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Selecting the Proper Apparel for a Cleanroom Environment
By Donna McPherson Senior Category Manager, Protective Apparel Kimberly-Clark
Professional Safety Division
If you work in a cleanroom or sterile manufacturing environment, chances are you wear some sort of protective apparel on a daily basis. But are you wearing the best protective apparel for your job?
The task of selecting personal protective equipment (PPE) should be a team decision
involving lab managers, validation engineers, contamination control engineers,
quality control engineers, industrial hygienists and purchasing.
The key goal is to limit contamination – anything that is detrimental to yield,
productivity, cost, and reliability – of the process or product by people working
in the facility. Typical contaminants of concern include bacteria, hair, dead
skin cells, clothing fibers and even elemental contamination from sodium, potassium,
chloride and magnesium – all of which can be transferred from the human body.
Higher classes of cleanrooms need greater levels of contamination control. The
following chart lists minimum gowning requirements for different Cleanroom Classes.
Keep in mind when evaluating and selecting PPE that coveralls, gloves and other PPE accessories are not rated/approved for a specific class of cleanroom. The reality is there are no standards for determining the cleanroom class of a PPE item according to lint or extractable test results. In addition, these test results can be highly variable depending on the type of test and the laboratory equipment used.
Once you’ve narrowed your product selection down to the right group of products,
you can choose your PPE based on specific functional needs such as extractables,
lint, and ESD properties as well as fit, tactile properties, and material type.
Fit can be one of the trickiest issues; what works for a 6ft+ husky man may not
work for a 5ft petite woman. The key is to find a balance between a generous fit
that will allow a range of motion and a contoured fit that eliminates extra, billowy
material, which can cause contamination issues.
Electrostatic Discharge (ESD)
ESD is a particular concern in electronics and semiconductor industries. The
goal in controlling ESD is not to eliminate the charge, but to reduce and dissipate
it away from the product and to the ground in a controlled manner through the
use of wrist straps and static dissipative garments and gloves.
For gloves, the best test of dissipative performance is via In-Use Resistance
per ANSI ESD TR-03. Surface resistance testing is not appropriate for gloves because
the goal is to dissipate charge through the glove, not along its surface where
it can transfer the charge to other components. In-use testing shows both vinyl
and nitrile gloves to be static dissipative, having a surface resistivity between
105 and 1010 Ohms. Nitrile contains fewer particles
and contaminants that can cause potential damage to products and processes, making
nitrile the preferred material for cleanroom applications.
Managing Your PPE
click the image to enlarge
Chart lists minimum gowning requirements for different cleanroom
classes. Higher classes of cleanrooms need greater levels of contamination
control. |
At some point during the PPE selection process, you may be faced with the decision
of using a disposable garment or a launderable one. Keep in mind when evaluating
the cost of disposables versus reusables, that reusables often contain “hidden”
costs associated with managing distribution and collection as well as loss of
garment functionality due to degradation of performance (unraveling edges, thinning
of material, etc.). Another important caution with reusables is when people try
to get multiple wearings without laundering the garments. This can create additional
contamination issues relating to the continued “collection” of shedded skin cells
and other debris within and on the garment.
Another PPE management issue is sterility in packaging – a particular concern in the pharmaceutical industry, but also of concern in all cleanrooms for moving from one level of the environment to the next cleaner level. PPE should be packaged in such a way that users can extract the PPE from the package and don the PPE without compromising the sterile field. PPE manufacturers typically use multiple packaging layers that are shed as the product is moved from controlled areas to more critical areas. Removing each layer of packaging as the product is moved helps to reduce the possibility of contamination between different cleanliness areas. Look for products with four layers of packaging to allow for optimum transition cleanliness.
Pharmaceutical Processing
Advantage Business Media
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