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TOP 10 CONCERNS WHEN CHOOSING CLEAN ROOM SUPPLIES

May 16th 2013

Cleanrooms are defined as a controlled environment with regards to airborne particles. The modular cleanroom can also have ESD, Non Outgassing, and Sterile requirements. When choosing the correct cleanroom supplies each requirement must be taken into consideration.

1) Just because the box says “Cleanroom” or “Lint Free” does not mean that it is true. Testing should be performed, Certificate of Conformity or an independent test data sheet be supplied with the cleanroom supplies.

2) Cleanroom wipes, gloves and other supplies should be double bagged for Class 10 and
Class 100 environments.

3) Lowest priced products do not mean lowest cleanliness level.

4) When the cleanroom environment has outgassing concerns testing should be performed on the wipes and gloves to ensure they don not contain silicon or will leach contaminants. Is the mold release agent still on the glove?

5) Are the cleanroom supplies manufactured and packaged in a cleanroom? Or is the product manufactured in a standard factory environment and brought into a cleanroom for packaging?

6) Proper gowning procedures for the correct Class of cleanroom need to be followed. A cleanroom frock would be an appropriate garment for a Class 100,000 cleanroom but would not provide adequate containment of particles for a Class 100 cleanroom. The disposable garments should arrive bagged and not packaged directly in a cardboard box.

7) Cleaning supplies such as mops, buckets and cleaners should be chosen so additional contaminates aren’t introduced into the cleanroom. So often thousands if not millions of dollars are spent on the construction of a new cleanroom and no thought is given to the proper cleaning supplies. Will the cleanroom cleaner leave a residue? Will the mop head shed particles? Is the bucket, wringer and handle made of material that will not corrode? Just the motor of a vacuum cleaner can produce 100,000 particles when running. Does the cleanroom vacuum cleaner have the HEPA filter after the motor so the motor particulates do not enter the cleanroom?

8) When choosing wipes for a sterile cleanroom environment there are five choices. First a standard non sterile poly/cellulose or polyester wipe. Second a gamma irradiated wipe which would have a Certificate of Irradiation. For an aseptic environment there are non woven poly/cellulose or knit polyester wipe Validated Sterile. These wipes would have a Certificate of Irradiation which documents it went through the gamma irradiation process plus a Certificate of Sterility. A third party has tested the wipe to ensure sterility. The fourth style of cleanroom wipe is an ultra low endotoxin or pyrogen free wipe. Wipes have two levels of endotoxin testing: medical device and another for the most critical applications where implantable materials, pharmaceuticals and surgical instruments are manufactured. The first wipe has an Endotoxin Free Certificate and the second wipe has the Endotoxin Free Certificate plus Validated Sterile. The final option would be to choose a presaturated sterile wipe. These presaturated wipes are available with IPA, Ethanol, Cleaning Agent, Sodium Hypochlorite, Hydrogen Peroxide, and Stainless Steel Cleaner. Other important qualities in wipes: absorbency, cleanliness, resist wear and tear, and chemical compatibility.

9) Not all products can be autoclaved. Autoclaveable cleanroom garments will require a metal zipper vs the standard plastic. Carts and racks should be ordered with autoclavable casters and metal split sleeves. Check autoclave compatibility before ordering the cleanroom products.

10) When ESD is a concern does the product have a topical antistatic coat or does the product in itself have static controlled properties? If the table mat is wiped down with a cleaning agent will it remove or reduce the effectiveness of the mat? Conductive bins will loose the static control properties over time and should be tested periodically to ensure they maintain the proper ESD level. The carbon fibers in ESD garments will break down when washed and will need to be replaced periodically. Choose fabric with higher levels of carbon with 2% or 4% for higher static dissipation rate.

Cleanroom supplies require proper testing and evaluation to ensure additional particles are not introduced into the controlled environment. Call Western States Sales or go to the web site www.CleanRoomWorld.com to get guidance on choosing the right cleanroom supplies.

Cindy Weist
Western States Sales Inc
www.CleanRoomWorld.com

About Cleanroom World:

Cleanroom World is a cleanroom specialist in Centennial Colorado
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