Prevention and Minimizing Contamination in a Clean Room. - Coggle Diagram
Prevention and Minimizing Contamination in a Clean Room.
A rectangular shape is easiest to accommodate, other shapes may be incorporated into the facility as long as appropriate attention is paid to airflow patterns.
Airlocks or AnteRoom
This is a room between the cleanroom and less clean area surrounding the cleanroom.
The purpose of the room is to maintain pressurization differentials between spaces of different cleanliness class.
Windows are recommended in cleanrooms to facilitate supervision and for safety, unless prohibited by the facility protocol for security reasons
Windows should be placed to permit viewing of operations in order to minimize the need for non-cleanroom personnel to enter the cleanroom.
A pass-through airlock should be provided for the transfer of small articles from uncontrolled areas into the cleanroom or between areas of different cleanliness class.
The pass-through may include a speaking diaphragm, intercom, or telephone for communication when items are transferred, and interlocks to prevent both doors from being opened at the same time.
Should be designed to support the garment protocol established for the facility.
Clean and disinfect floors, walls, ceilings, trolley and all exposed surfaces to minimize contamination from surface dirt
Use adhesive cleanroom mats and flooring.
Ensure that raw materials, containers and packaging are manufactured to comply with producing minimal amounts of contamination.
Two types of air flow systems are typically employed in cleanrooms which is laminar air flow and turbulent air flow.
In laminar air flow, air flows in parallel straight lines with little disruption. Air is usually directed downwards or horizontally, and the layout of the room is designed so that turbulence is minimized.
Turbulent air flow systems are used in situations where laminar flow would generate airflow dead zones that are unavoidable due to necessary equipment or the layout of the room.
High-efficiency particulate air (HEPA) filters are used to remove dust and other contaminants, ensuring that the air quality remains extremely high. Positive pressure is also often employed in the event of leakage, such that the direction of air flow will be from the cleanroom to the outside.
Positive Air Pressure Cleanrooms normally operate in an air pressure range of 0.02 in. to 0.2 in water column (H20). Positive air pressure means the cleanroom or rooms are "pumped up" with more filtered air then the surrounding space outside the cleanroom(s).
There are different cascading levels of positive air pressure from the cleanest rooms at the highest pressure down to the gown room/or airlock room.
Always Practice Good Hygiene
Employees have to practice good hygiene and for managers of controlled environments to establish and enforce uniform hygiene recommendations.
A quiet cleanroom doesn’t just boost productivity; it also has the power to reduce contaminants. Consider the fact that loud speaking of just 100 words can produce up to 250 particles of saliva.
The more rapidly movement occurs inside the cleanroom, the more particles will be given off. To combat excess contamination, employees should move slowly and deliberately as they approach work stations. They should also be encouraged to enter and exit cleanrooms slowly.
Ensure that personnel wears cleanroom garments that cover their mouth, hair, clothing, and skin. Cleanroom garments and gloves minimize contamination from people, and their clothing.
Hoods are tucked inside of coveralls.
Put on cleanroom booties.
Put on cleanroom gloves.
Apply coveralls, only touch the floor on the clean side of a gowning bench .
Ensure that booties and gloves overlap the coveralls.
Apply a freshly laundered cleanroom hood.
Wipedown the gowning bench with a clean, sterile wiper.
Apply cleanroom bouffant (beard covers for those with facial hair).
Use cleanroom mirror for self-check.
Wash or apply alcohol solution to cleanroom gloves.
Put on cleanroom gloves.
Apply alcohol solution to outside of liners.
Put on cleanroom glove liners.
Wash hands thoroughly (use waterless alcohol solution for USP 797).
Don cleanroom bouffant.
Don shoe cover booties.
Use a shoe brush cleaner.
Before entering gowning room taking at least three small steps with each foot; remove dirty sticky mat layer if needed.