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Class 100,000 Cleanroom

lass 100,000 Cleanroom

To meet customers’ requirements

for product production environments—especially customers in the medical industry

DOIT has built a Class 100,000 cleanroom in line with the international ISO 14644 standard.

What is a Class 100,000 Cleanroom?

A Class 100,000 cleanroom is also called "Class 100,000 Cleanroom". It is a type of cleanroom classification standard. It means that in each cubic foot of air, the number of suspended particles with a diameter of ≥ 0.5 microns is controlled within 100,000.?

This level of cleanroom is usually used in industrial fields. These fields need cleanliness, but they are not extremely sensitive to it. This cleanroom uses a series of comprehensive measures to control things in the air. The measures include HVAC systems, building enclosures, personnel and material flow control, and so on. The things to control are particles, harmful air, temperature, humidity and air pressure. By doing this, it can provide a stable and controllable production environment.

Core Standards and Key Parameters?

Cleanliness Level	1、There is the ISO 14644-1 Standard. It corresponds to ISO Class 8.? 2、There is also the Federal Standard 209E. This standard has been abolished, but it is still widely used in the industry. It is called Class 100,000 under this standard.? 3、Particle Count:?The number of particles that are ≥ 0.5μm is two options. One option is ≤ 3,520,000 per cubic meter. The other option is ≤ 100,000 per cubic foot.?
Temperature and Humidity Control	1、First is Temperature. It is usually controlled at 22±2°C. And it can be adjusted. The adjustment is based on process needs.? 2、Then is Relative Humidity. It is usually controlled at 55±5% RH. This control is to prevent products from absorbing moisture. It also helps prevent products from oxidizing. Besides, it stops products from accumulating static electricity.?
Pressure Difference Control	1、The inside of the cleanroom must maintain a positive pressure state. That means the indoor air pressure is higher than the outdoor air pressure.? 2、The pressure difference is usually kept at 10-15 Pa.? 3、There is a purpose for this pressure control. It is to prevent unfiltered external air from entering the clean area. The air might enter through gaps in doors and windows. If it enters, it will pollute the internal environment.?
Air Change Rate	1、A Class 100,000 cleanroom usually has a requirement. The requirement is an air change rate of 15-25 times per hour.? 2、2、To meet this requirement, a large amount of clean air is used. This clean air is filtered by high-efficiency filters. It is used to continuously dilute particles in the room. These particles are generated inside the room. And it also removes these particles.?
Illumination and Noise	1、First is Illumination. It needs to be ≥300 Lux. This is to ensure the work area has sufficient light.? 2、Then is Noise. It needs to be ≤65 dB (A). This is to provide a working environment that is relatively comfortable.

Application Fields

Class 100,000 cleanrooms are widely used in industries that require medium-level cleanliness, including but not limited to:

-Medical Silicone Products:? ?Sterile medical device silicone products such as syringes, infusion tubes and catheters.

-Precision Manufacturing:? ?Sealing rings for optical lenses.

-Maternity and Baby Products: Baby pacifiers, one-way valves for breast pumps, etc.

Core Composition and Infrastructure?

A standard Class 100,000 cleanroom is usually made up of the following systems:?

? ? ? ? Enclosure Structure

First is Panels. Color steel plates are used. These plates have cores. The cores can be rock wool, magnesium oxide or paper honeycomb. These plates have some characteristics. They are smooth. They do not generate dust. They are easy to clean. And they are fire-resistant.?

Then is Doors and Windows. Special clean airtight doors are used. Aluminum alloy fixed windows are also used. This is to ensure air tightness.?

Air Purification System (HVAC)

-This system is the core of the cleanroom.?

-First is the Combined Air Handling Unit (AHU). It has primary filters (G4). It also has medium-efficiency filters (F8/F9). These filters are used for pre-treating air.?

-Second is the High-Efficiency Particulate Air (HEPA) Filter. It is installed at the end of the air supply. The air supply end can be the ceiling FFU or the duct end. Its filtration efficiency is 99.97%-99.99% @ 0.3μm. It is a key equipment. This equipment is used to ensure cleanliness.?

-Third is the Air Supply and Return System. Air is supplied from the top FFU. Then air is returned from the floor or side wall. This forms a stable air flow pattern. Usually, this pattern is turbulent flow.?

Personnel and Material Purification System

-First is the Air Shower/Transfer Window. It is a channel. Materials use this channel to enter the clean area. It is used for transferring small materials. This is to avoid pollution. The pollution would happen if people open the main door.?

-Second is the Changing Room. People change clothes step by step here. The steps are first change and second change. The room is equipped with clean wardrobes. It also has hand washing basins, dryers and hand disinfectors. Personnel must wear clean clothes. They also need to wear hats, masks, gloves and clean shoes.?

Other Auxiliary Systems

-First is the Lighting System. Special clean lamps are used here. These lamps are installed in an embedded way. And they are easy to clean.?

-Second is the Floor. Epoxy self-leveling floor is used. It has some features. It is wear-resistant. It is anti-static. It has no seams. And it is easy to clean.?

-Third is the Monitoring System. It does real-time monitoring. It also does real-time recording. The things it monitors and records are temperature, humidity, pressure difference and cleanliness.?

Operation and Maintenance Management?

Hardware facilities alone are not enough. They cannot maintain cleanliness. Strict management procedures are very important. Here are the details:?

①Personnel Training: All personnel need to enter the cleanroom. These people must receive training. The training is about cleanroom code of conduct. For example, how to change clothes, how to move, no running, no loud talking and so on.?

②Cleaning and Disinfection: People need to develop strict cleaning SOPs. They use special dust-free tools. They also use special dust-free reagents. They clean and disinfect walls, floors and equipment surfaces regularly.?

③Daily Monitoring: People do particle counting regularly. They also do microbial sampling regularly. The sampling includes planktonic bacteria and sedimentary bacteria. They do pressure difference testing regularly. And they do temperature-humidity testing regularly. They keep records of all these tests.?

④Equipment Maintenance: People replace primary and medium-efficiency filters regularly. They also test the resistance of HEPA filters regularly. And they test the integrity of HEPA filters regularly.

A Class 100,000 cleanroom is an indispensable infrastructure in modern manufacturing—especially in fields such as medical care, food and precision manufacturing. It uses a combination of hardware investment (purification systems, enclosure structures) and software management (standard procedures, personnel operations) to effectively control the production environment. Finally, it achieves the core goals of ensuring product quality, improving yield and meeting regulatory requirements. Its construction and operation is a systematic project involving multiple professions and requiring continuous maintenance.

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