Is high efficiency filter leakage rate test: ≤0.01% necessary?
What is the acceptance criterion for HEPA filters?
Most test standards regarding the acceptance criterion for HEPA filter leak rates state that the acceptable leak limit is ultimately determined by the customer and supplier. However, for many applications using HEPA filters or different levels of cleanroom, most adopt a scan test leak criterion of ≤0.01%. Although 0.01% leak rates have been used historically and their origins are related to the accuracy of early photometer test equipment, using a 0.01% leak rate criterion as the acceptance criterion without a scientific and risk-based assessment will lead to problems associated with leak testing and may result in significant operating costs if an over-limit or failure is found in a low-risk area. Filters are not 100% retaining and particles near the MPPS are expected to penetrate the filter partially or entirely. When using lower-level HEPA filters, the factory-performed acceptable leak rate criterion for particles at or near the MPPS may be equal to or greater than the acceptance criterion for field leak rate testing, and testing acceptance criteria becomes more controversial and difficult. This is especially true in areas where leaks may occur. Therefore, when purchasing filters, it is important to consider the filter rating and how it will be tested after installation to avoid unnecessary field test failures.
ISO 14644-3 [33] provides guidance on how to implement alternative leakage criteria. In a risk-based approach, the ideal acceptance criterion is one that reflects the efficiency of the filter used or the cleanliness of the room being tested. ISO 14644-3 uses the factory filter efficiency rating as the basis for negotiating the acceptance criterion. The leakage acceptance criteria for photometric leak testing and particle counter-based leak testing should be the same because the theory and methodology behind both methods are the same. If performed properly, leak tests using a photometer and a particle counter will give the same leak rate results (Meek et al., 2011 [121]).
If the detected leakage exceeds 0.01% of the upstream concentration, it is generally considered that the leakage rate exceeds the maximum permissible standard.
However, for filter systems with an overall efficiency MPPS ≥ 99.95% and less than 99,995% (such as H13 filters), the acceptance standard is 0.1%. If a filter system with an overall efficiency of less than 99.95% MPPS is to be tested, a different acceptance standard is required, depending on the agreement between the customer and the supplier.
Importance of High Efficiency Particulate Air Filters (HEPA) and Leak Detection Methods and Standards
Cleanrooms require air filters to prevent contaminants from entering the cleanroom through their HVAC systems. Cleanrooms are controlled environments where the control of temperature/humidity, pressure, and particulate matter is critical for optimal operational performance. Cleanrooms are designed based on the cleanliness required for a specific process. In the semiconductor industry where microchip manufacturing is performed, air filtration has a higher efficiency because microchips are very sensitive to particles, especially small particles that get wedged between the conductive circuits on the wafers when the wafers are handled.
High Efficiency Particulate Air Filters (HEPA), these filters are very effective in contamination control. They filter particles as small as 0.3 microns and are widely used in pharmaceutical facilities. ULPA (Ultra High Particulate Air Filters) filter particles below 0.12 microns and are widely used in semiconductor equipment.
Importance of Filters in Cleanrooms
Managing Contamination Control in Cleanrooms through Several Activities High Efficiency Particulate Air Filters or UPLA Filters play a vital role in cleanrooms. High Efficiency Particulate Air (HEPA) filters must be as efficient as 99.97% penetrating particles, 0.3 microns. This efficiency rating is given by the U.S. Department of Energy to qualify as a true HEPA filter.
HEPA Filter Specifications
As defined by the U.S. Department of Energy (DOE) standards adopted by most U.S. industries, the minimum resistance or pressure drop a HEPA filter presents to airflow is usually specified at 300 Pascals (0.044 psi) across the filter diameter.
Specifications used by the European Union: European Standard EN 1822-1:2009 defines categories of HEPA filters by their retention at a given most penetrating particle size (MPPS).
