Fundamentals of Medical Clean Room (1) - Guangzhou C&H Medical Co.,Ltd.

Hospital Engineering

Fundamentals of Medical Clean Room (1)

I. Glossary and Definitions

Micron: More properly, micrometer; A length equal to one millionth of a meter, often written μm;

Angstrom (A): Unit of length, 1A=1x10^-10M, 10000A=1μm;

HEPA Filter: Acronym for High Efficiency Particulate Air Filter, typical filter efficiencies of HEPA filters are 99.997%@0.3μm diameter;

ULPA Filter: Acronym for Ultra-Low Particulate Air filter, typical efficiencies for ULPA filter are 99.999997%@0.3μm diameter;

Particulate Contaminants: Solid particles in the 0.01 to 100μm size range;

AMC: Acronym for Airborne Molecular Contamination, chemical contamination that occurs upon exposure to airborne gases and vapors during product handling, storage and transport;

Ion: An atom or group of atoms carry a positive or negative charge as a result of having gained or lost one or more electrons;

FFU: Acronym for Fan Filter Unit, often with an HEPA/ULPA filter underneath;

Class: As defined in FED STD 209, international Standard ISO 14644 the number of particles found per volume of air;

Clean Zoom: A defined space in which the concentration of airborne particles is controlled to meet a specified airborne cleanliness class;

Clean Room: An enclosed area with control over airborne particles as well as other factors as needed (such as air velocity and direction, temperature, humidity, pressure, molecular contamination);

As-Built Clean Room: A clean room that is complete and ready for operation, with all services connected and functional, but without equipment of operating personnel in the facility;

At-Rest Clean Room: A clean room that is complete with all services connected functioning and with equipment installed and operable, as specified, but without operating personnel in the facility;

Operational Clean Room: A clean room in normal operation with services functioning and with equipment and personnel.

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