Softwall Cleanroom

1.What is the softwall cleanroom?
  Softwall cleanroom is a modular cleanroom that is made of transparent or opaque flexible panels installed on a solid steel frame to form an enclosed clean area. ‌This cleanroom is light in weight, highly adaptable, easy to install and maintain, and cost-effective, and can be easily assembled and adjusted according to needs.
  Softwall cleanrooms are available in fixed and mobile types. They can be supplied as a set for easy movement, disassembly, and storage. The airflow organization pushes the air downward through the cleanroom through positive airflow, allowing particles to be washed away through low-level exhaust ports. It is more suitable for applications where the clean area is frequently changed or expanded, and it flexibly provides the necessary environmental control to ensure the cleanliness of the production process and product quality.

2. Features of softwall cleanroom:
  Modular softwall cleanrooms are designed to achieve functionality and reduce costs, and have the following main features:
â—†Easy installation: Softwall cleanrooms adopt modular design, and will be prefabricated before shipment to ensure that the construction site can be quickly assembled and disassembled, greatly reducing the construction cycle, which is very suitable for occasions where the working environment is temporarily or frequently changed.
â—†High flexibility: The size and shape of the cleanroom can be adjusted according to different product production requirements and the actual environmental conditions on site to meet different work needs.
â—†Easy to reconfigure and expand: The modular clean room design of the softwall cleanroom can be quickly and easily reconfigured and expanded without dismantling the entire cleanroom, providing a fast and efficient solution for production in various industries.
â—†High cost-effectiveness: Compared with fixed soft-wall cleanrooms, soft-wall cleanrooms can accurately match the space and cleanliness requirements required for production, reduce the construction and movement costs of cleanrooms, and are particularly suitable for users with limited budgets or temporary needs.
â—†Easy to clean and maintain the structure: The softwall cleanroom is composed of transparent or opaque panels with a smooth surface that is not easy to absorb dust and dirt, making it easy to clean and maintain.
â—†Cleanliness adaptability: Different levels of cleanliness can be designed to meet the cleanliness requirements of different industries.
â—†Regular inspection and maintenance: When the structural cleaning work is sufficient, the soft-wall clean room also needs to regularly inspect and replace the clean room's filtration system to ensure the stability of the clean room.

3.Key points in design and construction of softwall clean rooms:
  The key points of modular cleanroom design mainly include structure, airflow organization, cleanliness, temperature and humidity control, material selection, pressure difference control, purification equipment, intelligent management, construction acceptance and maintenance to ensure efficient operation of the cleanroom and meet the needs of different industries. 

(1) Cleanroom structure & Cleanroom layout: Soft-wall cleanrooms usually adopt an assembled structure design, which is easy to install and move, and are reasonably arranged according to factors such as usage function, process flow and logistics organization to ensure that each area does not interfere with each other and reduce cross contamination.

(2) Airflow organization: According to the cleanliness requirements, a reasonable air supply and return air system is designed to ensure uniform distribution of indoor airflow and effectively filter particles in the air.

(3) Cleanliness: According to industry standards, set and maintain the required clean room cleanliness level, such as ISO 4, ISO 5, ISO 6, ISO 7, ISO 8, etc., through high-efficiency filters and regular maintenance.

(4) Temperature and humidity control: According to different production needs, configure a suitable air conditioning system to accurately control indoor temperature and humidity to provide stable environmental conditions for the production process.

(5) Material selection: The materials of the clean room ceiling, wall and floor should not be easy to break, not easy to be stained with particles, and almost dust-free. The actual performance of the materials should be considered according to the working conditions of the room.

(6) Control cleanroom pressure: In order to maintain the cleanliness of the room and prevent the outside polluted air from entering the room, the room must maintain positive pressure and set a suitable pressure gradient according to GMP or other industry standards.

(7) Purification equipment: Deploy wash basins, shoe benches, hand dryers and disinfectors, etc. These facilities must meet the requirements of the room.

(8) Intelligent management: Install sensors and intelligent control systems such as temperature, humidity, pressure difference, and dust particles to monitor and adjust indoor environmental parameters in real time and improve management efficiency.

