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First, let’s remind ourselves and understand the EU standards relating to disposable gloves: In February 2020 the ISO 21420:2020 standard came into force superseding EN 420:2003+A1:2009 and thus becoming an international standard. As everyone might know, this norm relates to the new general requirements for protective gloves. This new standard applies to PPE gloves (reusable gloves and disposable gloves) used in the laboratory and cleanroom workplaces. It is the responsibility of manufacturers of disposable gloves, such as latex gloves or nitrile gloves, to ensure that their PPE gloves are compliant with this new standard. The ISO 21420:2020 Standard “specifies the […]

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Regulation (EU) 2016/425 – ISO 374-1:2016+A1:2018 – ISO 375-5:2016 In April 2016, a new European regulation on Personal Protective Equipment (PPE) was adopted. In its wake has come a revision to some standards, including those relating to protective gloves offering protection to chemical and biological risks. Not only are nitrile gloves and latex gloves for use in the laboratory impacted, but also ultra-clean gloves for the pharmaceutical or high-technology industries. Looking at these changes, can we really talk about a revolution? The legal framework:PPE Regulation (EU) 2016/425 was passed in 2016 and came into force in April 2018. It has […]

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It is generally acknowledged that RNA is more prone to degradation than DNA, which may be because of the ubiquity and robustness of RNases. Accordingly researchers wishing to maintain an RNase-free environment may need to be more vigilant. Whilst human skin has long been recognised as a source of RNase contamination, simply wearing gloves may not provide a suitable barrier. This is because either the gloves have become contaminated by human contact or the cleanliness of the glove is not sufficient to ensure that they are RNase-free. Accordingly here are some tips for gloving in an RNase-free environment: 1) As […]

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DOWNLOAD FULL ARTICLE Am I using the right gloves for protecting myself AND the product? In the busy environment of the hospital pharmacy, you can be forgiven for feeling confused about what criteria to use for selecting nitrile gloves when handling cytotoxic agents. The bewildering display of standards and pictograms only increases the complexity. However the hazardous nature of many cytotoxic drugs is widely recognised and therefore it is incumbent on employers to undertake the necessary risk assessment to ensure that employees are protected. To facilitate this process the following checklist may help to ensure that personnel enjoy the highest […]

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Useful links related to nitrile gloves, latex gloves, laboratory gloves and cleanroom gloves European Committee for Standardisation www.cen.eu FDA Food and Drug Administration www.fda.gov ASTM American Society for Testing Materials www.astm.org EAHP European Association of Hospital Pharmacists www.eahponline.org EFPIA European Federation of Pharmaceutical Industries and Associations www.efpia.org ESDA Electrostatic Discharge Association www.eosesd.org ICCCS International Confederation of Contamination Control Societies www.icccs.org IEC International Electrotechnical Commission www.iec.ch APV Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik www.apv-mainz.de IEST Institute of Environmental Sciences and Technology www.iest.org ISO International Organization for Standardization www.iso.ch PDA Parenteral Drug Association www.pda.org ASPEN American Society of Parenteral & Enteral Nutrition www.nutritioncare.org SEMI […]

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To choose cleanroom gloves, nitrile gloves or latex gloves, it is better to understand the cleanroom classification. Cleanrooms are classified according to the number and size of particles permitted per volume of air. Large numbers like “class 100” or “class 1000” refer to Federal Standard 209E (FS 209E), and denote the number of particles of size 0.5 µm or larger permitted per cubic foot of air. The standard also allows interpolation, so it is possible to describe e.g. “class 2000”. The ISO 14644-1 standard uses lower numbers, which specify the decimal logarithm of the number of particles 0.1 µm or […]

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Am I using the right glove for protecting myself and the product? With worldwide cancer rates expected to continue increasing and cytotoxic drugs being at the forefront of our defence for tackling this disease, safety concerns regarding the preparation and handling of antineoplastic agents are likely to grow. The hazardous nature of cytotoxic drugs is widely acknowledged with studies based primarily on animals leading the International Agency for Research on Cancer to classify some chemotherapy drugs as possibly carcinogenic, mutagenic and teratogenic. SHIELD Scientific through its regular seminar programmes and articles in relevant publications has been actively educating users on […]

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All of us in the laboratory have probably encountered personally or from colleagues skin reactions when wearing gloves. Indeed given the substantial increase in glove usage in the laboratory, the fact that the incidence of glove associated reactions has also risen should come as no surprise. To address these concerns, SHIELD Scientific has recently published an article “If hands could speak” in LABORATORY NEWS. The key learning points from “If hands could speak” are as follows: Indentifies the three reactions (Irritant contact dermatitis, allergic contact dermatitis and Natural Rubber Latex allergy) encountered when wearing gloves Distinguishes between glove-associated and non-associated-glove […]

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