What Makes a Cleanroom a Clean Room
A “clean room” is an area of a facility that is strictly controlled to reduce contamination particles and fibers, chemicals, bacteria or electrostatic charges. A clean room without proper contamination control, the contamination could adulterate a product being produced within the cleanroom or cause harm to people, equipment or production and is optimized to retain these particles within it to stop them from spreading into other areas of the facility.
While clean rooms are most prevalent in pharmaceutical and food production/manufacturing industries, they are becoming increasingly common in the production of medical devices, solar/alternative energy and lithium-ion battery production, all of which require strict quality controls.
Temperature, humidity and pressure can also be controlled in a clean room. That’s why they must be designed with a variety of features to reduce microbial growth, engineered with materials that can withstand environmental changes and have the ability to be cleaned frequently and stringently. A clean room will differ from other areas of the facility because operating personnel may be required to wear garments that serve to reduce particulate contamination.
Are there regulations involved in clean room operation?
Cleanrooms must adhere to protocols of various regulatory bodies specific to the industry. This includes:
Applying only to food facilities, overarching Sanitation Standard Operating Procedures (SSOPs) dictate that the clean room will prevent direct contamination or adulteration of whatever product is being produced, and the room is an integral part of the facility’s sanitary process control in its daily operations. Clean rooms should be designed with Hazard Analysis Critical Control Point risk assessment principles in mind, so that potential hazards or points of potential contamination can be easily pinpointed.
How to optimize clean room environment
Air flow and filtration
In all industries, cleanrooms use high-efficiency particulate air (HEPA) filters to remove particles larger than 0.5 μm (0.02 mils), as well as dilute chemicals and suppress bacteria. Rite Hite’s “The Essential Guide: Cleanrooms and Clean Areas” states, “the goal in most cases is to maintain an air pressure differential between rooms, pushing air from the opening’s cleaner side to the less-clean side.”
Clean rooms depend on generous air circulation and filtration, coupled with airflow to pressurize the room and ensure that no contaminated air flows outside the contained area. Rite-Hite manufacturers HVLS industrial fans to cut down on humidity, moisture and bacteria in areas outside the clean room. HVLS fans slowly circulate a large amount of air as the air is pulled from above the fan and pushed down in a conical shape to the floor below, making it easy for warehouses and other structures to control airflow in various areas and processing bays. Rite-Hite’s direct drive fans are also ideal because they do not require oil to operate, helping to keep clean rooms free from fuel contamination..
Clean Room Doors
The FDA’s Food Safety Modernization Act (FSMA) warns of tight sanitation measures that call for fully separated processing spaces, especially in the ready-to-eat (RTE) food sector where raw and precooked products should never touch. In the pharmaceutical industry, facilities with sterile compounding activities must follow USP 797 regulations, and “modular” cleanroom construction is increasingly common, wherein cleanrooms are constructed with the same material as the adjoining facility walls to minimize seams where particles can settle.
Built to aid these regulations, Rite-Hite’s clean room doors contain lightweight, non-corrosive Lexan and UHMW side frames that can be easily removed for thorough cleaning. They are designed to meet or exceed the U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA) standards for washdown and bacteria control.
Rite-Hite offers fabric and wash-down curtain walls for non-insulated or higher-traffic areas. Fabric curtain walls can be trimmed around conduit, piping, ductwork, etc. They can be anchored to the floor to withstand pressure differential across them as filtration takes place.
Zoneworks®️ SCW Wash-down Curtain Wall is constructed of 18-ounce white vinyl fabric, with air- and water-tight heat welded seams and double slide rail panel-to-panel connections, eliminating the potential for bacteria, mold or mildew to accumulate. All components and fasteners are made of corrosion resistant stainless steel, and optional Clean Track system available to eliminate the potential for accumulation of bacteria, mold or mildew.
Your facility can be easily optimized to meet all requirements of a clean room. Rite-Hite can help you manage any contamination risks, our efficient equipment help keeps sanitation costs low, and we can guide you in navigating GMP standards to help your facility stay compliant and safe.