1. ISO-14644-1 Test Record

Cleanroom (Definition)

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.

2. FED STD 209E

Cleanroom

A room in which the concentration of airborne particles is controlled and which contains one or more clean zones.

Clean Zone

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.

3. 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.

4. Operational

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.

5. 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

6. List of possible Air Contaminants in a clean room

• People
• Gases
• Chemical
• Aerosols – No hairspray /perfume
• Equipment

7. Contaminants- Environmental Factors

• Temperature of air
• Humidity of air
• Vibrations
• Noise
• Radiation
• Ionisation
• Electro Magnetic Disturbances (EMD)
• Electrostatics Disturbances (ESD)

1. Major Equipment
2. • Laminar Air Flow
3. 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%

2. 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%.

3. BioHazard(definition)

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.

4. BioSafety (definition)

The application of combinations of laboratory practice and procedures, laboratory facilities and safety equipment when working with potentially infectious microorganisms.

5. 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.