Elaboration on ISO8/Class 100000 Cleanroom

What is an ISO8/Class 100000 Cleanroom?

  ISO 8 cleanroom (also known as a Class 100,000 cleanroom) is a clean environment classified according to the ISO 14644-1 standard by the International Organization for Standardization (ISO). This level of cleanroom requires that the number of particles with a diameter of 0.5 microns or larger does not exceed 352,000 particles per cubic meter of air, and the number of particles with a diameter of 5 microns or larger does not exceed 832,000 particles per cubic meter of air.

  ISO 14644-1 Standard for airborne particles in clean area:

From the table above, in an ISO 8 cleanroom, the concentration of airborne particles per cubic meter of air must not exceed:
3,520,000 particles with a diameter ≥ 0.5 μm;
832,000 particles with a diameter ≥ 1.0 μm;
29,300 particles with a diameter ≥ 5.0 μm.
For particles with a diameter less than 0.5 μm, there are no specified limits in an ISO 8 cleanroom because such particles have minimal impact on the production activities within the cleanroom.

Cleanroom State:
  There are three different states for a cleanroom, and the design of an ISO8 cleanroom requires to confirm which state to reach ISO 8 standard (this will affect the selection of purification system). The three states are as follows:
  ►As-built: the cleanroom has been constructed and powered on, but no production equipment, materials or personnel are present.
  ►At-rest: The cleanroom has been built, the production equipment has been installed and is operating in a manner agreed to by the user and supplier, but no personnel are present.
  ►Operational: The cleanroom is operating in a defined manner, with a defined number of personnel present and working in a mutually agreeable manner.

  The particle cleanliness of the air in a Cleanroom or Clean Area shall be defined in terms of one or three of the three states: "As-built", "At-rest" and "Operational".
  "As-built" applies to newly constructed or released Cleanroom or Clean Areas. Once the testing on the "As-built" has been completed, the "At-rest" or "Operational" or both states should be further tested.

There are three different types of ISO 8/Class 100000 cleanrooms:
1. Traditional stick-built ISO 8 Cleanroom
2. Modular Hardwall ISO 8 Cleanroom (including acrylic hardwall and sandwich panel hardwall)
3. Modular Softwall ISO 8 Cleanroom

ISO 8/Class 100000 Hardwall Cleanrooms are divided into two categories:
Acrylic Wall Cleanroom and Sandwich panel Wall Cleanroom, both free-standing, no need extra suspension. They can maintain a stable positive pressure inside, and the cleanliness level can be determined according to specific requirements.

Characteristics:
1. Frame: The frame of a modular hardwall cleanroom can be made of stainless steel or aluminum alloy. Stainless steel is corrosion-resistant with high strength, while aluminum is easy to install, lightweight and has an outstanding appearance.
2. Ceiling: Aluminum-plastic panels are of high quality, lightweight, and easy to install.
3. Walls: Transparent acrylic panels are strong and cost-effective. Anti-static acrylic panels have anti-static properties on the surface, making them suitable for cleanrooms that require an anti-static environment. Color steel panels are dust-proof and durable.
4. FFU (Fan Filter Units): High-quality, energy-efficient, low-noise fans are used, or fans specified by the customer, such as those from Germany's brand EBM. The casing is made of aluminized zinc plate or stainless steel.
5. Control System: The control system, developed by AIRKEY, uses PLC to uniformly control FFUs, adjusting wind speed, pressure difference, and temperature and humidity (if equipped with air conditioning).

Advantages of ISO 8/Class 100000 Modular Cleanrooms:
1. Flexibility: Modular cleanrooms can be assembled, disassembled, and relocated. They can be reconfigured or upgraded as cleanliness or requirements change.
2. Cost-effective and Fast Installation: Compared to traditional cleanrooms, modular cleanrooms can be produced and assembled in a shorter period of time and at a lower cost.
3. Free-standing Structure: Modular cleanrooms can stand independently without the need for suspension from the roof.

Layout Requirements for ISO 8/Class 100000 Cleanrooms:
1.The layout should be reasonable and compact. Only necessary process equipment and operations requiring air cleanliness should be placed within the cleanroom or clean zone.
2.Cleanrooms or clean zones with strict air cleanliness requirements should be located near air handling units, and processes and workrooms with the same cleanliness level should be grouped together, provided that production process and noise requirements are met.
3.Processes requiring strict air cleanliness should be located on the upwind side within the cleanroom, while equipment prone to generating contamination should be positioned near the return air vents.
4.The transportation route for the installation and maintenance of large equipment should be considered, and equipment installation openings and maintenance openings should be reserved.
5.When frequent interaction occurs between rooms of different cleanliness levels, contamination prevention measures such as airlocks and pass box should be implemented.
6. Separate material inlet should be designed and material transfer route should be as short as possible. Materials should be cleaned before entering into the cleanroom.