(9) Construction and acceptance: Strictly abide by the specifications during the construction process to ensure the quality of construction; conduct comprehensive acceptance tests after the construction is completed to ensure that all indicators meet the design requirements.

(10) Maintenance and care: Develop a detailed maintenance and care plan, clean, disinfect and inspect the clean room regularly to ensure its long-term stable operation.

  In summary, the design of modular softwall cleanrooms needs to consider the requirements of the above aspects at the same time. In the actual design process, comprehensive consideration should also be given to actual production needs and site conditions to ensure that the clean room can meet the production process requirements and have good safety, comfort and environmental protection.

4.Cleanliness standard and certification process for soft-wall clean rooms:
  The cleanliness standard and certification process of soft-wall clean rooms mainly involve the following aspects: 

（1）The cleanliness standards of soft-wall cleanrooms are usually divided according to the ISO 14644-1 standard, including ISO 5, ISO 6, ISO 7 and ISO 8 grades. Among them, ISO 5 represents the highest level of cleanliness and is suitable for experimental environments that are highly sensitive to particulate matter. Air cleanliness requirements vary according to different experimental needs. For example, the number of particles with a diameter greater than 0.5 microns in ISO 5 air is limited to no more than 3,520 per cubic meter.

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

 Detection methods:
(1) Particle count test for clean room methods include laser particle counting and air sampling. The former uses a laser beam to illuminate the particles in the air and uses the principle of light scattering to detect the number and size distribution of particles. The latter extracts air samples and determines the content of particles after filtering and analysis. 

(2) Microbial detection methods include air sampling and surface swab methods. The former collects microbial particles in the air and determines the content of microorganisms through culture and counting methods. The latter swabs samples from the surface in the laboratory and determines the contamination of microorganisms through culture and identification. 

(3) Temperature and humidity detection is usually carried out by installing temperature and humidity sensors for real-time monitoring.

Certification process:
(1) The certification process of soft-wall cleanrooms usually includes regular testing of various indicators of the cleanroom to ensure compliance with the predetermined cleanliness standards and relevant regulatory requirements.

(2) The test content includes but is not limited to air cleanliness level, temperature, humidity, wind speed or air volume, air flow pattern, etc.

(3) The test results need to be submitted to a certification body with corresponding qualifications for evaluation. If all standards and requirements are met, a certification certificate will be obtained.

  In summary, the cleanliness standards and certification process of soft-wall cleanrooms involve multiple aspects, including the classification of cleanliness levels, the implementation of testing methods, and the completion of the certification process. These measures together ensure that the environmental quality of the soft-wall cleanroom meets the needs of specific experiments or production, thereby ensuring product quality and safety.

5.Maintenance and management of softwall cleanrooms:
  In order to maintain the air cleanliness in the softwall cleanroom, relevant maintenance regulations must be strictly implemented to prevent the generation, retention and reproduction of dust particles and microorganisms in the clean room and ensure the safety of equipment and personnel.

A Management of workers in softwall cleanrooms   
（1） Hands are the medium of cross-contamination. Workers entering the clean room must wash their hands and do not touch high-purity items and high-purity packaging materials with their hands; workers in pharmaceutical production also need to be disinfected.

（2） The following people 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 and do not wear clean work clothes as required; workers should wash their hair, change clothes and cut their nails frequently.

（3） When working in the clean room, workers should move lightly, strictly follow the operating procedures, do not make large movements that are easy to generate dust, do not drag their feet when walking, and do not make unnecessary movements; it is not allowed to wear clean work clothes to go to the toilet.

（4）  In the clean room, gloves must be worn as required, do not expose your wrists, and gloves must be changed frequently.

（5）  Relevant training and education should be carried out for personnel entering the clean room: master the characteristics, structure, general knowledge of clean technology of the clean room, personnel purification procedures and material purification route requirements, the use and cleaning requirements of clean work clothes, the cleaning, cleaning and disinfection of the clean room, and the safety facilities and safety management regulations of the clean room.

