Cleanroom vs. Controlled Environment

Cleanroom vs. Controlled Environment

Deciding between a clean room vs. a controlled environment requires a thorough understanding of your application and facility requirements. Some operations even use both, reserving a cleanroom for certain quality controls and more sensitive tasks. Read on to learn what controlled and cleanroom environments are, and what types of applications each is best suited for.

What is a Controlled Environment?

Controlled environments are spaces that control several local factors by adjusting resource inputs and outputs. Generally, the functions regulated by a controlled environment include the following:

• Temperature
• Humidity
• Light spectrum and intensity
• Airflow
• Carbon dioxide and oxygen levels

Controlled environments don’t need to meet particle filtration thresholds like cleanrooms do. Instead, their certification requirements are based on factors such as temperature and humidity controls. These must be periodically measured and logged, so the environmental controls can be adjusted accordingly.

If your requirements primarily revolve around temperature and/or humidity control, without the need for strict cleanliness or filtration, a controlled environment will meet your needs.

Common Applications for Controlled Environments

Controlled environments are used in numerous industries:

• Life science laboratories
• Engineering labs
• Laser labs
• High-energy physics facilities
• Quality labs
• Grow Rooms (e.g. greenhouses, indoor farming, cannabis)
• Clean manufacturing rooms
• Pharmacies
• Quarantine sections of hospitals

For the latter, the most important controls include humidity, airflow, temperature, and lighting. Controlling humidity and air exchanges can dramatically reduce the transmission of pathogens.

What is a Cleanroom?

Cleanrooms are a specialized type of controlled environment. They require more stringent controls on temperature and pressure, and their local air supply must be kept separate from the outside environment. Cleanrooms filter contaminants at the microscopic level, maintaining air purity with a High-Efficiency Particulate Air (HEPA) filtration system.

Cleanrooms are required to meet ISO 14644-1 or FED Std 209E standards, which takes into account both the cleanliness and the number of air changes per hour. This is necessary to maintain precise filtration and particulate controls.

To certify that one of these classifications is being met, a room needs to be particle tested and have continual measurements of air pressure and filtration.

Some industries and applications will have additional cleanroom requirements, such as ASTM E2352 for Aerospace cleanrooms. Semiconductor companies require cleanrooms rated at Class 5 or lower, along with their own “SEMI” industry standards. Pharmaceutical and medical industries have other specific cleanroom standards.

Common Applications for Cleanrooms

What a cleanroom is used for depends on how sanitary a lab or other setting must be for a given application. Highly valuable equipment depends on accurate cleanroom controls, which are set by a classification system outlined in ISO-5/class 100 and ISO-6/class 1000.

There are also industry-specific cleanroom standards. The most common cleanroom types are as follows:

• Semiconductor manufacturing cleanrooms
• Pharmaceutical manufacturing cleanrooms
• Research and development cleanrooms
• Laser and optics cleanrooms

Cleanroom or Controlled Environment: Which Option is Right?

When deciding between a cleanroom and a controlled environment, the primary considerations are (A) the application and (B) the industry involved.

Generally, when a project requires environmental controls for stable temperatures and humidity, a controlled environment is what you need. If the application requires contaminant levels to be less than a specific threshold, a cleanroom is necessary.

This commonly applies to industries using highly sensitive electronics or purified chemical substances. The most common industries and applications for cleanrooms include the following:

• Semiconductors & Microelectronics
• Military & Aerospace
• Hospital isolation rooms
• Biotech
• Pharmaceutical
• Medical device manufacturing

For most other laboratory environments, controlled environments are usually acceptable. For instance, a process control laboratory working with chrome plating depends on stable environmental controls, but not at the level of a cleanroom.

Other applications for controlled environments include the following:

• Biotech
• Mining
• Agricultural research and food production

Facilities sometimes use both a controlled environment and cleanroom. For example, a laboratory might perform quality control testing in a certified ISO class 8 cleanroom but store the materials in a controlled environment if they don’t need to be kept at strict levels of cleanliness.

Contact Air Innovations for Cleanroom Environmental Control Solutions

Deciding between a controlled environment vs. a cleanroom is not difficult once you’ve clarified your application. For cleanrooms, several industries have specific cleanroom standards, in addition to fundamental national and international standards. Contact Air Innovations to learn more about cleanroom air purification. Our air filtration engineers have continually advanced cleanroom HVAC systems, including our customizable HEPAir and AdvancAir systems. The Air Innovation product line is built for a wide range of industrial, laboratory, and specialized uses, and our knowledgeable service technicians are standing by to assist you.

How Sterile Storage Cabinets Protect Your Medical Supplies Through Multiple Levels of Functionality

Maintaining sterile storage conditions is necessary to protect medical instruments, drugs, surgical implants, and other equipment from contaminants. ARON guidelines on sterilization are straightforward: temperatures should not exceed 72℉ (22℃) to 78℉ (26℃), relative humidity should not exceed 60%, and airflow should be positive pressure with at least four total air changes per hour.

Hospital administrators and other end users should understand how sterile storage solutions have been designed to protect sensitive and often valuable medical supplies. This knowledge will enable them to select the best solution and know how to operate and maintain it for optimal performance.

Sterile storage cabinet in a hospital

How Sterile Storage Cabinets Preserve Sterility

Air Innovations has engineered a small modular sterile storage cabinet that can be deployed to hospital rooms, surgical facilities, or other medical facilities. Since the cabinet is much smaller than traditional autoclaves, it can be used in various locations. These sterile storage cabinets utilize multiple levels of functionality to ensure the equipment and sterilized packages are protected.

The first protective function is that all air in the cabinet recirculates through a HEPA filter at more than 250 air changes per hour—six times more than in a standard operating room. Any airborne viables in the cabinet are captured in the 99.97% efficient HEPA filter every 15 seconds. As an additional level of safety, an optional UV-C lamp can be installed above the HEPA filter to neutralize viruses or bacteria that may live on the filter.

Under most conditions, the sterile storage cabinet meets ISO4 cleanliness conditions. After opening the cabinet door, returning to this ultra-clean state takes less than five minutes.

The sterile storage cabinet’s second protective function is how it humidifies the cabinet space. The cabinet’s recommended use includes demineralized water, which has been treated to remove mineral impurities. The humidifier pulls water from the onboard storage tank and boils it to generate steam which is then injected into the storage cabinet. If bacteria or viruses were present in the water tank, they would be unable to live inside a boiling humidifier and could not reach the cabinet’s sterilized contents. The sterile storage cabinet’s humidifier has been programmed to boil until all the water is gone and the humidifier is dry after each  . This allows users to store sterile items at the correct humidity without the risk of contamination from the water source.

Lastly, the cabinet is positively pressurized to prevent particles from infiltrating the space when the door is not open.

Sterile Storage Cabinets vs Cleanrooms

Sterile storage cabinets offer several primary benefits over cleanrooms.

First, the modular design of the cabinets enables hospital staff to decentralize their sterile storage to be closer to points of use. Cabinets are also more affordable than cleanrooms, which means hospitals can utilize more than one at a time. If a cabinet malfunctions, only the product stored in it is at risk, whereas if a cleanroom goes down, all the product within that space may be lost or need to be sterilized again. A backup sterile storage cabinet can be deployed quickly and easily in the same area. Lastly, people carry the greatest risk in a sterile environment. Hospital staff frequently access cleanrooms, where cabinets inherently isolate sensitive medical devices and products away from people.

By storing valuable medical supplies in cabinets designed to meet rigorous air purification standards and use humidity and positive pressure to ensure sterility, hospital administrators and staff will have peace of mind to focus on what they have been trained to do: treat patients and save lives. Download the sterile storage cabinet datasheet to learn more.