Glove Selection for Controlled Environments
This article is based on an original publication by Kimtech.
Making a change or planning to upgrade cleanroom gloves should never be taken lightly. The right decision should be made taking the proper time and consideration – because the wrong product could mean thousands or even millions of dollars in rejects and recalls.
Hand Analysis & Risk Assessment
Typically worn to protect operators from everyday hazards in a "dirty" manufacturing environment, gloves help to safeguard against chemicals, temperature, and surface or handling hazards. Also used in cleanroom settings or other controlled environments, gloves can protect against contamination alongside other personal protective equipment (PPE) including gowns, footwear and masks.
In any clean environment, critical control points must be identified in light of potential contamination sources:
- When stationary, a person can generate approximately 100,000 particles of contamination, rising to 5 million particles when on the move.
- The average human body is contaminate with 32 million bacteria per square inch.
- Humans shed about 30,000 to 40,000 dead skin cells per minute
- Each square inch of the hand is home to approximately 10,000 microorganisms
With a clear understanding of the allowable level of particulates, extractables and non-volatile residues, a proper risk assessment process can be performed including both microbiological and particulate control.
Generally constructed of vinyl, natural rubber latex or nitrile, each cleanroom glove material has both advantages and drawbacks.
- Vinyl: Typically clean, cost-effective and static dissipative, vinyl gloves offer poor heat retention and moisture vapor transmission.
- Natural Rubber Latex: Durable and cost-effective, this material is also known to cause allergic reactions and is not inherently static dissipative.
- Nitrile: A preferred material due to high puncture and chemical resistance, nitrile also offers good static dissipative characteristics.
Key Performance Factors
During cleanroom glove selection several factors must be taken into consideration. For instance, the glove's particle and extractable counts should be carefully evaluated, alongside their compliance with AAMI, ASTM and EN standards and regulations. The gloves must be designed for durability in the cleanroom and should be evaluated for ESD-resistant characteristics. Comfort can also dramatically influence the selection process.