What is a Cleanroom?
What is a Cleanroom?
Modular portable clean room systems provide advanced cleanroom solutions for your manufacturing constraints. Depending on your specifications, a modular cleanroom can be designed to handle your project’s exact particulate level requirements. Whether you require an ISO level 5, 6, 7, 8, or 9 prefab cleanroom for your particular application needs, Cleanrooms By United has you covered.
At Cleanrooms By United, we offer complete design to best accommodate available square footage and features that your project requires. The custom, flexible, modular construction of our portable clean rooms makes them easy to expand, reconfigure, or relocate as your cleanroom needs progress.
Contact us for more information regarding your modular cleanroom design requirements 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 14644-1 compliant clean rooms (Class 9 to class 5).
What Cleanroom Classification do I Need?
An important factor in selecting the prefab clean room you need is the class, or classification, required. Key considerations when determining the correct class of cleanroom for your application include:
- What are the sources of contamination in my location?
- How small are smallest particles I need to remove from the air?
- How much air do I need to circulate to remove contaminants
Cleanroom Classes Defined
What are Clean Rooms used for?
Customized hard wall cleanrooms can be manufactured to fit any dimensions and with unique special features that deliver the performance you need. Since they are completely customizable, modular clean rooms provide a higher level of design flexibility than standard drywall constructed cleanrooms. Some of the industries that regularly utilize prefab cleanrooms include:
- Medical Device
- Cosmetic packaging
- USP compounding
- Printing Rooms
- GMP rooms
- Beverage / Bottling Rooms
ISO 14644-1 Modular Clean Room Classifications
Cleanrooms By United provides ISO Class 5 (Class 100) through ISO Class 9 (ambient) cleanrooms. Particle count is measured at work surface height.
|FED STD 209E equivalent|
|ISO 5||100,000||23,7000||102,000||3,520||8,320||293||Class 100|
|ISO 7||352,000||83,200||2,930||Class 10,000|
|ISO 8||3,520,000||832,000||29,300||Class 100,000|
|ISO 9||35,200,000||8,320,000||293,000||Room Air|
Common Modular Clean Room Options/Variations
Air Flow Principles and Cleanroom Standards
Cleaning the air itself is usually not the most difficult part of maintaining a cleanroom environment. Keeping the air clean is the biggest challenge. And to keep the air clean, you need to keep it fresh.
The air change rate (or ACR) of a cleanroom is a key factor in determining its classification. “Air change rate” refers to how quickly the air inside a cleanroom is pumped through and replaced with newly filtered air coming in from outside the cleanroom. How long does it take for fresh air that is pumped into a cleanroom to be exhausted out and replaced?
For ISO Class 9 through Class 6 cleanrooms, ACR is calculated by changes-per-hour; for Class 5 through Class 1 cleanrooms, ACR requirements are measured in meters per second of airflow. For example, an ISO Class 8 cleanroom requires a minimum of 10 air changes per hour—the air inside the cleanroom will be entirely “new” every six minutes or less. In a Class 5 cleanroom, air must travel through the room (from the filter input to the exhaust ports) at no less than 40 feet per minute.
What are the ISO Cleanroom Standards?
|Air changes per HR/Min||300 to 480 / 5 to 8||180 / 3||60 /1||20 /0.33|
|Filter coverage %||60 – 70||20 – 30||7 – 15||4 – 5|
|CFM per square foot||36 – 65||18 – 32||9 – 16||4 – 8|
|Filter Efficiency||99.997% HEPAs||99.997% HEPAs||99.997% HEPAs||99.97% HEPAs|
|Ceiling Type||Aluminum T-bar grid||Aluminum T-bar grid||Conventional T-bar grid||Conventional T-bar grid|
|Light Fixture type||Tear drop or 2’x4’ cleanroom fixture||2’x4’ cleanroom fixture||2’x4’ cleanroom fixture||2’x4’ standard fixture|
|Ceiling Panel||FRP, Vinyl rock or Mylar||Vinyl rock or Mylar||Vinyl rock or Mylar||Vinyl rock or Mylar|
|Flooring cover||Welded sheet vinyl or Epoxy||Welded Sheet vinyl or Epoxy||Sheet vinyl or VCT||Sheet vinyl or VCT|
|Flooring base||Cove or Aluminum base channel||Cove or Aluminum base channel||Cove or Aluminum base channel||Cove or Aluminum base channel|
|Air Returns||Low wall on long axis||Low wall at perimeter||Low wall||Low wall or ceiling|
Why are HEPA Filters Used in Cleanrooms?
