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Published on 1 September 2007

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Setting the standards for cytotoxic glove protection. Are we asking the right questions? EN374-3(1) vs ASTM D 6978-05(2)

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Harry Kirk

Business Development Director
Nitritex Ltd
Newmarket
UK

E: sales@nitritex.com

Countless thousands of operators working in hospital pharmacies expose themselves daily to the dangers surrounding cytotoxics, especially when the gloves they use have not been tested to the latest, most relevant standard.

So who can provide superior quality gloves that not only remove latex allergy issues, but offer testing results that reflect more stringent in-use scenarios? The answer may be closer than you think.

Nitritex Ltd, a technology based UK manufacturer of gloves specifically designed for use in the chemotherapeutic market, has introduced its BioClean P-Zero, BioClean Ultimate and BioClean Emerald gloves, all of which have been tested to the ASTM D 6978-05 standard.

The performance of the Nitritex gloves far eclipses that of the glove market leader, supplied by a well-known, German-based company. This is despite the fact that the German brand is on average twice the thickness of the BioClean range of chemotherapy gloves.

In response to the hazardous nature and dangers involved in handling cytotoxic drugs, the new standard (ASTM D 6978-05) demands that the breakthrough of the drug is deemed to have occurred when the permeation rate has reached 0.01 μg/cm2/min compared with EN 374-3, which uses 1.00 μg/cm2/min as its testing level. ASTM D 6978-05 is therefore 100 times more stringent than its European counterpart.

The current standard by which the majority of gloves and garments are tested is EN374-3, which determines the resistance of protective gloves to permeation by chemicals and micro-organisms. While the EN374-3 offers some value in terms of safety determination, there are a number of key differences to be noted between the methodologies as outlined below.

The protection provided by gloves has become a key issue for operators working with cytotoxic drugs.

While EN374-3 is an acceptable standard for general chemicals protection, to ensure the greatest protection for handlers of cytotoxic drugs, it is essential that the ASTM D 6978-05 is adopted as the standard test method for chemo gloves.

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References
1. EN 374-3:2003 Protective gloves against chemicals and micro organisms. Determination of resistance to permeation by chemicals.
2. ASTM D 6978-05 Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.

For any additional queries relating to the testing methodologies and results discussed above please contact Nitritex Ltd on +44 (0) 1638663338 or email us at sales@nitritex.com and we will be happy to answer any questions you may have



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