According to GMP, filters must be leak-free. This is verified by qualification and periodic leak testing according to ISO 14644-3. Recommended Practices for HEPA Filter Construction, Performance, Labeling, and Certification are maintained by the Institute of Environmental Sciences and Underwriters Laboratories (UL). Key requirements include:
■ IEST-RP-C021 “Testing HEPA and ULPA Media, which governs requirements for filter media
■ IEST-RP-CC001 “High Efficiency Particulate Air Filters and Ultraparticulate Air Filters”, governs overall filter construction and labeling requirements
■ IEST-RP-C034 “HEPA and ULPA Filter Leak Testing, for HEPA and UL PA filter penetration (leakage) testing
■ Testing and certification to UL900 flammability requirements
■ American Standard MIL-STD-282
Other testing standards include:
■ ISO 14644-3 Test Method – Qualified Persons Used During Installed Filter Leakage Testing
■ ISO 29463 (2017) – High Efficiency Filters and Filter Media for Removal of Airborne Particles
■ ISO 16890 (2017) – Air Filters for General Ventilation
■ PIC/s PI 032-2 GMP Guide
■ EN1822 used by HEPA/UPA filter manufacturers
High efficiency filter testing is a key technology and an important step to ensure a safe working environment and improve air quality. Filter test data is more effective in formulating a more scientific maintenance and replacement plan for customers.
KLC high efficiency filter testing program:
1. Smoke test
During the testing process, we use advanced instruments and technology to accurately measure the filter's capture rate of particles of different sizes and control a variety of environmental variables.
2. MPPS test
Comprehensively analyze the filter's performance under high flow conditions to ensure it can effectively maintain good air quality and system efficiency in actual use.
3. DOP Test
Used to verify the performance of filters in capturing fine particles of dirt, especially in fields such as pharmaceuticals, electronics and aviation where air quality is extremely high. This test uses DOP aerosol to accurately simulate the filtering effect of fine particles in actual working environments.
Cleanroom grade standards
The grades of cleanrooms are usually divided according to the number and size of particles allowed in the air. Internationally, ISO 14644 is usually used for grade classification. According to this standard, the grades of cleanrooms are from high to low: ISO 1-9.
It should be noted that cleanroom standards can vary depending on the specific industry and application. In semiconductor chip production, cleanroom standards are usually more stringent to ensure that the quality and performance of the chips produced meet expectations.
Cleanroom levels can be divided into: Class 1 > Class 10 > Class 100 > Class 1000 > Class 10000 > Class 100000 > Class 300000.
Class 1 cleanrooms are mainly used in the microelectronics industry for manufacturing integrated circuits, and the precision requirements for integrated circuits are submicron.
Class 10 cleanrooms are mainly used in the semiconductor industry with a bandwidth of less than 2 microns.
Class 100 cleanliness is widely applicable and can meet the cleanliness needs of most industries. It can be used for aseptic manufacturing technology in the pharmaceutical industry. This cleanroom can be used for surgery for the manufacture of transplants and integrators, as well as isolation treatment of patients who are particularly sensitive to bacterial infections.
Class 1000 cleanrooms are mainly used for the production of fine optical products, and are also used for testing, assembly of aircraft gyroscopes, assembly of fine micro bearings, etc.
Class 10000 cleanrooms can be used for the assembly of hydraulic equipment or pneumatic equipment, and in some cases are also used in the food and beverage industry. In addition, Class 10000 cleanrooms are also widely used in the medical industry.
The permissible particle concentration of 0.5um in a Class 1000 clean room is less than 35200 (pc/m3), and the permissible particle concentration of 5um is less than 293 (pc/m3). 2. The permissible particle concentration of 0.5um in a Class 10,000 clean room is less than 352000 (pc/m3), and the permissible particle concentration of 5um is less than 2930 (pc/m3).
Safety considerations
The decoration of semiconductor cleanrooms must meet safety requirements. Generally speaking, there are a large number of flammable and explosive substances in semiconductor cleanrooms, so the relevant national safety regulations, such as fire prevention and explosion prevention, should be followed during decoration. In addition, environmental pollution and the health and safety of staff should also be considered to ensure that the decoration materials meet national standards and will not cause harm to human health.
Cleanroom air treatment system
Semiconductor cleanrooms require air treatment systems to ensure the cleanliness of the air in the workshop. The air treatment system is mainly composed of air filters, air supply systems, return air systems and exhaust systems. Among them, air filters are an important component that can effectively remove particulate matter and microorganisms in the air.
Floor, wall and ceiling decoration
In the decoration of semiconductor cleanrooms, the decoration of floors, walls and ceilings is very important because these areas are susceptible to pollution. The floor should be made of wear-resistant, anti-static and easy-to-clean materials, such as Epoxy self-leveling floor or PVC plastic floor; the walls and ceilings should be made of corrosion-resistant, anti-static and easy-to-clean materials, such as aluminum plates, stainless steel plates, glass curtain walls, etc.
Layout of electrical equipment such as lamps and sockets
In the decoration of semiconductor cleanrooms, the layout of lamps and sockets is also very important. In order to prevent pollutants such as dust and microorganisms from entering the workshop, these devices should be installed on the ceiling or above the wall height, and anti-static and non-powder-shedding materials should be selected.
Doors, windows, clean workbenches and other facilities
In the decoration of semiconductor cleanrooms, doors, windows, clean workbenches and other facilities also need special consideration. Doors and windows must be made of materials with good sealing performance and easy to clean, such as stainless steel doors and windows; clean workbenches should be made of materials that do not shed powder, slag particles, are corrosion-resistant and easy to clean, such as stainless steel workbenches.
From May 28th to 30th, the three-day SEMICON Southeast Asia 2024 was held in the Malaysia International Trade and Exhibition Center (MITEC)! KLC has been deeply involved in the clean industry for more than ten years. It appeared at SEMICON Southeast Asia 2024 to explore new trends and opportunities in the semiconductor industry with colleagues from the global industry.
2024 SEMICON Malaysia International Semiconductor Exhibition
SEMICON Southeast Asia is the largest semiconductor equipment exhibition in Southeast Asia. Attendees are offered the opportunity to discover new technology trends and markets, with a focus on key technologies and regional markets, where exhibitors can collaborate with new suppliers and discover new solutions. The purpose of this exhibition is to promote semiconductor technology through technology, innovation, and design.
At this event, KLC displayed brand-new filters, transfer windows and other equipment products. Visitors stopped at the booth to learn more about KLC clean systems. At the same time, KLC had in-depth exchanges with industry experts and companies from all over the world, and jointly discussed the needs and trends of clean rooms in the semiconductor industry, helping us to continuously improve and innovate products and services.
This exhibition was a very meaningful and valuable experience. We thank all participants and organizers for giving us the opportunity to demonstrate our expertise and technical strength. We hope to work with you in the future to jointly promote the development and progress of semiconductor clean production space and create a better production environment!
From May 21st to 23rd, the 3-day 2024 Nigeria Lagos HVAC Exhibition (MEGA CLIMA) came to a perfect end! During the period, the KLC booth attracted the attention of many exhibitors and visitors. The team members enthusiastically introduced the characteristics and advantages of filters and equipment to visitors, and won the recognition and favor of many potential customers.
Let's review the wonderful moments of 2024 MEGA CLIMA together!
During the 3-day exhibition, KLC fully displayed the clean room solutions and new refrigeration and HVAC filter products of the refrigeration and HVAC industry, and had in-depth exchanges with professionals in West Africa and surrounding areas, opening up a broader clean industry space and market.
Through this exhibition, the confidence guarantee of KLC products was brought to the Nigerian HVAC and refrigeration market, and new possibilities were brought for the application of HVAC and refrigeration products in the new era and various industries. Every separation is for a better meeting next time. Thank you for your trust and recognition of KLC, and thank you for your expectations of new friends! I hope to work with you in the future to contribute to clean production space and low-carbon life!
We will exhibit at MEGA CLIMA NIGERIA 2024 from May 21st to 24th.
We believe that your participation will add more value to the exhibition. We sincerely invite you to participate in the exhibition and discuss the development trends and future opportunities of clean rooms in the refrigeration field. If you need more information or have any questions, please feel free to contact us.
