The acceptance criteria for Gel Seal HEPA Filters is a systematic process that follows a comprehensive standard system from international to national levels and from product to system. Below is a detailed explanation of the core international and national acceptance criteria.
The performance of Gel Seal HEPA Filters, system installation, and on-site leak testing form a complete acceptance system. The core standards and processes can be summarized in the following framework:
I. International and National Standards for Gel Seal HEPA Filters
1. International Standard EN 1822 (European Standard, widely adopted globally)
- This is one of the most authoritative international standards for Gel Seal HEPA Filters.
- EN 1822-1: Classification, performance testing, and marking.
- EN 1822-2: Aerosol production, measuring equipment, and particle counting statistics.
- EN 1822-4: Leak testing (scan method).
- EN 1822-5: Efficiency testing (most penetrating particle size method).
- Core Grades:
- H13: Filtration efficiency for MPPS (most penetrating particle size) ≥99.95%.
- H14: Filtration efficiency for MPPS ≥99.995%.
- U15-U17: Ultra-low penetration air filters (ULPA) grades.
- Acceptance Significance: When purchasing Gel Seal HEPA Filters, it is mandatory to require suppliers to provide a third-party MPPS efficiency test report based on EN 1822-5, clearly indicating compliance with H13 or H14 grade. This is the baseline for product qualification.
2. Chinese National Standard GB/T 6165-2021 "Performance Test Methods for High-Efficiency Air Filters: Efficiency and Resistance"**
- This standard equivalently adopts ISO 29463 (which is technically coordinated with EN 1822) and is the latest authoritative standard in China.
- It also uses the MPPS method for testing.
- Efficiency Grades:
- High-Efficiency Air Filters (HEPA): H13, H14.
- Ultra-Low Penetration Air Filters (ULPA): U15, U16, U17.
- Acceptance Significance: In domestic projects, reports based on GB/T 6165 have the same validity as those based on EN 1822. It is the core basis for domestic acceptance of the filter's own performance.
3. American Standard IEST-RP-CC007.3
- This is a recommended practice by the Institute of Environmental Sciences and Technology (IEST) and is widely used in North America.
- The testing method is similar to the traditional DOP method.
- Common Grades:
- HEPA Filter: Efficiency for 0.3μm DOP particles ≥99.97%.
II. European, Chinese, and American Installation and On-Site Testing Standards for Gel Seal HEPA Filters (System Sealing)
These standards specify how to test the integrity of the entire system (including the filter itself, gel seal, and installation frame) after the filter is installed on-site. The core is on-site leak testing.
1. International Standard ISO 14644-3:2019 "Cleanrooms and Associated Controlled Environments - Part 3: Test Methods"
- This is the globally recognized standard for cleanroom performance testing.
- Appendix B.6: Leak Testing After Filter Installation
- Testing Method: Use an aerosol photometer and artificial aerosol (such as PAO, DOP) for upstream smoke injection and downstream scanning.
- Acceptable Leakage Standard:
- For HEPA/ULPA Filters: The leakage rate at any point must not exceed 0.01% of the upstream concentration.
- For ISO Class 5 (Class 100) or higher cleanrooms, even if the leakage rate at a single point is less than 0.01%, if there is a trend of localized concentrated leakage, it should be repaired.
- Acceptance Significance: This is the golden rule for international project acceptance. The test report must clearly show that the leakage rate at all scanned points is below 0.01%.
2. Chinese National Standard GB/T 25915.3-2010 "Cleanrooms and Associated Controlled Environments - Part 3: Test Methods"
- This standard is equivalent to ISO 14644-3:2005 (note the version difference).
- The specified testing methods and acceptable leakage standard (≤0.01%) are completely consistent with ISO 14644-3.
- Acceptance Significance: This is the mandatory basis for domestic cleanroom project acceptance. The final acceptance report must be based on this standard.
3. Industry Construction and Acceptance Standard GB 50591-2010 "Cleanroom Construction and Acceptance Code"
- This is a detailed specification for cleanroom construction in China.
- Article 5.4.5: It clearly stipulates that "after installation, high-efficiency air filters should be tested for leaks… using particle counters or photometers for scanning detection… The leakage rate should comply with the provisions of Article 5.4.3 of this specification (i.e., it should not exceed 1.5 times the factory-qualified rate, usually interpreted as ≤0.01%)".
- Acceptance Significance: This standard is the legal and contractual basis for acceptance, emphasizing that leak testing is a necessary procedure after installation.
III. Cleanroom Overall Performance Standards for Gel Seal HEPA Filters (Final Environment)
After the filter installation leak test is qualified, it is also necessary to ensure that the entire cleanroom environment meets the design grade.
1. ISO 14644-1:2015/ GB/T 25915.1-2021: Specifies the air cleanliness grade of cleanrooms (such as ISO Class 5, Class 7), based on the allowable particle concentration per unit volume.
2. Acceptance Significance: Filter leak testing is a prerequisite for achieving the air cleanliness grade. The final acceptance must meet both the core indicators of particle concentration grade and filter installation leakage rate.
IV. A Complete Acceptance Process for Gel Seal HEPA Filters
1. Goods Arrival Acceptance: Verify the filter model, size, and efficiency grade (H13/H14), and check the third-party product test report based on EN 1822 or GB/T 6165.
2. Post-Installation Acceptance: A third-party testing agency should conduct PAO scan leak testing on each filter and its sealing joints according to ISO 14644-3 or GB/T 25915.3 standards. The leakage rate at all points must be ≤0.01%, which is the most critical acceptance link.
3. Comprehensive Acceptance: On the basis of qualified filter leak testing, conduct performance tests for the entire cleanroom (such as particle counting, pressure difference, air velocity, etc.) to ensure compliance with the cleanliness grade specified by ISO 14644-1 or the design.
The international and national acceptance criteria for Gel Seal HEPA Filters is a multi-level system. At the product level, look at the MPPS efficiency report based on EN 1822 or GB/T 6165; at the installation sealing level, strictly follow the on-site leak testing standard (≤0.01%) based on ISO 14644-3 or GB/T 25915.3; at the final environment level, meet the cleanliness grade of ISO 14644-1. Failure in any link means the acceptance is unqualified.
