Cleanroom, laboratory garments, wearing/donning

4th May 2006

The primary purpose of building a cleanroom or laboratory is to create an environment superior to "street level" in terms of particles, sterility and other forms of contamination. This often represents a significant investment in buildings and manpower. To maintain this controlled environment it is therefore important to provide protection from the greatest source of contamination, people and their clothing. By far, the largest number of particles released from the operator is skin flakes, varying in size from a few micrometers to between 40 and 50 μm with a median size of 20 μm. In moderate motion, between 500,000 and 1,000,000 skin flakes may be released per minute, with subsequent disintegrations in the air stream rapidly doubling or trebling this number. Bacteria-carrying skin cells typically released from males number 1,000 per minute, with less dispersion from females. Barriers and protection begins in the gowning area which should meet the same standards as the cleanroom or laboratory itself. The proper choice of protective clothing and other garb [Recommended cleanroom clothing]* is very important as is correctly donning, ensuring the controlled environment will not be soiled.

Guidelines; Steps through a properly organized gowning room.

Entering cleanroom, laboratory.

1. Secure lockers for street clothing and personal property
2. Shoe cleaner, with rotating brushes to remove contaminants from street clothing.
3. Walk on adhesive tacky floor mats.
4. Air shower with HEPA filtered air jets to remove loose contaminants on under clothing.
5. Hand washing, non-touch operation.
6. Hand dryer, HEPA/ULPA filtered air, non-touch.
7. Dispensers for gloves or glove liners
8. Glove wash and dry if not already cleanroom approved
9. Headwear dispenser.
10. Face mask dispenser
11. Waste receptacle for packing, these should be present where items are unpacked.
12.  Garb up, garments storage, closed cabinet with filtered air flow or open rack for re-usables, shelves for disposables.
13.  Waste receptacle.
14. Support rails for operators to lean against.
15. Bootie or shoe cover dispenser
16. Waste receptacle
17.  Step-over bench, to fit shoe covers.
18. Mirror to check correct clothing.
19. Safety glasses
20. Final Air shower to remove any remaining particles.

Leaving cleanroom, laboratory.

1. Garment hamper for reusable garments to be laundered.
2. Waste receptacle for all disposables.

Be sure your operators are sufficiently trained in the need for these procedures. A violating garment does not set of alarm bells and it is not possible to provide constant supervision.

Choose the appropriate type of clothing and changes for your controlled environment.

*Recommended cleanroom clothing

The following rules may help reinforce the message;

Don't touch. Most cleanliness violations occur when garments are touched by dirty hands or they touch the floor.

Dress from the head down. That way released particles wont fall

on clean garments or booties.

Understand garment design. In most instances gloves and booties are worn over coverall sleeves and cuffs and hoods are tucked inside collars. Provide a mirror for operators to check next to "how to" photo guide.

Minimize motion. Changing room design should always pro

vide the least operator motion and shortest route through until the final fully clothed stage.

Maintenance. Ensure someone is responsible for replacing disposable items such as face masks, gloves, tacky mats etc regularly. Set up a properly controlled garment laundry process.  Where possible set up automated process for cleaning shoes etc, these may be more expensive in the beginning but reduce dependence on human activity and pay for themselves in the long run.

Train and reinforce. Quality cannot be added later, it needs to be built in by the adoption of the correct gowning protocols, training and auditing procedures.