Clean Rooms In Pharmaceutical Manufacturing
A Clean- Room is an environment in which several parameters (like Contamination, Pressurization, Temperature & Humidity and Personnel Access) are controlled, monitored and maintained. Basically Clean- Room is an area in which the Quantity & Size of Air- borne particles are controlled in order to limit contamination.
– It is constructed & operated in a manner to control the Introduction, Generation & Retention of contaminates inside the space. Filtered air flows into the rooms through High Efficiency Particulate Air (HEPA) filters. Clean- Rooms are classified on the basis of; the amount of air- borne particles load in the room in any given time.
What is Contamination?
“Contamination is anything that can corrupt a process or render product purity by either touching or mixing with it”
A) Common Contaminants Include:
- Solids/ Liquids/ Gases.
- Organic & Non- Organic Matter.
- Air- borne & Surface Particles.
- Static Charges +/_.
B) What Causes Contamination?
- People are primary source of Contamination:
Examples –
Skin flakes and oil.
Spittle.
Hair.
Perspiration.
Clothing Debris.
2. Materials also generate Contamination:
Examples-
Duct tape.
Cardboard.
Pencil.
Dry Wall.
Paint.
C) How Clean- Room Contamination is measured?
Ans: It is measured by the amount of Air- Borne particles present within a cubic foot of air. Particles are measured in microns (μm). A micron is equal to 1/1,000,000 of a meter or about .00004 inches.
| Relative Size of a Micron | |
| Strand of human hair | 50-70 microns |
| Regweed | 17-23 microns |
| Dust with Mite Feces | 10 microns |
| Pollen | 30 – 50 microns |
Important Point: Clean- Rooms are classified by the amount of micron size particles in one cubic foot of air.
Clean- Rooms are classified under the ISO Standard 14644:
– The classification is based upon the amount and size of air- borne particles in a Clean- Room in any given time.
– The ISO Standard covers 9 classes of Clean- Rooms with Class-1 being the Cleanest and Class 9 being the least clean
– ISO 5 Clean- Rooms are much cleaner than ISO 7 Clean- Rooms and more precautions to be taken to limit contamination.
– In 2001, ISO 14644-1 replaced Federal Standard 209 E as the basis for Clean- Room Classification; where Federal Standard 209 E measured 0.5 μm particles and larger. ISO 14644-1 takes into account even smaller air particles- providing a more precise basis of measurement.
– ISO 14644-1 classifies a Clean- Room based on the amount of particles ranging from 0.1 μm to over 5 μm per cubic meter (m3) of air.
ISO 14644-1 Clean- Room Standards
| CLASS | Maximum Particles/ m3 | ||||||
| ≥ 0.1 μm | ≥ 0.2 μm | ≥ 0.3 μm | ≥ 0.5 μm | ≥ 1 μm | ≥ 5 μm | ||
| ISO 1 | 10 | 2.37 | 1.02 | 0.35 | 0.083 | 0.0029 | |
| ISO 2 | 100 | 23.7 | 10.2 | 3.5 | 0.83 | 0.029 | |
| ISO 3 | 1,000 | 237 | 102 | 35 | 8.3 | 0.29 | |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | 2.9 | |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | |
| ISO 6 | 1.0 x 106 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | |
| ISO 7 | 1.0 x 107 | 2.37 x 106 | 1,020,000 | 352, 000 | 83, 200 | 2,930 | |
| ISO 8 | 1.0 x 108 | 2.37 x 107 | 1.02 x 107 | 3,520,000 | 832, 000 | 29, 300 | |
| ISO 9 | 1.0 x 109 | 2.37 x 108 | 1.02 x 108 | 35,200,000 | 8,320,000 | 293,000 | |
– For Instance, Nano- Technology & precision micro- electronics industries often require tight control of the amount & size of air- particles in the air as well as:
- Temperature
- Humidity
- Electrical Conductivity.
- Electromagnetic Interference.
- Cleanliness of Interior Component and more…
Conversely, an enclosure to house a co-ordinate measuring machine may only require slightly cleaner air than that of an average room, as well as temperature and humidity control.
– Therefore, different classes of Clean- Rooms exist to donate how “clean” an environment has to be.
– Many “Clean- Rooms” do not need to meet any standards, but exist to improve product yield, protective sensitive equipment or control pressure.
– If individual require an ISO 3 Clean- Room or just need to control an environment, PortaFab can help to accomplish an individual’s goal.
– PortaFab offers 3 distinct modules Clean- Rooms systems:
- Clean Line.
- Fab Line.
- Pharma System.
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