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Personal protective equipment and consumables
Personal protective equipment and consumables
This document provides a detailed overview of personal protective equipment (PPE) and consumables, focusing on safety standards, legal foundations, and categorization according to EU regulations. It emphasizes the importance of adhering to specific standards to ensure user safety and outlines the categorization of PPE based on risk levels.
PPE is categorized into three categories under EU Regulation 2016/425, which replaced the previous directive 89/686/EEC. The categories are:
- Category I: Protection against minimal risks.
- Category II: Protection against medium risks.
- Category III: Protection against deadly hazards or serious irreversible damage to health.
The German PPE user regulations (PSA-BV) align with EU Regulation 2016/425, detailing employer responsibilities for providing and maintaining PPE, as well as training employees in its use. All PPE in Europe must comply with harmonized European EN standards.
The document outlines key legal provisions and standards, including:
- EU Regulation 2016/425
- General EN standards for specific PPE (e.g., EN 340 for protective clothing)
- Test standards for specific applications (e.g., EN 374 for chemical protective gloves)
- Implementation into national law
- PPE user regulations (e.g., PSA-BV in Germany)
Protective gloves are essential for handling hazardous substances. The document emphasizes the importance of selecting gloves that fit well, are easy to change, and provide reliable protection. It discusses the transition from EN 374-3 to EN 16523-1 and EN 16523-2 standards for permeation tests and highlights the importance of testing gloves against both European and American standards for comprehensive protection.
The document provides detailed information on various glove materials, including:
- Latex: Known for elasticity and chemical resistance but can cause allergies.
- Polyisoprene: Similar to latex but free of allergenic substances.
- Vinyl: Inexpensive but offers limited protection.
- Polychloroprene (Neoprene): Latex-free and offers good protection against solvents.
- Nitrile: Offers good resistance to oils and chemicals, depending on the composition.
Protective gloves must meet EN 420 requirements and undergo penetration and permeation testing according to EN 374 standards. The document explains the testing process and the significance of AQL values in determining glove quality.
Protective gloves are categorized based on their resistance to chemicals. Type A gloves resist at least six chemicals for 30 minutes, Type B resist three, and Type C resist one for 10 minutes. Gloves are marked with an Erlenmeyer flask symbol indicating their type. Mechanical risks are assessed according to EN 388, testing for abrasion, cutting, tearing, and puncture resistance. Category III personal protective equipment (PPE) gloves require certification by a Notified Body and adherence to quality management systems.
Various single-use gloves are available, including nitrile, neoprene, and latex options. Nitrile gloves, such as the Manu N, offer high chemical resistance and are suitable for handling cytostatics and biological agents. Neoprene gloves, like Manu Prene XP, are recommended for those with latex allergies. Latex gloves, such as Manu L, provide elasticity and comfort. Each glove type is tested for permeation and certified for safety, including viral protection and compliance with medical standards.
Reusable gloves, such as Ultranitril 480 and 492, offer long-lasting chemical protection. These gloves are made from nitrile and are designed for durability and comfort. Other options include Stansolv AK 22 381, which combines nitrile with cotton for thermal insulation, and Trionic 517, suitable for cleanrooms. Kronit-Proof 395 provides cut resistance and chemical protection, while Butoflex 651 offers resistance to a wide range of chemicals.
For handling hazardous substances, gloves should be changed every 30 minutes to prevent permeation. The isolator-glove changing system facilitates safe glove changes during operations. Understanding the difference between penetration (through micro-holes) and permeation (at a molecular level) is crucial for maintaining safety standards.
The document outlines various protective gloves and clothing, focusing on their specifications and certifications. The gloves are categorized as personal protective equipment (PPE) of the highest category III, offering protection against chemical risks according to EN 374-3-2003 and ASTM F 739 standards. They feature the highest cut resistance class 5 and electrostatic properties. Materials used include nitrile/cotton and butyl rubber, with specific designs like anatomical shape and rolled cuff edge.
The document discusses degradation testing of protective gloves in accordance with EN 374-4, which assesses the material's puncture resistance after chemical exposure. It emphasizes the importance of testing reusable gloves for degradation to ensure continued protection.
Various types of protective coveralls are described, including Tyvek® Classic Plus, Tychem® C, and Tychem® F, each offering different levels of protection against chemicals and biological agents. The document highlights the importance of selecting appropriate protective clothing based on risk assessments and compliance with PPE regulations 2016/425.
The document advises on the selection of protective clothing for cleanrooms, emphasizing the need for certified PPE to ensure both personal and product protection. It also introduces a testing method for particle emissions from protective clothing in cleanrooms, ensuring optimal safety and compliance with ISO 14644-1 and GMP guidelines.
