Clean Rooms In Pharmaceutical Manufacturing

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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.

Cleanroom1

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?

  1. 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.

Cleanroom2

Cleanroom3

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.
Cleanroom4Cleanroom5– 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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