Personnel and Material Purification Principles for ISO 8/Class 100000 Cleanrooms:
1.Measures for shoe cleaning should be set up at the entrance of personnel purification rooms.
2.Separate rooms should be provided for storing outer garments and changing into cleanroom garments.
3.Outer garment lockers should be provided for each person based on the design capacity, while cleanroom garments should be centrally hung in clean cabinets with air showers.
4.Washrooms should be equipped with hand-washing and drying facilities.
5.Air shower room should be installed at the entrance to the clean zone and adjacent to the cleanroom garment changing area. One single-person air shower should be provided for every 30 people based on the maximum shift size. If there are more than five personnel in the clean zone, a bypass door should be provided on one side of the air shower.
6.Toilets should not be located within the clean zone. If toilets are provided in personnel purification rooms, they should have a anteroom.

Partition walls for ISO 8/Class 100000 Cleanrooms:
Material Selection: Walls and floors should be made of non-porous materials to minimize particle generation and facilitate cleaning.
Smooth surface: Walls and floors must have smooth surfaces to prevent particle accumulation and enhance cleaning efficiency.
Antimicrobial properties: Walls and floors may need antimicrobial properties to reduce microbial growth.
Additional Requirements for Walls and Ceilings:
1.The surfaces of walls and ceilings should be smooth, flat, dust-free, glare-free, easy to clean, and should minimize the presence of protrusions and recesses.
2.Kick-plate should not protrude from the wall surface.
3.Masonry walls with plaster surfaces are not recommended for cleanrooms.

  AIRKEY's hardwall modular cleanrooms use lightweight sandwich panel walls, which are antimicrobial, durable, and easy to install. They offer quick assembly and a reuse rate of nearly 100%, making our product your best choice!
Cleanroom Floor Design Requirements:
1. The floor of the cleanroom should meet the production process requirements.
2. The floor should be flat, wear-resistant, easy to clean, crack-free, and not prone to static electricity buildup.
3. The floor base layer should ideally be reinforced, and in humid areas, moisture-proof measures should be taken.
In summary, such floors are generally anti-static PVC flooring or anti-static epoxy self-leveling flooring. AIRKEY can provide customized options according to customer requirements!

Door and Window Requirements for ISO 8/Class 100000 Cleanrooms:
1. When cleanrooms (zones) and personnel purification rooms are equipped with exterior windows, double-glazed fixed windows with good airtightness should be used.
2. Cleanroom windows should be flush with the interior wall surface and should not have window sills.
3. The airtight doors within cleanrooms should open towards rooms with higher air cleanliness levels and should be equipped with door closer. Airtight doors in windowless cleanrooms should have observation windows.

Temperature and Humidity Requirements for ISO 8/Class 100000 Cleanrooms:

Pressure Differential Control Requirements for ISO 8/Class 100000 Cleanrooms:
1. Cleanrooms (zones) must maintain a certain pressure differential related to surrounding spaces and should maintain either a positive or negative pressure differential according to process requirements.
2. The pressure differential between cleanrooms of different cleanliness levels should not be less than 5 Pa. The pressure differential between clean zones and non-clean zones should not be less than 5 Pa, and the pressure differential between clean zones and the outdoors should not be less than 10 Pa.

Airflow Pattern and Air Supply Requirements for ISO 8/Class 100000 Cleanrooms:
1. The airflow pattern in ISO 8 cleanrooms is non-unidirectional, also known as turbulent flow cleanrooms.
2. The airflow in clean zones should be as uniform as possible.
3. The airflow velocity in clean zones should meet the production process requirements, with the velocity of high-efficiency air supply outlets typically controlled between 0.2 and 0.4 m/s.
4. The air supply to clean zones should be determined by comparing the air volume needed to meet the cleanliness level requirements or the air volume needed to handle the thermal and moisture load, whichever is higher.
5. The air change rate for purification air supply in clean zones is typically 15-20 t/h.

