Hardwall Cleanroom

What’s hardwall cleanroom?
  A hardwall cleanroom is a modular system that uses rigid panels, such as sandwich panels, tempered glass, or plexiglass, as partition walls. These panels are paired with aluminum alloy or SS304 frames to create a controlled clean environment. This type of structure is designed to handle the high airflow and pressure needed to maintain advanced cleanliness levels, such as ISO Class 4 or higher. Hardwall cleanrooms are known for their strength, durability, impact resistance, and ease of cleaning and maintenance.

1.What's modular hardwall cleanroom？
  The modular hardwall  cleanroom is an efficient, flexible, and professional space solution designed to provide highly clean production or research spaces for specific environments. It is usually enclosed by an aluminum alloy frame and acrylic panels or sandwich panels. Compared with soft wall cleanrooms, hard-wall structures withstand higher air pressure, which minimizes the effects of external dirty air on the cleanroom environment.
The purified air system of modular hardwall cleanrooms is usually divided into two categories: recirculation and non-recirculation, both of which can be designed and customized according to your requirements and configuration.

2.Features of hardwall modular cleanroom
Here are the features and advantages of modular hardwall cleanrooms：
(1)Flexibility: it can be installed, dismantled and moved freely, also can be upgraded or re-designed according to the adjustments of clean class and customers’ requirements.

(2) Low cost & quick installation: compared with traditional cleanrooms, modular hardwall cleanroom can be manufactured and installed at lower cost and shorter time.

(3)Independent structure: stand freely without any hanging materials
The design and structure of hardwall modular cleanroom are based on the modularization principle, which means the frame, doors and windows, clean equipment are divided into many parts and designed individually according to the customer demands. All sub-modules are delivered to customer site and assembled quickly, this mode is not only high-efficient and pollution-free, but also the materials can be recycled. Adopted large-area glass windows, the cleanrooms are clean and clear, which is suitable for both production and exhibition purposes. Hard-wall modular cleanrooms provide efficient, flexible, and environmentally friendly clean spaces through modular disassembly and assembly, widely used in fields such as optoelectronics and electronics, supporting high cleanliness environmental requirements.

3.Key points for the design and construction of hardwall cleanrooms
The design points of a hard wall clean room mainly include layout, air purification system, cleanliness and air exchange rate, structural design, material selection, pressure control, auxiliary facilities, control of people and materials, as well as water supply and drainage and air supply devices and power supply. 
(1)Cleanroom Layout‌：Reasonable arrangements are made based on factors such as usage functions, process flow, and logistics organization. Common layouts include linear, circular, and honeycomb layouts.

(2)Clean room air filtration system：Select the airflow form according to the working parameters and production process requirements of the room, such as horizontal laminar air flow, vertical laminar air flow, and turbulent flow.

(3)Cleanliness and Clean room air exchange rate：The cleanliness of a room depends on the air exchange rate per unit time, and the technical parameters of the purification system are determined based on the working industry and production process requirements.

(4)Structural design：To ensure that the airflow is almost undisturbed, structural design is carried out to prevent dust accumulation anywhere in the room.

(5)Material selection：The materials for the ceiling, walls, and floors of the clean room should be resistant to breakage, particles, and almost dust-free, and the actual performance of the materials should be considered based on the working conditions of the room.

(6)Control cleanroom pressure: In order to maintain the cleanliness and prevent contaminated airflow from entering the room, it must maintain positive pressure and set an appropriate pressure gradient according to GMP or other industry standards.

(7)Supporting facilities: Equipping hand sinks, shoe changing stools, hand dryers, disinfectors, etc. which must meet the requirements of the room.

(8)Control of people and materials: People and objects are the main sources of dust in the clean room and must be fully controlled. For example, before entering the clean room, everyone must change into clean clothes and be blown through the air shower room.

(9)Water supply and drainage, air supply and power supply: Provide certain water supply and drainage, air supply and power supply according to the workshop to be operated, which must be easy to use and design.

(10)Emergency Plan
To handle unexpected incidents such as equipment malfunctions, personnel evacuations, or contamination leaks, a cleanroom must have a comprehensive emergency plan in place.
Fault alarm system: Realtime monitoring of various parameters of the clean room to ensure immediate alarm when any abnormal situation occurs.
Emergency Evacuation Routes: Ensure that personnel can evacuate safely during emergencies.
Risk Control: Regularly conduct emergency drills to ensure all employees arefamiliar with the emergency procedures.

