Class 10000 Clean Rooms

A class 10000 clean room refers to United States Federal Standard 209. It classifies clean rooms from 1 to 100000, with a classification of 1 having the highest standards and 100000 being the least restrictive standards. Clean rooms are classified according to the number of particles they contain per cubic meter. Particulate matter in a clean room is measured in microns, one-millionth of a meter or micrometers, a measurement that is so small that it is beyond normal human vision.

Clean rooms are scientifically engineered enclosures designed to perform highly sensitive research and fabrications. The restrictive and controlled conditions of a clean room protect the items being studied, which can easily be contaminated by the smallest pieces of dirt, dust, or microbes. For this reason, strict controls and close adherence to air quality and the type of apparel workers wear are required.

The Elements of a Clean Room

The design of clean rooms involves strict control of the atmosphere, including the walls, air handling, floor, ceiling, windows, lights, and doors. The components' selection and quality are a few determining factors regarding a clean room's classification.

Class 10000 clean rooms are one of the least restrictive clean rooms and are allowed to have a particulate count of 352,000 particles of 0.5 microns or more per cubic meter. Unlike more restrictive clean rooms, where workers have to wear bunny suits and face masks, workers in a class 10000 clean room are allowed to wear their own clothing with coverings for their shoes and hair, face masks, gloves, and lab coats. Gloves are made of synthetic materials such as latex or nitrile and are usually worn once and discarded.

Air Filtering Unit

The discussion of any clean room begins with the air handling units with high-efficiency particulate air (HEPA) filters, which can remove 99.99% of all particulate matter. Air handling units can be located in the ceiling or walls with vents in the ceiling, walls, or floor.

Lighting

Like all aspects of a clean room, lighting must be tightly sealed to protect against the infiltration of bacteria or particles. LED lighting is preferred. Lights can be changed from outside the clean room to maintain the room's integrity with the ballast mounted inside the lighting housing.

Entryways

For class 10000 clean rooms, doors and entryways come in various widths and heights to fit the room's needs. They can have windows, and doors can be automatic, sliding, or motorized. In some cases, double doors enhance the quality of a class 10000 clean room.

Also included in class 10000 clean room design are pass thrus that allow the transfer of uncontaminated materials in and out of the room. They are smaller than entryways and resemble a cabinet placed in the wall of a clean room. Pass thrus are a convenient way to place items in the room without following all the entry protocols.

Ceiling Grid

The ceiling grid hangs by steel wires from the structure of the building where the clean room is located. The tiles for the ceiling grid are made of tightly sealed materials designed to fit securely into the grid to prevent external contamination.

Walls

The type of walls for a class 10000 clean room varies regarding the materials used. In all cases, the walls are panels made of vinyl, high-pressure laminates, fiberglass reinforced plastic, or coated steel or aluminum. The key to the strength of clean room panels is their core, which can be polystyrene, gypsum, or isocyanurate.

Specifications for a Class 10000 Clean Room

For every type of clean room, there are standards that give it its designation and are the key to its classification. The initial cleaning of air is not very difficult and can be easily completed. It simply requires passing outside air through the filtration system. The greater challenge is keeping the air clean and maintaining the constant flow of fresh, clean air.

The standard for determining a clean room's classification is its air change rate, or ACR, which refers to how rapidly the air in the room is removed and replaced with filtered fresh air. For example, a class 10000 clean room must have an ACR of 45 to 60 air changes per hour.

Uses for Class 10000 Clean Rooms

As technology has grown and products become more complex, clean rooms have become essential to the production process. The standards for class 10000 clean rooms have made them one of the more widely used classes of clean rooms. The industries below require contaminate-free environments for the safe production of their products and to guarantee product quality and performance.

• Medical device manufacturing
• Electronics manufacturing
• Pharmaceutical compounding
• Laboratories
• Aerospace product development
• Cosmetics production