The document includes order numbers for various sizes and types of gloves and coveralls, along with their specifications such as material, length, and thickness. It also provides guidelines for cleanroom classifications and the necessary protective measures for handling hazardous substances.
The document discusses the requirements and advancements in protective clothing suitable for cleanrooms, focusing on particle emissions and compliance with ISO and GMP standards.
Protective clothing must meet cleanroom and product protection standards. New production methods allow for certified protective clothing suitable for cleanrooms, addressing past issues of particle release.
ISO classifications range from Class 1 to Class 9, detailing air purity levels for cleanrooms. GMP classes A to D specify limits for microbiological contamination and particle emissions.
1. Helmke-Drum: Tests particle emissions by rotating textiles in a drum.
2. Suction Method: Measures particles released through air-permeable materials.
3. Body-Box: Assesses particle emissions during wear in a controlled environment.
Various protective clothing options are available, including:
- Protective Overboots: Active Breath and Tyvek® Isoclean® for ISO-class 4 and 5.
- Safety Boots S5: For pandemic use, offering puncture resistance.
- Protective Gowns and Aprons: Tyvek® Classic Plus and Tychem® F for chemical and biological protection.
- Protective Oversleeves: Tychem® C and Tyvek® IsoClean for arm protection.
Respiratory masks are categorized into particle-filtrating half masks (FFP masks) and full-face masks with replaceable filters. Certified masks comply with EN 149 standards for FFP-2 and FFP-3 levels, suitable for laboratory use against particles and aerosols.
Certified protective clothing and equipment are essential for cleanroom operations, ensuring both personal and product safety. The document provides detailed ordering information for various protective gear.
FFP masks are classified according to their filtration rates as per EN 149 standards. FFP-1 masks have a filtration rate of over 78%, FFP-2 over 92%, and FFP-3 over 98%. These masks are designed to protect against harmful dusts, but their effectiveness against nanoparticles is not covered by the standard test procedures.
Nanoparticles, due to their small size, can penetrate the respiratory system and cause damage. A special test method developed with the University of Milan showed that BLS masks can retain more than 97% of nanoparticles, offering protection beyond EN 149 requirements.
The document details various respiratory masks, including the BLS 860 and BLS Zero 31, which provide protection against nanoparticles up to 0.001 μm. The FFP-3 masks from Uvex and Moldex offer high comfort and protection against particles, aerosols, and viruses, suitable for handling hazardous substances.
Safety goggles are essential in laboratories and must comply with EU directives. Uvex offers autoclavable safety goggles with anti-fog coatings, suitable for cleanrooms and compatible with other PPE. Gas-tight goggles like the Uvex Ultravision and 3M Fahrenheit SA are designed for handling gases and airborne viruses.
With increasing global mobility, infectious diseases spread rapidly. Pandemic and anti-infection sets are crucial for protecting healthcare workers during outbreaks of diseases like Ebola and MERS-CoV.
Berner International provides comprehensive pandemic protection sets designed for healthcare workers operating in infectious areas. These sets comply with the German Robert-Koch-Institute (RKI) recommendations and include personal protective equipment (PPE) such as chemical protective coveralls, safety boots, respiratory masks, safety goggles, and gloves. The sets are available in different configurations to meet specific needs, with options for limited or extended exposure times.
The pandemic protection sets are categorized into Type 1 and Type 2, each designed for different exposure durations and protection levels. Type 1 sets are suitable for up to 8 hours of exposure and include items like a liquid-tight chemical protective coverall, safety boots, and a particle filtering mask. Type 2 sets are for extended exposure and include a full face mask with a respiratory filter for comprehensive protection and decontamination.
Berner International offers a range of consumables for laboratory use, including withdrawal cannulas, swabs, and spill kits. These products are designed to enhance safety and efficiency in handling hazardous substances. The UltraSpike II and MicroSpike are specialized cannulas for safe and complete vial emptying, while the SpillKit XP provides tools for managing cytostatic spills.
The SpillKit XP and SpillKit XP Duo are emergency sets for handling cytostatic spills, containing PPE and cleaning tools. These kits are recommended by professional organizations and are available in latex-free versions. Additionally, Berner offers a binding agent for formaldehyde spills and a wipe sampling set for detecting contamination from CMR drugs.
Berner International's products are designed to meet high safety standards, providing essential protection and tools for healthcare and laboratory environments. Their offerings include customizable PPE sets and consumables that address the challenges of infectious disease management and hazardous material handling.