In the process of design and construction selection, please pay attention to the comparison between recycling and non-recycling:

  In summary, the design and construction of hardwall cleanrooms need to comprehensively consider safety, functionality, economy, sustainability, as well as specific construction quality control and design technical points, ensuring the efficient operation and product quality of cleanrooms.

4.Cleanliness standards & certification processes for hardwall cleanrooms：
1.The cleanliness standards and certification process for hardwall cleanrooms mainly involve the following aspects:

2.Cleanliness standard & Clean room Cleanliness Level:
(1) The cleanliness standards for hard-wall cleanrooms are usually divided according to the ISO 14644-1 standard, including ISO 5, ISO 6, ISO 7, and ISO 8 levels. Among them, ISO 5 represents the highest level and is suitable for experimental environments that are highly sensitive to particulate matters. The requirements for air cleanliness vary with different experimental needs. For example, the number of particles with a diameter greater than 0.5 microns in ISO Class 5 air is limited to no more than 3520 per cubic meter.

(2) In addition to air cleanliness, hardwall cleanrooms also require precise control of temperature and humidity to ensure the stability and repeatability of experiments. Generally speaking, the temperature is controlled between 20-25℃ and the humidity is controlled between 30% -60%.

A. Cleanroom Testing method‌
(1) The particle count test for clean room methods include laser particle counting method and air sampling method. The former uses a laser beam to irradiate particles in the air and detects the quantity and size distribution of particles with the principle of light scattering. The latter determines the content of particles by extracting air samples and filtering and analyzing them. ‌
(2) Microbial detection methods include air sampling method and surface swab method. The former collects microbial particles in the air and determines the content of microorganisms through cultivation and counting methods, while the latter through surface swabbing samples in the laboratory and cultivation and identification. ‌
(3) The detection of temperature and humidity is usually carried out in real-time by installing temperature and humidity sensors.

B. Certification process:
(1) The certification process for hardwall cleanroom usually includes regular testing of various indicators of the cleanroom to ensure compliance with predetermined cleanliness standards and relevant regulatory requirements.
(2) The testing content includes but doesn't limit to air cleanliness, temperature, humidity, air speed or volume, airflow pattern, etc.
(3) The test results shall be submitted to the corresponding certification agency for evaluation. If all standards and requirements are met, a certification certificate will be obtained.
In summary, the cleanliness standards and certification process for hard-wall cleanrooms involve multiple aspects, including the classification of cleanliness, implementation of testing methods, and completion of the certification process. These measures collectively ensure that the environmental quality of the hard-wall cleanroom meets the specific experimental or production requirements, thereby ensuring product quality and safety.

5.Maintenance & management of hardwall cleanrooms
  To maintain the cleanliness in the hardwall cleanroom, the relevant maintenance regulations must be strictly followed to prevent the generation, retention, and reproduction of dust particles and microorganisms in the cleanroom, and ensuring the safety of equipment and personnel

A.Management of operators in hardwall cleanrooms
â‘  Hands are the medium of cross contamination, operators must wash their hands before entering the cleanroom and avoid touching high purification items and packaging materials with their hands; Disinfection treatment is also required for personnel involved in drug production operations.
â‘¡ The following personnel are not allowed to enter the clean room: patients with colds, coughs, eczema and other diseases; Those who do not wash off cosmetics, nail polish or wear clean work clothes as required; Operators should regularly wash hair, change clothes, and trim nails.
â‘¢ When working in the clean room, the operators should move gently, strictly follow the operating procedures, avoid large movements that are prone to dust, do not drag feet and walk or make unnecessary movements; It is not allowed to go to the washroom when wearing clean work clothes.
â‘£ In the clean room, gloves should be worn as required, without exposing the wrist, and gloves should be changed frequently.
⑤ Relevant training and education should be provided to personnel entering the clean room: mastering the characteristics, structure, and general knowledge of clean technology of the clean room, personnel purification procedures and material purification route requirements, use and cleaning requirements of clean clothes, cleaning, cleansing, and disinfection of the clean room, safety facilities and safety management regulations of the clean room.
â‘¥ Clean clothes should be made of fabric that produces less dust and anti-static. Generally, it is split-style for ISO 7 cleanroom or ISO 8 cleanroomsï¼› and one-piece for ISO 5 cleanroom or ISO 6 cleanrooms. It is best to use disposable clean shoe covers, and clean shoes should be washable.
⑦ Clean clothes should be managed by an assigned person, regularly inspected and cleaned. Generally, it should be cleaned once a week, and after cleaning 50-100 times, it should be checked to determine if discard as useless .

B.Cleaning & disinfection of hardwall cleanrooms
â‘  The cleaning of the clean room generally is carried out after the production process is completed; If it is necessary to clean before the production, the process production must start only after the purification air conditioning system has been running and meet the clean requirements.
â‘¡ To prevent cross contamination, clean room facilities should be classified according to product characteristics, process requirements, and cleanliness levels. Cleaning tools generally are centralized fixed and portable mobile vacuum cleaning equipment. If the above conditions are not met, non fiber shedding materials such as silk cloth or nylon cloth can also be used for wiping, usually once or several times a day. The workbench and tools are usually cleaned once a day. The purification air conditioning system should be cleaned 1-2 times a year and entrusted to specialized cleaning personnel.
â‘¢ In addition, the entire disinfected and sterilized clean room should be in a circulating state through the return air duct, and air sterilization should be done for 1-1.5 hours every day when the machine is turned on; If it is necessary to disinfect and sterilize the walls, floors, and equipment surfaces of the clean room, it takes about 2 hours.
â‘£ When using efficient vacuum cleaner, it is necessary to regularly check the dust concentration at the exhaust port of the vacuum cleaner.

C.Maintenance of major equipment
  Conditions for replacing high-efficiency filters:
â‘  The airflow speed is reduced to the minimum, and even after replacing the primary and secondary air filters, it cannot be increased.
â‘¡ The resistance of the high-efficiency filter reaches twice of the initial.
â‘¢ The high-efficiency filter has irreparable leakage.
â‘£ Suggest replacing once a year
Risk control: Periodically test the effectiveness of filter and air flow patterns to prevent filter failure or air short circuit, resulting in the accumulation of pollutants in the clean room.

6.Introduction of AIRKEY modular hardwall cleanrooms
 

7.What industries are hard wall cleanrooms suitable for?
Suitable industries include but are not limited to:
  Electronic information industry, pharmaceutical and biotechnology industry, aerospace and defense industry, new energy industry, precision instruments and optics industry, food and beverage industry, laboratories and research institutions, and new material research and development. 
  Hardwall cleanrooms, as a special production environment, are designed and constructed to control pollutants such as particles and microorganisms in the air to ensure high purity and performance of products. Specifically, the demand for clean rooms in these industries is as follows:
â‘  Electronic information industry: including integrated circuits, semiconductors, optoelectronics, flat panel displays, etc. These industries are very sensitive to dust particles on the surface of products, and electronics cleanroom can ensure high purity and high performance of products.
â‘¡ Pharmaceutical and biotechnology industries: used in pharmaceuticals, vaccine production, genetic engineering, bio-pharmaceuticals, etc. Pharmaceutical cleanroom and biotech cleanroom prevent cross contamination and ensure the safety and effectiveness of products.
â‘¢ Aerospace and defense industries: used for manufacturing high-precision instruments, sensors, satellites, missiles, etc. The aerospace cleanroom environment ensures the accuracy and reliability of products.
â‘£ New energy industry, such as solar cells, fuel cells, lithium batteries, etc., clean rooms help to improve the electrical performance and stability of materials.
⑤ Precision instruments and optical industry: used for producing microscopes, telescopes, precision measuring instruments, etc. Cleanrooms reduce the impact of particles in the air on optical systems.
â‘¥ Food and beverage industry: used for producing high cleanliness food and beverages, clean rooms prevent products from contamination.
⑦ Laboratories and research institutions: used for conducting various scientific experiments, lab cleanroom provide a stable and controllable experimental environment.
⑧ New material research and development: such as carbon nanotubes, nanomaterials, etc. The clean room environment is crucial for ensuring the purity and performance of materials.