Clean Rooms Explained!!

Clean Rooms

Definition:

1. A clean environment designed to reduce the contamination of processes and materials. This is accomplished by removing or reducing contamination sources.
2. Federal Standard 209E (FS209E) defines the cleanroom as a room in which the contamination of airborne particles is controlled to specified limits.
3. British Standard defines the cleanroom as a room with control of particulate contamination, constructed and used in such a way as to minimize the introduction, generation, and retention of particles inside the room and in which the temperature, humidity, airflow patterns, air motion, and pressure are controlled.
4. Room with air containing no more than “n” particles per cubic foot equals to or is larger than 0.5 microns. Where, “n” is 1, 10, 100…

  Purpose of Clean Room Protocol:

• Performs and promotes successful cleanroom operation.
• Ensure safety in the clean environment.
• Provide operational conditions that meet process and user needs.

Perspective:

• The protocol provides basic awareness and general guidelines for cleanroom user.
• Successful clean room operation relies on each users understanding, participation, and self-discipline.
• The success of each user relies on trust, understanding, and shared responsibility among all users.

Principles of Clean Rooms:

1. Air is highly filtered (99.99% @ 0.3 microns). HEPA – High-Efficiency Particulate Air.
2. The layout should minimize particle source in a filtered air stream.
3. Airflow should remove most particles generated by a process.

Dos of Clean Room:

• An only authorized person should be allowed inside.
• Only take what is necessary.
• Only dedicated tools are allowed.
• Gown yourself in a prescribed manner over your non-frayed, non-ripped, and low lining clothes.  
• Always make sure that all the hairs are perfectly covered in the room including head and facial hairs.
• When taking the air shower, turn at least three times around in the on cycle time.
• Keep doors from clean room to gowning area closed.
• Keep the clean garments closed at all times when inside.
• Maintain good air management – PRODUCT GETS AIR FIRST.

Don’ts of Clean Room:

• People who do not fulfill the criteria to enter the cleanroom shouldn’t be allowed inside.
• The only cleanroom approved things are allowed inside.
• No bare clothes are allowed.
• Don’t expose any part of your body in the clean environment.
• Don’t open the door to the clean room until the on-cycle of the air shower isn’t over.
• Using doors to pass objects from one room to another is an offense. Use pass-through instead.
• No running around business is allowed in the clean room.
• Avoid making noise.

Types of Contaminants:

1. Particulate: dust, skin, hair, oil, makeup etc…
2. Chemical: oil, grease, metal, ions, perfume, etc…
3. Biological: bacteria, fungi, rodents, UV radiation, etc…

Cause of Contaminants:

• People: 75%
• Ventilation: 15%
• Room Structure: 5%
• Equipment: 5%

Where are clean room used?

• They are used in every industry because even a small particle can adversely affect the manufacturing process.
• Mainly used in semiconductor industry, biotech industry, pharmaceuticals, medical devices, aerospace, optics, military, and department of energy.

  ~Jay Mehta

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