Natural rubber latex gloves are used across many cleanroom environments. The flexibility of latex gloves gives wearers the comfort and dexterity they need to perform tasks with the precision required in most cleanroom manufacturing activities. But despite the comfort and dexterity benefits, natural rubber latex presents significant risks.
Latex sensitivity affects up to 6% of the general population1 and can result in irritant contact dermatitis, allergic contact dermatitis or latex allergy. In some individuals, exposure to latex allergens can trigger a life threatening Type I allergic reaction.2
Pharmaceutical companies implement latex-free policies to prevent the risk of latex allergens contaminating product and potentially harming patients. In the microelectronics industry, the high electrical resistivity of latex gloves3 creates a risk of electrostatic discharge (ESD) that can damage products, costing many times more the annual expenditure on gloves.
Nitrile cleanroom gloves are the most common alternative to latex gloves. Nitrile is synthetic, eliminating the risk of latex sensitivity. The material’s lower electrical resistivity reduces the risk of ESD. It is also resistant to permeation by a wider range of chemicals, and can therefore provide better chemical protection than latex.4
The benefits of nitrile gloves over latex explain why many cleanrooms have moved away from the use of latex gloves. However, latex gloves are still the preferred choice in some cleanroom applications.
For example, the practice of double gloving in sterile pharmaceutical manufacturing leads many users to prefer sterile latex gloves, because double gloved sterile nitrile does not provide the same comfort, dexterity and tactile sensitivity as double gloved sterile latex.
Gloves are a key piece of equipment in the cleanroom, because contamination control is crucial to the productivity, quality and yields of a clean manufacturing process. For this reason, cleanroom glove selection can be both a time- and resource-intensive process. Selecting an alternative to latex cleanroom gloves requires successfully addressing all of the key considerations that affect cleanroom gloves. These can be summarised into four groups:
Health & safety: Chemicals, cytotoxics, micro-organisms, irritation and allergy
Contamination control: Particles, extractables, residues, bioburden, sterility, and endotoxins
Functionality: Tensile strength, comfort, fit, dexterity, tactile sensitivity, grip, cuff, donning, double gloving and packaging
Compliance: 89/686/EEC, ISO 9001, ISO14644-1, EU GMP, traceability, training, environment and global consolidation.
The importance and relevance of these considerations will depend on the industry, type of cleanroom and type of activity. There may be other considerations not listed that are unique to a specific application or company policy.
For manufacturers of cleanroom gloves to help their customers be successful in switching away from latex gloves, they must offer products and services that help them to address all of these considerations.
With this in mind, Kimberly-Clark has developed the Kimtech Pure Sterling Nitrile range of cleanroom gloves and the Contaminomics Programme.
The new range of gloves includes, for example:
- Kimtech Pure G3 Sterile Sterling Nitrile Gloves for ISO 5 Grade A cleanrooms.
- Kimtech Pure G3 Sterling Nitrile Gloves for ISO 3 or higher cleanrooms.
- Kimtech Pure G5 Sterling Nitrile Gloves for ISO 5 or higher cleanrooms.
Sterling is a proprietary nitrile technology from Kimberly-Clark that delivers a stronger, leaner and more flexible glove than traditional nitrile, while retaining its barrier protection.5 Sterling technology blends the protection of nitrile with the feel of latex.
The Contaminomics Programme is a comprehensive package of tools and services that allows us to partner with clean manufacturing customers to address all of their requirements for cleanroom glove selection and use.
References
1 Latex Allergy Support Group www.lasg.org.uk
2 EM Warshaw 1998. Latex Allergy. Journal of the American Academy of Dermatology 39:1
3 www.esdjournal.com/techpapr/esdclean/esdcln.pdf
4 www.contaminomics.com/products/chemical-permeation
5 www.contaminomics.com