Because the contained space of a modular clean room is intended to reduce particulate contamination, HEPA air filters are key to their performance. All the air delivered into a modular clean room passes through one or more High Efficiency Particulate Air filters, which trap any particles larger than 0.3 microns in size. For applications that require even greater cleanliness, ULPA (Ultra Low Particulate Air) filters that trap particles as small as 0.12 microns can be used.
Filtered air is supplied from overhead and, in most cases, passes out of the cleanroom via low wall vents. Single pass modular cleanrooms simply pull air in through the ceiling and exhaust it out; recirculating modular cleanrooms recycle the exhaust air back into the filter in a process of continuous circulation. Each design provides different benefits, and can impact other environmental parameters, such as temperature, humidity, and pressure.
What is the Major Source of Contamination in Portable Clean Rooms?
The most common contaminants that can cause problems in cleanroom environments are generated from five basic sources: the facility, people, tools, fluids, and the product(s) being manufactured can all contribute to contamination.
Key Elements of Cleanroom Contamination Control
- Cleanroom Design: Prefabricated cleanrooms are designed to achieve and maintain an airflow in which essentially the entire body of air within a confined area moves with uniform velocity along parallel flow lines. This air flow is called laminar flow. The more restriction of air flow, the more turbulence; turbulence can cause particle movement.
- High Efficiency Particulate Air (HEPA) Filters: These filters are the key component in maintaining contamination control in a modular clean room. HEPA filters remove particles as small as 0.3 microns, with a 99.97% minimum particle-collective efficiency.
- Filtration: In addition to HEPA filters, modular cleanrooms may use a number of other filtration mechanisms to remove particles from gases and liquids. These filters are essential for providing effective contamination control.
- Cleaning: Cleaning is an essential element of contamination control. Decisions need to made about the details of cleanroom maintenance and cleaning. Applications and procedures need to be written and agreed upon by cleanroom management and contractors (if used).
- Electrostatic Discharge (ESD): When two surfaces rub together, an electrical charge can be created. Moving air creates a charge. People touching surfaces or walking across the floor can create a static charge. Special care is taken to use ESD protective materials in modular cleanrooms to prevent damage to products caused by ESD.
Cleanroom Gowning Requirements
The requirements for cleanroom garments vary based on the classification level and industry you work in. Lower classified cleanrooms (ISO 7 and 8) typically require smocks, shoe covers, gloves, and hairnets, while more stringent cleanrooms (ISO 6 and up) require full coveralls made of Goretex or similar nonwoven (and therefore non-shedding) materials, along with hoods, gloves, and shoe covers.
What are the Basic Cleanroom Gowning Procedures?
People and clothing are two of the main sources of particulate contamination in a cleanroom environment. Therefore, a well maintained gowning rooms and proper gowning procedures are critical to maintaining cleanroom cleanliness.Important information for personnel to remember when gowning prior to entering the cleanroom include:
- Always clean your street shoes before entering the gowning room. Automatic shoe cleaners and adhesive floor mats are an effective way to remove dirt and contaminants from shoes. Be sure to put on shoe covers before entering the gowning area.
- Never let clean surfaces contact dirty ones. Always wash your hands before handling cleanroom garments, and never let clean garments touch a dirty floor or other surfaces.
- When gowning, start with your gloves, then work from the top down. As needed, put on your hairnet, hood, mask, and coveralls, with the hood tucked inside. Finally, put on boot covers. Boot covers and gloves should overlap coveralls.
What is the Difference between a Cleanroom and a Controlled Environment?
Although the two are very similar, a cleanroom and a controlled environment are not the same. In a controlled environment, certain parameters must be carefully controlled, such as temperature, pressure, humidity, and physical separation from non-controlled environments. However, unlike a cleanroom, a controlled environment generally doesn’t have to meet any specific particle contamination standards.
Therefore, it could be said that a cleanroom is a controlled environment that must meet far stricter criteria. A cleanroom also requires a specific temperature, pressure, and humidity, along with separation from outside environments and careful management of airborne particulates. All these factors must be closely monitored and controlled to maintain specific standards and conditions.
Contact Cleanrooms By United for Modular Cleanroom Solutions Today
Cleanrooms By United is your trusted manufacturer and supplier of advanced quality prefab cleanrooms.