Catalog excerpts
PRODUCT BROCHURE Personal protective equipment and consumables
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Legal foundations Eu directives The reason behind the comprehensive range of standards and laws on the subject of personal protective equipment (PPE) is the safety of the user. PPE is divided into 3 categories: CATEGORISATION AND DIFFFERENCES OF PPE IN ACCORDANCE WITH THE EU REGULATION 2016/425 (PREVIOUSLY 89/686/EEC – A TRANSITIONAL PERIOD APPLIES UNTIL 21 APRIL 2018) • EN ISO 13688 ‒ Protective clothing - general requirements • EN 14325 ‒ Protective clothing against chemicals - Test methods and performance classification of materials, seams, joins and assemblages against minimal risks against...
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Contents Personal protective equipment and disposables for pharmaceutical, chemical and biological hazards Protective gloves Safety goggles Emergency sets Protective clothing Anti-infection & Pandemic sets Wipe sampling sets Respiratory masks
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BERNER INTERNATIONAL Protective gloves Protective gloves The right glove should not just fit – it should also be easy to change and above all, provide reliable protection against hazardous substances. In accordance with the relevant regulations in the EU, the employer is required to provide his employees with suitable protective gloves of the correct category when handling dangerous materials. Berner International offers certified gloves of premium quality - safe and comfortable. Therefore you should pay attention to the quality of your personal protective equipment. Your safety is at stake....
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BERNER INTERNATIONAL Protective gloves COMPLETE DOCUMENTATION For the GMP-compliant manufacturing of e.g. cytotoxic drugs sterile single use protective gloves which are suitable for cleanroom use are an absolute must. On request Berner International can automatically send you the appropriate sterility certificates for every batch. PROTECTION AGAINST CHEMICALS AND CMR DRUGS Permeation tests were carried out in Europe in line with the directive 89/686 / EEC (PPE) for many years in accordance to EN 374-3. In 2015, the EN 374-3 standard was replaced by standards EN 16523-1 and EN 16523-2. A new version...
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BERNER INTERNATIONAL Protective gloves Expert knowledge - glove materials MATERIALS FOR SINGLE USE GLOVES LATEX Latex has been the material for disposable gloves, for medical as well as protective gloves. In the fifteenth century Spanish conquerer brought natural latex from South America to Europe. For a long time no one saw the great potential in the juice of the rubber tree Hevea brasiliensis, until Charles Goodyear in 1839 developed vulcanization by chance. Since 1890 examination gloves made of latex have been used in medicine. The material is elastic, comfortable to wear and resistant to...
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BERNER INTERNATIONAL Protective gloves Further materials Polychloroprene is a high-quality synthetic rubber, which was manufactured by Arnold Collins for the first time in an economical emulsion process. The material, also known under the brand name neoprene, is used for a variety of applications. In addition to protective gloves and the basis for adhesives, the vulcanized variety has become known as a diving and swimming suit. Polyisoprene is a relatively new and currently very expensive material. The latex material is almost molecularly accurate and therefore has the same good stretching and...
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BERNER INTERNATIONAL Protective gloves Fig. 3: An example of a test cell How do medical gloves differ from protective gloves? Medical gloves are primarily used for hygiene and to avoid infections during the doctor-patient contact. This type of disposable gloves are tested according to EN standard 455 (single use medical gloves). These include a leak test, an examination of the physical properties, a biological evaluation of the gloves (protein content, endotoxin content, ...) and minimum requirements. Chemical protection gloves, on the other hand, are intended to protect the user from hazardous...
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BERNER INTERNATIONAL Protective gloves Penetration testing of chemical protective gloves Mechanical risks Chemical protective gloves must continue to comply with the EN 374 standard (protective gloves against chemicals and micro-organisms). In the penetration test in Part 2, the glove is examined by filling with air or water on micro-holes. Furthermore, protective gloves according to EN 388 (protective gloves against mechanical risks) are still tested for abrasion resistance, cutting strength, tear strength and puncture force. Only after all these examinations have been successfully passed, the...
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BERNER INTERNATIONAL Single use protective gloves Certified safety + AQL = 1.5 (water test) + Ideal for e.g. the GMP-compliant production of cytostatics + Suitable for cleanrooms up to ISO class 5 to EN ISO 14644-1:1999 + Sterile poly/poly bag packaging + Viral protection in accordance to ASTM F 1671 Dermagrip Ultra LT*Protective glove with innovative SafeDon-dispensing system Short nitrile protective glove for working in non-sterile areas (e.g. preparatory work in the cytostatic laboratory, biology laboratory, oncology ward, veterinary practice, etc.). With the new SafeDon dispenser system contaminations...
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Material + 5 year shelf life + Sterile and non-sterile + No detectable allergens + Polymer-coating for easy donning and removal + