISO 4	ISO 5	ISO 6	ISO 7	ISO 8
FS 209E	Class 1	Class 10	Class 100	Class 1000	Class 10000	Class 100000
FS 209E(SI)	M1.5	M2.5	M3.5	M4.5	M5.5	M6.5
JIS B 9920	Class 3	Class 4	Class 5	Class 6	Class 7	Class 8
Britain BS 5295	C	D	E/F	G/H	J	K
Germany VD I.2083	1C	2	3	4	5	6
Australia AS 1386	0.035	0.35	3.5	35	350	3500
France AFNOR X44101	-	-	4,000	-	4,000	4,000,000
Grade	-		A/B	-		C

PIC/S GMP Guide

For the manufacture of sterile medicinal products

The “in operation” and “at rest” states should be defined for each clean room or suite of clean rooms. For the manufacture of sterile medicinal products 4 grades can be distinguished:

Description
Grade A	The local zone for high risk operations, e.g. filling zone, stopper bowls, open ampoules and vials, making aseptic connections. Normally such conditions are provided by a laminar air flow work station. Laminar air flow systems should provide a homogeneous air speed in a range of 0.36 – 0.54 m/s (guidance value) at the working position in open clean room applications. The maintenance of laminarity should be demonstrated and validated. A uni-directional air flow and lower velocities may be used in closed isolators and glove boxes.
Grade B	For aseptic preparation and filling, this is the background environment for the grade A zone.
Grade C	Clean areas for carrying out less critical stages in the manufacture of sterile products

Clean rooms and clean air devices should be classified in accordance with EN ISO 14644-1. Classification should be clearly differentiated from operational process environmental monitoring. The maximum permitted airborne particle concentration for each grade is given in the following table:

Maximum permitted number of particles/m³ equal to or greater than the tabulated size
	At rest		In operation
Grade	0.5μm	5μm	0.5μm	5μm
A	3,500	0	3,500	0
B	3,500	0	3,500	2,000
C	350,000	2,000	350,000	20,000
D	3,500,000	20,000	not defined	not defined

For classification purposes in Grade A zones, a minimum sample volume of 1m³ should be taken per sample location.
For Grade A the airborne particle classification is ISO 4.8 dictated by the limit for particles ≥5.0 μm.
For Grade B (at rest) the airborne particle classification is ISO 5 for both considered particle sizes.
For Grade C (at rest & in operation) the airborne particle classification is ISO 7 and ISO 8 respectively.
For Grade D (at rest) the airborne particle classification is ISO 8.
For classification purposes EN/ISO 14644-1 methodology defines both the minimum number of sample locations and the sample size based on the class limit of the largest considered particle size and the method of evaluation of the data collected.

Examples of operations to be carried out in the various grades are given in the table below :

Grade	Examples of operations for terminally sterilised products
A	Filling of products, when unusually at risk
B	Preparation of solutions, when unusually at risk. Filling of products
D	Preparation of solutions and components for subsequent filling

Grade	Examples of operations for aseptic preparations
A	Aseptic preparation and filling
B	Preparation of solutions to be filtered
D	Handling of components after washing

HEPA Information

EN 1822:2009

Filter Class	Overall Value		Local Value
Filter Class	Efficiency(%)	Penetration(%)	Efficiency(%)	Penetration(%)
E10	≧85	≦15	-	-
E11	≧95	≦5	-	-
E12	≧99.5	≦0.5	-	-
H13	≧99.95	≦0.05	≧99.75	≦0.25
H14	≧99.995	≦0.005	≧99.975	≦0.025
U15	≧99.9995	≦0.0005	≧99.9975	≦0.0025
U16	≧99.99995	≦0.00005	≧99.99975	≦0.00025
U17	≧99.999995	≦0.000005	≧99.9999	≦0.001

EPA 10 - EPA 12: Efficiency Particulate Air Filters
HEPA 13 - HEPA 14: High Efficiency Particulate Air Filters
ULPA 15 - ULPA 17: Ultra Low Penetration Air Filters

DIN EN 779:2012

Group	Class	Final pressure drop (Pa)	Average arrestance (%)	Average efficiency (%)	Minimum efficiency @0.4µm (%)
Coarse dust filter	G1	250	50 ≤Am< 65	-	-
	G2	250	65 ≤ Am< 80	-	-
	G3	250	80 ≤ Am< 90	-	-
	G4	250	90 ≤ Am	-	-
Medium	M5	450	-	40 ≤ Em< 60	-
Medium	M6	450	-	60 ≤ Em< 80	-
Fine dust filter	F7	450	-	80 ≤ Em< 90	35
	F8	450	-	90 ≤ Em< 95	55
	F9	450	-	95 ≤ Em	70

