Number of views: 6176 Author: Aili Industry Release time: 2026-10-07 Source: Ai Li Industrial
During factory renovations, file changes, or customer reviews, we often encounter the label '100,000-level'. Some people think that changing '100,000 level' to 'ISO 8' will complete the update.
In doing so, only the text replacement was completed, but the technical conditions were not updated.
Class 100,000 is the traditional expression of cleanliness level, which usually corresponds to ISO 8 when comparing the particle concentration of no less than 0.5μm. However, the 100,000 level in the original document often only contains the name of the level, without indicating the measured particle size, operating status, regional boundaries and sampling methods. If you only change the name during the update, these missing technical conditions will still be missing.
The correct approach is to handle name conversion and technical condition verification separately. First confirm the complete definition of the original document, and then combine the current standards and actual working conditions to form an acceptable new expression.
The '100,000-level' in old documents may appear in design instructions, process documents, acceptance records or procurement technical agreements. The meaning of level 100,000 in different documents may not be exactly the same.
The 100,000 level in the design description usually describes the design goal and may correspond to static conditions.
The 100,000 level in the process file may correspond to the requirements under production status and is closer to dynamic conditions.
The 100,000 level in the acceptance record records the actual status and method during the test that year.
If we directly change the 100,000 level in these documents to ISO 8 without distinguishing the applicable status of each, it will still be unclear during subsequent audits.
When updating, it is recommended to list in the technical description: adoption standards, evaluation status, measured particle size, and area boundaries. Check and indicate the different calibers of the original documents respectively.
The grade requirements in the old documents were based on the process and equipment conditions of that year. Now those conditions may have changed.
Area use changes . The original storage area has been converted into an assembly area, and the personnel density, equipment heat generation and dust production may be different. For the same ISO 8 label, the corresponding air supply requirements may be different.
Device layout changes . The addition of large-scale equipment or the adjustment of the production line layout may affect the airflow organization and return air path. The original air supply solution may not still be applicable.
Changes in the flow of personnel and materials . The frequency of door opening, the number of personnel, and the method of material entry and exit will all affect the actual particle load. These factors may not be reflected in the old documents.
When updating the level description, it is recommended to confirm the changes in these usage scenarios simultaneously. If you only change the name without checking the actual requirements, the equipment configuration and acceptance conditions may not match.
When updating files, it is easy to mix two things: filtration efficiency and cleanliness level.
ISO 8, which corresponds to the 100,000 level, evaluates the particle concentration in space. Filter efficiency evaluates the product’s capture ability under specified conditions. The two are related, but cannot be directly converted.
The original 100,000-level filter may have used a certain level of filter. If you only check the filter grade during the update without checking the air supply volume, airflow organization and sealing status, the space grade may still not meet the standards.
What is the difference between cleanliness level and filtration efficiency has a more detailed explanation of these two types of indicators. When updating files, filter information and space test reports should be recorded separately.
After the name update is completed, the device configuration needs to be rechecked according to the new technical conditions.
Filtration efficiency . Confirm the actual particle control requirements for the target area and select the corresponding grade of filter. The HEPA and ULPA filter pages have parameters for different levels of products.
Air volume static pressure . Check the air supply volume based on area volume, ventilation needs and pollution load. Whether the old fan still has enough margin needs to be calculated based on the actual resistance curve.
Airflow organization . Confirm the relationship between supply air coverage, return air path and pressure difference. The location of the air supply vents in the old scheme may not be suitable for the new layout.
control method . If zone control or duty mode is required, the control system must be able to support it. The FFU group control system can configure operation strategies by region and time period.
Aili Industrial has manufacturing capabilities in motors, fans, control systems, sheet metal, air filters and complete machine assembly. When updating grade files and renovating old factory buildings, you can put filters, fans, structures and control conditions in the same project for verification, so that the equipment configuration and updated technical conditions match. Related products can be viewed FFU clean air supply products , please refer to the local purification at the equipment end EFU equipment side fan filter unit。
After a certain 100,000-level storage area was converted into an open assembly area, it was renovated using ISO 8 markings. After operation, it was found that the particle concentration in the assembly station was high.
The investigation found that new personnel and equipment were added to the assembly area, and the amount of dust produced was higher than that of the original storage area. The air supply volume is calculated based on the number of air changes in the old plan, which does not cover the new pollution load. When adjusting the plan, the air supply requirements under dynamic conditions were rechecked and local protection measures were added.
When another project updated the file, it only changed the 100,000 level to ISO 8, without indicating the particle size and status. The customer raised questions during the review and later added a complete statement in the technical agreement.
These two situations illustrate that the update of grade expressions must be based on verifiable technical conditions.
Check items |
Confirm key points |
|---|---|
Level description |
Note the traditional comparison premise |
Regional use |
Check usage changes |
Running status |
Clarify production conditions |
Acceptance arrangements |
Synchronously update the test protocol |