ISO 6 Cleanrooms
An ISO 6 clean room (Class 1000 cleanroom) is a soft- or hard-sided wall manufactured structure that utilizes HEPA filtration systems to maintain air cleanliness levels of a maximum of 1,000 particles (≥0.5 µm) per cubic meter of inside air. Class 1000 cleanroom filtration system must provide filter coverage of 20-30% and – a minimum of 180 air changes per hour. The standard air flow rate for an ISO 6 filtration system is 18-32 CFM per square foot.
Cleanrooms By United produces extremely practical ISO 6 cleanrooms that meet all required specifications and requirements. We provide the layout, square footage, and features that your project specifications require. The custom, flexible, modular construction of our ISO 6 clean rooms makes them easy to expand, reconfigure, or relocate as your cleanroom needs evolve.
Contact us for more information regarding our class 1000 cleanroom options or call us at 800-959-0878 and we will gladly answer any questions that you may have. Cleanrooms By United is your trusted source for technologically advanced, high-efficiency ISO 6 clean rooms.
ISO 6 Cleanroom Standards
Classification for cleanrooms ranges from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest.” These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. An ISO class 6 cleanroom was previously defined under US Federal Standard 209E but is now defined under ISO 14644-1, however, both are still regularly used as reference points.
- US Federal Standard 209E: denotes the number of particles (≥0.5 µm or larger) per cubic foot (f³) of air.
- ISO 14644-1: replaced federal standard 209E in 2001 but is still used as a reference. It denotes the number of particles (≥0.1µm to ≥5µm or more) per cubic meter (m³) of air.
ISO 14644-1 Standard for Maximum Number of Particles Permitted/m³ for ISO 6 Cleanrooms
(FED STD 209E Equivalent: Class 1,000)
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5µm||≥1µm||≥5 µm|
US FED Standard 209E Maximum Number of Particles Permitted/ft³ for Class 1,000 Cleanrooms
(ISO 14644-1 Equivalent ISO 6)
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5µm||≥5 µm|
What Type of Cleanroom is Right for Your Project?
A typical cleanroom is designed to keep outside contaminants and particles at a minimum based on the ISO clean room standards. Once fully built and operational, an isolated cleanroom is free from outside particles and contamination. However, the two things that can introduce particles and contamination into your cleanroom are people and processes.
Classification for cleanrooms ranges from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest.” These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. The lower the ISO class the more stringent the requirements for keeping particles and contamination to the acceptable levels of the room class.
As an example, Class 10,000 cleanroom filtration systems must provide filter coverage of 15-25% and – a minimum of 60 air changes per hour. The standard air flow rate for an ISO 7 filtration system is 9-16 CFM per square foot. The chart below provides an explanation of the differences between our clean room classes.
Hard-walled Modular Cleanroom Advantages
Due to their ease of maintenance and simple installation methods, hard-walled modular cleanrooms are increasing in popularity in numerous industries across the globe. Since they can be installed quickly and easily and can be modified or even relocated with minimal expense and downtime. Many prefabricated modular cleanrooms are almost 100% reusable. Some additional benefits of a hard-walled modular cleanroom include:
- Less expensive than sheetrock construction
- Easily installed in days, not weeks
- Factory-cut options, with numerous custom options
- Pre-wired UL Classified raceway installation capabilities
- Insulated wall options for reduced energy costs
- Anteroom and gowning room options for reduced contamination
- Airlock, air shower, and pass-through box options for reduced contamination from personnel and materials
Flexible & Affordable Modular Cleanroom Systems
Since they are constructed of hard or soft panels with a hard ceiling, modular cleanroom systems are highly configurable. Soft panel cleanrooms have walls made from clear PVC and one small opening for entering and exiting the area. Hard panel systems consist of prefabricated panels that join to create a square or rectangular room. Hard-walled cleanrooms are fully enclosed and can be fitted with doors, windows, and transfer hatches, just like a permanent cleanroom.
Some of the advantages modular cleanroom systems provide over permanent clean rooms include:
- Versatility: A modular cleanrooms can be readily assembled, disassembled, and relocated, often in just a few days or less
- Easily reconfigurable: The layout of a modular cleanroom can be rearranged, expanded, retrofit, and/or upgraded.
- Cost-effective: Modular cleanrooms are designed and manufactured offsite for a fraction of the cost of permanent construction.
- Time Saving: Modular cleanroom systems can be installed onsite in a fraction of the time as permanent construction.
- Reduced downtime: Modular cleanroom installation causes far less disruption to daily operations, allowing many users to keep some or all operations running without disruption.
- Leasing: If you lease your space, the modular option allows you to uninstall the clean room you need and take it with you if your operation changes locations.
- R.O.I.: Because it can be taken down, moved, and re-erected, a modular cleanroom is considered a piece of capital equipment and can be treated as such for taxation purposes.
- Cleanliness: A modular cleanroom is the better option for cleanroom requirements above ISO 6 classification. The materials used in these systems do not shed like drywall or metal studs, reducing the level of contamination.
ISO Class 6 Cleanroom Gowning Protection Specifications
Cleanroom requirements vary widely based on industry standards and the type of processes being performed. Always consult with a cleanroom professional for assistance in selecting the design and classification that are best suited for your application. Class 1000 gowning requirements include:
- Bunny-suit coveralls
- Beard covers – gloves
- Shoe covers
ISO Class 6 Protective Requirements
To maintain the ISO 6 cleanliness classification, cleanrooms implement gowning protocols to prevent contamination from people and clothing. Required gowning attire for Class 1000 cleanrooms typically includes coveralls, hoods and shoe covers/booties made from non-woven materials. Gloves are also worn to protect sterilized surfaces from contamination.
In addition to gowning requirements, air showers and pass-through chambers are typically incorporated into the design of an ISO 6 cleanroom to prevent contaminants from entering the environment. Specific gowning protocols for Class 1000 cleanrooms can vary based on the industry and application. It is critical that you work with a cleanroom consultant to determine what preventative measures are necessary for your specific application. Common ISO 6 cleanroom contamination protection measures include:
- Product pass thru chambers
- HEPA fan filters
- Heat welded vinyl or epoxy floors
- Gowning/Ante Rooms and Air Showers
- Air locks
- Air Handling System and Humidity Control
- Tacky mats
- Sealed lighting
- Bunny suit, booties, and hood requirements
- Stainless steel bench and hands free sink
ISO 6 Cleanroom Applications
An ISO 6 cleanroom provides air cleanliness levels of a maximum of 1,000 particles (≥0.5µm) per cubic foot with a minimum of 180 air changes per hour. Industries that utilize ISO 6 cleanrooms include:
- Medical device manufacturing
- Electronics manufacturing
- Pharmaceutical compounding
- Aerospace product development
Discover the Cleanrooms By United for Class 1000 Cleanrooms Solutions
Contact Cleanrooms By United for more information regarding our ISO 6 clean room options or call us at 800-959-0878 and we will gladly discuss your specific cleanroom requirements. Cleanrooms By United is your trusted source for premium grade, high-efficiency Class 1000 cleanrooms. Find out how we manufactured an ISO 6 cleanroom for a Biopharmaceutical facility.