ISO-6 cleanroom classification is one of the highest levels of the cleanroom classes. The ISO cleanroom standards are set by the International Organization for Standardization (https://www.iso.org/standards.html). They are a private international organization with a membership of 167 national standards bodies. The ISO cleanroom classification system used in United States primarily for pharmaceutical cleanrooms, medical device cleanrooms, biotech cleanrooms, and life-science cleanrooms. The Europe and the rest of world uses the ISO cleanroom classification system for all industries except semiconductor.
If you are looking for more details, kindly visit EZONG.
Figure 1. ISO-6 optics cleanroomISO-6 cleanrooms are required to have 180 air changes per hour of HEPA filtered air and less than 293 particles/meter3 greater or equal to 5 microns.
By comparison, a conditioned office space (non -cleanroom space) would have more than 100X as many particles per meter3. ISO-6 cleanroom classification also has requirements for >0.5 micron and >1 micron size particles (see table 1).
Table 1. ISO Cleanroom ClassificationsThere is a separate FED 209E cleanroom classification system that has been historically used in United States for industrial cleanrooms such as semiconductor cleanrooms and printed circuit board cleanrooms. The ISO cleanroom classification is on metric system (particles per meter3). The FED 209E cleanroom classification system is based on imperial system (particles per feet3). There are comparable ISO and FED 209E cleanroom classes for each level of cleanliness. An ISO-6 cleanroom classification corresponds to FED 209E class cleanroom classification (see table 2).
Table 2: FED STD 209E Cleanroom ClassificationsCommon applications for ISO-6 cleanroom classification rooms
ISO-6 air flow is typically recirculating. In recirculating cleanrooms, the air is exhausted thru low return air grills back to the plenum where the HEPA or ULPA fan filter units reclean the air and draw it back into the cleanroom. As a result, the air in the cleanroom is cleaned over and over again (180x per hour), resulting in the cleanest environment possible.
Filtration for ISO-6 classification cleanrooms is done with HEPA or ULPA filters. The best modular cleanroom design uses a negative pressure plenum with HEPA or ULPA fan filter units in the ceiling and incorporated low wall air returns to achieve laminar air flow. The HEPA or ULPA filtered air sweeps dirt down to the floor and horizontally to the low wall air returns. ULPA filters are commonly used in ISO-6 cleanrooms because ULPA filters screen particles down to 0.12 micron size whereas HEPA filters only screen particles down to 0.3 micron size.
Cleanroom gowning for ISO-6 classification cleanrooms. Typically, cleanroom personnel wear cleanroom knee high shoe covers to avoid tracking dirt into the cleanroom and full cleanroom bunny suits. All the garments are manufactured from special non particulating cleanroom approved materials. Options include disposable or washable (you send back to cleanroom laundry) garments. It is critical the personnel wear cleanroom garments if user wants to maintain ISO-6cleanroom classification.
Figure 5. Cleanroom garments for ISO-6 cleanroomsWhy gown room/airlock for ISO-6 classification cleanroom. Because an ISO-6 classification cleanroom only allows 7 particles/ft3 > 5 microns if a door is even briefly opened to the dirty exterior it will let thousands of particles. The gown room/airlock prevent the particles from entering the ISO-6 cleanroom. The gown room will have HEPA filtration to reduce the number of particles the ISO-6 room will be exposed to. Gown room / airlocks are a critical part of your ISO-6 classification cleanroom.
Particle testing for ISO-6 cleanrooms. Particle testing must be done with bench top laser particle counters which measure a minimum of 1 ft3 per sample location. The larger sample size is due to the extremely small number of particles per cubic foot that are found in ISO-6 cleanrooms.
Figure 6. Climet 150T particle counterIf you want to learn more, please visit our website clean room iso 6.
Property American Cleanroom Systems
The author Anthony Chien has worked at American Cleanroom Systems for past 10 years. He has more than 40 years of cleanroom experience. Anthony has a BS and MS in Electrical Engineering specializing in semiconductor manufacturing from the University of Illinois. American Cleanroom Systems is a design build modular cleanroom manufacturer based in Rancho Santa Margarita CA. It is expert in ISO-5 thru ISO-8 (class 100 to class 100k) modular cleanrooms for pharmaceutical cleanrooms, medical device cleanrooms, and industrial cleanrooms.
Clean rooms are classified according to the cleanliness level of the air inside the controlled environment. The clean room class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air. The primary authority in the US and Canada is the ISO classification system ISO -1.
This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the &#;cleanest&#; class and ISO 9 is the &#;dirtiest&#; class. Even if it&#;s classified as the &#;dirtiest&#; class, the ISO 9 clean room environment is cleaner than a regular room.
The most common ISO clean room classes are ISO 7 and ISO 8. The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Class 10,000 and Class 100 000.
The old Federal Standard 209E ( FS 209E ) includes these clean room classes : Class 100,000; Class 10,000; Class 1,000; Class 100; Class 10; Class 1. This standard was replaced in by ISO--1. It was withdrawn in , but it is still widely used.
Clean rooms must also follow industry-specific and international standards. For example, EU GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies.
You might also like this article &#;>How Classification Impacts your Cleanroom Design
Want to learn more about Clean Rooms? &#;>What is a Clean room?
Request a quote
Download our PDF Cleanroom Brochure
Are you interested in learning more about half swing door? Contact us today to secure an expert consultation!