（6） Clean work clothes should be made of low-dust and anti-static materials. Generally, the Class 100,00 cleanroom - Class 100,000 cleanrooms use the split type, and the Class 100 cleanrooms - Class 1000 cleanrooms use the one-piece type. It is best to use disposable clean shoe covers, and clean shoes are required to be washable.

（7）  Clean work clothes should be managed by a dedicated person, checked and cleaned regularly. Generally, they should be cleaned once a week, and usually after 50-100 times of cleaning, they should be checked to determine whether they are scrapped.

B. Cleaning and sterilization of softwall cleanrooms 
(1) Cleaning of clean rooms should generally be carried out after the production process is completed; if it is necessary to clean before production, the process production must be started after the purification air conditioning system has been turned on and running for a period of time that meets the cleanliness requirements.

(2) To prevent cross-contamination, the facilities for cleaning clean rooms should be dedicated to the product characteristics, process requirements, and cleanliness levels. Cleaning tools generally use centralized fixed and portable mobile vacuum cleaning equipment. If the above conditions are not met, fiber-free materials such as mercerized towels and nylon cloths can also be used for wiping, generally once or several times a day. Workbenches and tools are generally cleaned once a day. The purification air conditioning system should be cleaned 1 to 2 times a year and entrusted to special cleaning personnel.

(3) In addition, the entire clean room to be disinfected and sterilized should be circulated through the return air duct, and the air should be turned on for 1-1.5 hours a day for air sterilization; if the clean room walls, floors, equipment and other surfaces need to be disinfected and sterilized, it will take about 2 hours.

(4) When using a high-efficiency vacuum cleaner to clean a clean room, the dust concentration at the vacuum cleaner exhaust port must be checked regularly.

C. Maintenance of main equipment 
1. Conditions for replacing high-efficiency filters:
a. The air flow rate is reduced to the minimum. Even after replacing the primary and medium-efficiency air filters, the air flow rate still cannot be increased.
b. The resistance of the high-efficiency filter reaches twice the initial resistance.
c. The high-efficiency filter has an irreparable leak.
d. It is recommended to replace it once a year.

6.Introduction to the characteristics of AIRKEY's soft-wall clean room: 
 

7.Choice between hardwall and softwall cleanrooms:
(1) Production process and environmental requirements: Evaluate the specific production needs of the project, including the required cleanliness, the types of pollutants to be controlled, and the environmental conditions to be maintained, and determine whether a hardwall cleanroom or a softwall cleanroom with strict control is required.

(2) Cost budget: Determine budget constraints and evaluate the cost-effectiveness of each type. Soft-wall cleanrooms tend to be more affordable and faster to build, while hardwall cleanrooms have superior durability and control capabilities.

(3) Scalability: Anticipate whether the cleanroom will need to be reconfigured or expanded in the future. The modular design of soft-wall cleanrooms makes it easier to move, disassemble, and store. In contrast, hard-wall cleanrooms provide a more durable and sturdy structure.

8.Which industries are soft wall clean rooms suitable for:
  Softwall cleanrooms have unique characteristics compared to hardwall cleanrooms. They are mainly used to quickly and easily establish a local high-cleanliness environment. In terms of application, softwall cleanrooms are widely used in places that require a local high-cleanliness environment. The following are some common application industries:
(1) Pharmaceutical and bioengineering: Softwall cleanrooms accurately control the pollution of living and inanimate particles and are suitable for places such as the pharmaceutical industry, hospital operating rooms, and sterile wards.

(2) Precision machinery industry: Softwall cleanrooms are used to control inanimate particles and minimize the pollution of air dust particles on work objects. They are suitable for the production of semiconductors and integrated circuits.

(3) Electronics industry: Softwall cleanrooms are used to prevent dust from affecting products and are suitable for the production of liquid crystal glass, computer hard drives, computer heads, and other products.

(4) Medical device manufacturing: Softwall cleanrooms ensure the cleanliness of the production environment and are suitable for the decoration and purification of medical device dust-free workshops.

In addition, softwall cleanrooms are also used in food processing, cosmetics production and other fields to ensure food safety and hygiene. Including the decoration of medical device dust-free workshops and the purification of electronic component production workshops.