BOOTH: MEGA CLIMA #B07
Address: Landmark Centre, Lagos-NIGERIA
Time: May 21-23, 2024
Thanks!
Sincerely
On April 19, the CPHI Japan 2024 came to a successful conclusion in Tokyo. CPHI JAPAN 2024 hold at Tokyo Big Sight, from April 17th to 19th. KLC showed up with clean room solutions and discussed new development trends and future opportunities in the pharmaceutical industry with experts and audiences.
During the exhibition, KLC displayed a complete set of pharmaceutical clean room equipment and filter products, attracting the attention of many attendees. Participants had an in-depth understanding of product features and application scenarios through communication with KLC representatives.
Going global in 2024 has allowed KLC to increase its visibility and influence in the pharmaceutical industry. KLC promises to continue to be committed to the innovation and development of indoor air solutions, provide customers with better services, and make greater contributions to environmental protection. Looking forward to our next encounter!
The 2024 Russian Electronic Components and Production Equipment Exhibition (ExpoElectronica/Electrontech 2024) hold at the Crocus-Expo IEC Exhibition Center in Moscow from April 16th to 18th! KLC debuted with clean room solutions for electronics factories.
Expo Electronica, the International Electronics and Production Equipment Exhibition in Moscow, Russia, is an authoritative electronic basic product exhibition in Russia. It covers the entire electronic product industry chain from chips to finished products. It is a representative professional electronics exhibition in Russia and Eastern Europe. It is a UFI certified exhibition. Supported by the Russian government and professional electronics associations.
It is understood that the electronics industry is one of the important components of Russia's modern industry. It is expected that by 2025, the Russian electronic systems market will increase to more than 42.6 billion euros.
KLC exhibition scene grand scene
KLC Cleantech located in Guangzhou China, is a professional and experienced manufacturer for air purification equipment for 19 years, owning ISO9001, ISO14001, CE, RoHS, UL, our aim is to provide high quality products and healthy air to customers with ultimate comfort.
At ExpoElectronica 2024, KLC showed up with innovative DOP Laminar Flow Hoods, Pass Box, Weighing Room and FFU products, which not only attracted the attention of exhibitors, but also attracted consultation and exchanges from many exhibitors at home and abroad.
Over the past 19 years, KLC has remained true to its original aspirations and strived to provide sustainable air purification solutions to global industrial manufacturing companies. In the future, KLC will continue to forge ahead! See you at the next stop!
Dear Customer,
Hello! We sincerely invite you to visit the ExpoElectronica 2024 . This exhibition will bring together top companies and experts in the global electronics industry to showcase the latest technologies and products. We will also be showcasing brand new purification equipment and filters.
Participating in the exhibition will provide you with an excellent opportunity to communicate with industry leaders and learn about new market trends and developments. At the same time, you will also have the opportunity to establish new cooperative relationships and expand your business network.
Time: April 16-18, 2024
Address: International Exhibition Center Crocus Expo, 16,18,20 Mezhdunarodnaya street,Krasnogorsk 143402 Moscow Region,RUSSIAN FEDERATION
BOOTH NO: Pavilion2 HALL9 E5055
We look forward to your visit and discussing with you the future development of clean air environment in the electronics industry.
good luck!
Sincerely
Dear Customer,
We will participate in the SEMICON SOUTHEAST ASIA 2024 in May and sincerely invite you to visit. The show will provide you with a great opportunity to learn more about our latest products and solutions, as well as a great time to meet face-to-face with our team.
Exhibition Date: May 28-30.2024
Venue: Malaysia International Trade and Exhibition Center(MITEC)
We look forward to your visit and sharing our latest achievements and technological innovations with you. If you have any questions or require further information, please feel free to contact us.
Thanks!
Best Regards
Dear Customer,
We sincerely invite you to visit CPHI Japan 2024. This will be an excellent opportunity to showcase new pharmaceutical technologies and products. We look forward to your visit to discuss the development and future trends of the industry.
