- ISO-14644-1 Test Record
A room in which contamination of airborne particles is controlled and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters, eg. Temperature, humidity, and pressure are controlled as necessary.
- FED STD 209E
A room in which the concentration of airborne particles is controlled and which contains one or more clean zones.
A define space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class.
ISO Class 4 Cleanroom
352 airborne particles at 0.5µm size within a volume unit of 1m².
Federal Standard Class 10 Cleanroom
10 airborne particles at 0.5µm size within a volume unit of 1ft².
- As Built
A cleanroom (facility) that is complete and ready for operation with all the services connected and functional but without equipment or personnel in the facility.
A cleanroom (facility) in normal operation with all services functioning and with equipment and personnel, if applicable present and performing their normal work functions in the facility.
- How to keep cleanroom clean?
Influencing factors that can harm the product/ process. Operator
- Particulate and Gaseous Contaminants
- Environmental factors eg. Vibrations, heat, rain ducts.
Particulate and Gaseous Contaminants
- Cleanliness of Air
- Cleaning of surface of working place
- Dead and Living particles
- Inert and toxic particles
- List of possible Air Contaminants in a clean room
- Aerosols – No hairspray /perfume
- Contaminants- Environmental Factors
- Temperature of air
- Humidity of air
- Electro Magnetic Disturbances (EMD)
- Electrostatics Disturbances (ESD)
- Major Equipment
- Laminar Air Flow
- HEPA Filter
- High Efficiency Particulate Air Filter (HEPA) Filter
- A HEPA Filter is defined as having a minimum efficiency in removing small particles ( approx. equal to 0.3µm) from air of 99.7%
- ULPA Filter
- Ultra Low Penetration Air Filter (ULPA) Filter
- A UPLA filter is defined as having a minimum efficiency in removing small particles (appro equal to 0.1µm ~ 0.2µm) from air of 99.999%.
An agent of biological origin that has the capacity to produce deleterious effects on humans, i.e. micro-organisms, toxins, and allergens derived from those organisms; and allergens and toxins derived from higher plants and animals.
- BioSafety (definition)
The application of combinations of laboratory practice and procedures, laboratory facilities and safety equipment when working with potentially infectious microorganisms.
- Biosafety Level (BSL)
- BSL1 – agents not known to cause diseases.
- Suitable for work involving well-characterized agents not known to cause disease in healthy adult humans and of minimal potential hazard to laboratory personnel and the environment
- BSL2 -agents associated with diseases.
- Suitable for work involving agents of moderate potential hazard to personnel and the environment
- BSL3-indegious /exotic agents associated with human diseases and with potential for aerosol transmission.
- Suitable for work with infectious agents which may cause serious or potentially lethal disease as a result of exposure by inhalation route.
- BSL4 – dangerous / exotic agents of life-threatening nature.
Suitable for work with dangerous and exotic agents that pose a high individual risk of aerosol- transmitted laboratory infectious and life threatening disease.