Purification System Requirements for ISO 8/Class 100000 Cleanrooms:
1. The purification system for ISO 8 cleanrooms typically features a three-stage filtration setup: G4 pre-filters and F8 medium filters are generally installed within the purification air conditioning unit, while H14 high-efficiency filters are usually placed at the terminal air supply outlets in the room.
2. Air filtration acts as the frontline defender in the ongoing battle against contaminants within cleanrooms. Tasked with purifying every breath, the filtration system serves as the gatekeeper, intercepting particles that could compromise the pristine environment. Strategically placed complex filters in these controlled spaces capture not only visible dust but also microscopic impurities.

HVAC System for ISO 8/Class 100000 Cleanrooms:
1. The HVAC system is used to regulate the temperature, humidity, and airflow of the cleanroom.
2. HVAC systems are the unsung heroes of cleanrooms, silently controlling highly precise environments. In these sterile havens, even the smallest particle can disrupt processes, and HVAC systems play a pivotal role in maintaining optimal conditions. These systems do more than control temperature; they filter and regulate air quality, ensuring a continuous flow of clean air and eliminating contaminants.
3. The design of HVAC settings in cleanrooms is crucial for maintaining strict standards. From controlling humidity to managing airflow patterns, these systems protect the integrity of sensitive operations across industries such as pharmaceuticals, electronics, and healthcare.

Cleanliness Testing for ISO 8/Class 100000 Cleanrooms:
  To determine whether a cleanroom meets the ISO7 cleanroom standard requires documentation about test conditions and results as per specified test procedures.
  Cleanliness test can be performed by using discrete particle counting and light scattering instruments to determine the concentration of suspended particles higher than or equal to a specified particle size at a given sampling point. 
  A discrete particle counter is a light scattering device with the ability to display or record the number and size of discrete particles in the air and the ability to discriminate between particle sizes, to detect the total particle concentration within the appropriate size range for the level being measured, and the appropriate sampling system.
  Before the test, the cleanroom or clean area should be certified as an operational whole, complete and functioning properly in accordance with technical performance requirements.
  Pretest work generally includes:
►Airflow or flow rate test;
►Differential air pressure test;
►Enclosure Leakage Test;
►Integrity Test of the installed filters.

  Determine the location of sampling points: The minimum number of sampling points in an ISO7 cleanroom can be calculated according to the following formula:

  NL —Minimum number of sampling points (rounded to the nearest whole number).
  A - Area of clean room or clean area, measured in square meters.

Notes:
1) Ensure the sampling points are evenly distributed throughout the cleanroom or clean area and are located at the height of the working area.
2) Each sampling point should have at least 2 liters sampling volume and the minimum sampling time is 1 minute.
3) The sampling probe should be inserted into the airflow. If the direction of the air being sampled is uncontrolled or unpredictable (e.g., non-laminar flow), the inlet of the sampling probe should point vertically upwards.
4) When only one sampling point is required, samples should be taken at that point for at least three times.

Recording Results:
Record the concentration of each considered particle size in relation to the air cleanliness class as a result of each sampling measurement, and when only one sampling point is used, calculate and record the average of the sampling data for each considered particle size.
When more than 1 and less than 10 points were sampled, the mean, standard error, and upper 95% confidence limit were calculated from the average particle concentration from all the points.
When there is only one sampling point, or more than nine, the upper 95% confidence limit does not have to be calculated.
If the average value of particle concentration measured at each sampling point and the calculated upper 95% confidence limit does not exceed the ISO7 cleanroom particle concentration limit, the cleanroom or clean area is considered to have achieved the ISO Class7 air cleanliness level, and can meet the corresponding process and production requirements.

ISO8/ Class 100000 Cleanroom Applications:
ISO 8 cleanrooms are widely used in many industries and play an important role in production safety! Industries that typically use these kind of cleanroom are:
- Electronics （electronic cleanroom）
- Optical Manufacturing （optical cleanroom）
- Pharmaceuticals （pharmacy clean room）
- Food/Cosmetics  (food processing clean room)
- Aerospace (aerospace cleanroom)
- Medical Devices  (medical clean room)
- Biology (biotech cleanroom

Advantages of ISO 8/Class 100000 Cleanrooms:
Due to their easy maintenance and simple installation, ISO 8/Class 100000 hardwall modular cleanrooms are becoming increasingly popular across various industries. They can be installed quickly and easily, and then modified or relocated with minimal cost and downtime. The materials used in prefabricated modular cleanrooms are almost 100% reusable.