Exhibition Time: April 17-19, 2024
Exhibition Hall Address: EAST HALLS 4,5&6 TOKYO BIG SIGHT TOKYO JAPAN
Our booth number: HALL 4 | 4X-32
Looking forward to meeting you!
Disinfection and sterilization are two different concepts. The disinfection and sterilization methods commonly used in biological clean room are compared, and three common methods such as ultraviolet sterilization, formaldehyde disinfection and ozone disinfection are described.
Part 1 Foreword
According to data, the human body about every 6~7cm2 of skin can carry 1~10000 bacteria, of which about 1% is pathogenic, human breathing, speech will also emit bacteria. Obviously, for clean workshops, especially biological clean rooms with relatively high cleanliness requirements, it is crucial to prevent the generation, removal and elimination of bacteria. Disinfection and sterilization are two effective methods to remove and destroy bacteria and ensure the microbial requirements of biological clean rooms.
Part 2 Disinfection and sterilization are two different concepts
Disinfection and sterilization are two different concepts. Sterilization, which is to kill or remove all microorganisms (including bacteria, viruses, etc.) in a substance, has absolute significance. That is to say, corresponding to sterilization is not sterilization, there is no intermediate state of more and less sterilization. In this respect, absolute sterilization is almost non-existent because it is difficult to achieve or for an infinite period of time.
Disinfection is a treatment that kills most pathogenic microorganisms or reduces them to a certain extent. In this process, some bacteria or viruses are not destroyed due to resistance to heat or drug force, which has a relative significance. In other words, the disinfectant itself has a certain range of sterilization.
It is not difficult to see that the understanding of the relative and absolute meaning of disinfection and sterilization here is different from our usual understanding. What we usually call "sterilization" should be accurately called "sterilization".
Part 3 Comparison of common disinfection and sterilization methods
Disinfection and sterilization, from the mechanism point of view, there are no more than four: dry heat method, wet heat method, drug method, electromagnetic radiation method. From these four basic methods, a variety of disinfection and sterilization methods with different application scopes and application effects are derived.
3.1 Common sterilization methods
Commonly used sterilization methods are: high temperature dry sterilization, high pressure steam sterilization, gas sterilization, filtration sterilization, radiation sterilization and so on.
3.2 Common disinfection methods
Commonly used disinfection methods are: boiling and atmospheric steam disinfection, low temperature disinfection, ultraviolet irradiation disinfection, pharmaceutical disinfection and so on.
Part 4 Ultraviolet sterilization
Ultraviolet radiation is a kind of electromagnetic radiation method, which has many applications in local clean workshops, but its effect is limited, because the effect of ultraviolet light is limited, it can not be used to replace chemical disinfection, and ultimately sterilization, and ultraviolet radiation can not be used."
1、Factors influencing the effect of ultraviolet disinfection and sterilization
The factors that affect the effect of ultraviolet disinfection and sterilization are:
(1)Lamp use time: the bactericidal power of the ultraviolet lamp decreases with the increase of the use time, in general, the output power of the ultraviolet lamp after 100h is the rated output power, and the lighting time of the ultraviolet lamp to 70% of the rated power is the average life. The average life of domestic UV lamps is generally about 2000h.
(2)Environmental conditions: Generally, under the conditions of ambient temperature of 20℃ and relative humidity of 40~60%, the sterilization effect of UV lamp is the best. When the temperature is 0℃, the sterilization effect is less than 60%.
(3)Irradiation distance: within 500mm from the center of the lamp, the irradiation intensity is inversely proportional to the distance, and above 500mm, the irradiation intensity is approximately inversely proportional to the square of the distance.
(4)Strain: Because of the membrane structure and shape of the bacteria, the bactericidal effect of ultraviolet light on the strain, that is, the bactericidal rate is also different. If the product of irradiation intensity and irradiation time is assumed to be the irradiation dose, when the required dose of E. coli is 1, staphylococcus, tuberculosis bacillus and the like need about 1~3, subtilis and its spores and yeast and the like need about 4~8, mold about 2 ~ 50.