ISO 29463:2011

Filter Class	Overall Value		Local Value
Filter Class	Efficiency(%)	Penetration(%)	Efficiency(%)	Penetration(%)
ISO 15 E	≧95	≦5	-	--
ISO 20 E	≧99	≦1	-	--
ISO 25 E	≧99.5	≦0.5	-	--
ISO 30 E	≧99.90	≦0.1	-	--
ISO 35 H	≧99.95	≦0.05	≧99.75	≦0.25
ISO 40 Hd	≧99.99	≦0.01	≧99.95	≦0.05
ISO 45 Hd	≧99.995	≦0.005	≧99.975	≦0.025
ISO 50 U	≧99.999	≦0.001	≧99.995	≦0.005
ISO 55 U	≧99.999 5	≦0.000 5	≧99.997 5	≦0.002 5
ISO 60 U	≧99.999 9	≦0.000 1	≧99.999 5	≦0.000 5
ISO 65 U	≧99.999 95	≦0.000 05	≧99.999 75	≦0.000 25
ISO 70 U	≧99.999 99	≦0.000 01	≧99.999 9	≦0.000 1
ISO 75 U	≧99.999 995	≦0.000 005	≧99.999 9	≦0.000 1

Please note: These charts provide approximate data regarding various filter classes for reference purposes only. Specific data applicable to an intended application must be determined at the expected face velocity.

Filter Integrity Test

PAO Method

(For testing HEPA) In the PAO test, a gas type of smoke will be generated by the PAO generator. After using the photometer to test the concentration on the upstream of the HEPA, a particle counter will be put at the air exhaust area to test the PAO concentration that passes through HEPA. The distance between the particle counter and HEPA will be around 25mm with testing speed at 50mm/sec. The test range includes HEPA filter and its connecting area. However, there are no related guidelines on the measurement method. Just make sure the whole HEPA covered area are tested for leakage. If there are particles over 0.03 are tested, hold the particle counter for 10 sec and then test.

back and forth at the range of 100mm. Once the particles are less than 0.03, proceed the test.

PAO efficiency (%) = ( 1-particle concentration at the HEPA air exhaust area / particle concentration at the HEPA upstream area ) × 100%.

Colorimetry

(For testing Medium Filter or Bag Filter) This is to test the integrity of the Medium Filter mainly for particle size ≧1μm. There will be the same filter indicator paper at the up/downstream of the filter. After sampling, we calculate the filter integrity based on its transparency variation. Normally the NBS method and ASHRAE method ( 52.1 —92 Standard ) are applied. In 1968年, after modification and consolidation, it is called ASHRAE Efficiency or NBS. Both represent Colorimetry.

Q1：The sampling air volume through the upstream indicator paper.
Q2：The sampling air volume through the downstream indicator paper.
O1：The opacity of the upstream indicator paper with particles on it.
O2：The opacity of the downstream indicator paper with particles on it.
Colorimetry efficiency (%)=( 1- Q1/Q2×Q2/Q1)×100%

Arrestance

(For testing pre-filter) This is to test the efficiency of the pre-filter on larger particles which sizes are ≧5μm.
Normally AFI method (in 1960) and ASHRAE method (52.1—92 Standard) are applied.
It is called ASHRAE Arrestance or AFI. Both represent Arrestance.

Wf：The particle quantity supplied at the upstream of the filter(g)
Wp：The weight of the particles attached on the filter(g)
Arrestance efficiency (%)=( 1- Wp/Wf)×100%

When to conduct Leak test?

HEPA replacement
Machine re-installation
Regular test (at least once a year)

After-sales service

Professional Technique		AIRTECH customer service engineers are all authorized by AIRTECH Japan. We conform to the International Inspection Procedures to make sure we offer the best technique and support.
Strick control		All the test equipment is under regular maintenance and calibration to make sure our quality conforms with International standard.
Main Products		Air shower Air curtain Clean Booth Clean Bench Biological Safety Cabinet Fan Filter Unit Fume Hood H2O2 sterilization Sterility Testing Isolator Pass Box RABS TCC
Test Items		HEPA FILTER Leakage Check Air Velocity and Volume Check Cleanliness Check Vibration Check Illuminance Check Noise Check Airflow Check Differential Pressure gauge Check Power Consumption Check Insulation Resistance Check Operation Check
Immediate support		We have enough stock to make sure we can deliver the spare parts within the short period of time.
Warranty		1.One year after we ship out. 2.If below conditions occur, there will be certain cost. Mal-usage or re-assembly by personnel. Re-installation or damage due to falling or crashing Natural calamities, damage caused by mal-usage on power/voltage Consumables (e.g. Filters) replacement, etc.

Remark 1: Testing items will vary from product type.
Remark 2: The warranty items are only applied in Taiwan.