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Life Sciences Protection

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BioClean coveralls and drop-down garment

Production and Manufacturing

Our protection solutions eliminate cross contamination during the manufacturing of critical products including vaccines, tablets and cancer drugs within a cleanroom environment. ​
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Frequently Asked Questions

What are the certifications of our cleanroom gloves?

All our CE-marked cleanroom gloves are certified to comply with the requirements of the Personal Protective Equipment Regulation (PPER), (EU) 2016/425. Under the terms of the regulation our gloves are classed as Category III PPE. By CE marking our we claim that they satisfy the essential safety requirements of Regulation (EU) 2016/425 by the application of the following standards: EN 420:2003 +A1: 2009: Protective gloves – general requirements; EN 374-1: 2016: Protective gloves against dangerous chemicals and microorganisms – Part 1 Terminology and performance requirements for chemical risks; EN 374-2: 2015: Protective gloves against dangerous chemicals and microorganisms – Part 2 Determination of resistance to penetration; EN 374-4: 2013: Protective gloves against chemicals and microorganisms – Part 4 Determination of resistance to degradation by chemicals; EN 374-5: 2016: Protective gloves against dangerous chemicals and microorganisms – Part 5 Terminology and performance requirements for micro-organisms risks.

BioClean RABS & Gloves are 100% inspected, how?

Our manufacturing process has five separate product inspections throughout. Each Nitrile RABS/Isolator glove/mitten is visually inspected 100% for holes, along with water and air pressure testing. This is achieved by the gauntlet being filled with air to a specified pressure before being submerged underwater for three minutes. The water is checked for any bubbles identifying whether the product has a pinhole leak. This 100% inspection guarantees delivery of a glove or mitten free from holes, and is more rigorous than the AQL approach for surgical gloves which is based on a statistical sampling plan.

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RABS and Isolator Gloves FAQs

Are my gloves suitable for use with Cytotoxic (Chemotherapy) drugs?

We have a comprehensive range of gloves suitable for use in this highly specialized area. Gloves tested against ASTM D6978-05 for a wide range of Cytotoxic drugs, recording excellent barrier performance under the ASTM defined permeation rates of 0.01µg/cm2/min, a level 100 times more stringent than that of EN 16523-1:2015. We will be pleased to supply further information on request.

Which gloves should I use if I need ESD properties?

Nitrile, Neoprene/Polychloroprene and Vinyl gloves are the best to choose when looking for a glove with good ESD properties. The differences between anti-static and ESD are - ESD properties means the characteristics of a material which determine the way it performs when exposed to static electricity. Anti-staticis the property of a material which either prevents the build-up of static electricity or reduces its effects.

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