(5)Installation method: The penetration rate of ultraviolet light is low, which is greatly affected by shielding and installation method. In the biological clean room, there are generally several installation methods of chandeliers, side lights and overhead lights, of which the sterilization effect of overhead lights is the best.
Due to the limitations of ultraviolet sterilization effect and the damage to the human body that may be caused by sterilization, the use of ultraviolet lamps for comprehensive sterilization of biological clean rooms has been rarely used, only individual rooms or local sections such as dressing rooms, laundry rooms, etc. At present, ultraviolet sterilization is commonly used in combination with HVAC system gas phase cycle disinfection.
2、Gaseous phase cycle disinfection
Gaseous phase cycle disinfection, is to take some measures, let the air organized circulation through the ultraviolet lamp effective irradiation area, increase the irradiation time and irradiation intensity at the same time, the ultraviolet radiation does not leak hurt, and does not produce ozone, so the ultraviolet lamp can not be turned off to achieve the purpose of circulating air disinfection, disinfection effect is also greatly improved.
Part 5 Formaldehyde disinfection
Formaldehyde disinfection is a kind of pharmaceutical disinfection, and is also a common way of biological clean room disinfection. There are two kinds of formaldehyde disinfection: first, on-site disinfection, only a small range of disinfection in the local space of the clean room, formaldehyde can be used directly in the room evaporation (or heating evaporation), the effect is poor, and the detoxification after disinfection is inconvenient. The other is combined with the HVAC system, formaldehyde from the disinfection tank with jacket overflow into the air supply point main pipe of the air conditioning unit and then into the clean room, in order to increase the evaporation intensity of formaldehyde, the disinfection tank jacket through the steam.
It should be noted that because formaldehyde contains trace amounts of formic acid, it has a certain corrosive effect on galvanized air pipes, and it is recommended to use stainless steel pipes.
Part 6 Ozone disinfection
Ozone disinfection is a newly developed disinfection method. It is characterized by easy to use, safe, flexible installation and obvious bactericidal disinfection.
Ozone disinfection requires the installation of an ozone generator. The ozone generator can be installed in a variety of ways: desktop, mobile or split type, placed directly in the clean room that needs disinfection; Pipe type, can be installed in the HVAC system's supply and return air main pipe (where the air pipe needs to be expanded); In addition, the ozone generator can also be fixed on the back end of the efficiency filter in the purification air conditioning unit. The latter two installation methods not only disinfect the clean room internally, but also disinfect the air ducts, filters, and internal equipment of the HVAC system.
At present, ozone generators used in clean room disinfection have been produced by a number of domestic manufacturers. The amount of ozone that needs to be consumed when ozone disinfection is used in a biological clean room (or the output of the ozone generator that needs to be selected is the discharge water) can be referred to the relevant manufacturer's information. Compared with formaldehyde disinfection, the advantage of ozone disinfection is that it is easy to install and non-corrosive to air ducts and filtration materials when combined with HVAC systems.
Part 7 Conclusion
(1)Disinfection and sterilization are two different concepts.
(2)The choice of disinfection and sterilization method should be determined according to the decoration, equipment and material of the biological clean room, production characteristics, etc., and consider the corrosiveness and economy of the disinfectant, the convenience, safety and the feasibility of GMP verification.
(3)Formaldehyde and ozone are two commonly used disinfection methods. The GMP Certification Guide recommends the use of ozone disinfection.
(4)Either way, it should be used in conjunction with the HVAC system in the clean room. For the residue that is harmful to people after disinfection, it should be diluted to a safe concentration through the ventilation device in time.
(5)Any disinfection methods, disinfectants have a certain degree of resistance, and should be replaced after a period of use.
Dear customer,
On this special occasion, I would like to express my sincerest blessings to you. As New Year’s Day approaches, I wish you and your family happiness, health, and success in the new year.
Thank you for your trust and support in us over the past year. Your trust is the driving force for us to keep moving forward, and your support is the source of our continuous growth. We will continue to work hard to provide better services in return for your love.
Wish you a Healthy,Wealthy and Lucky 2024!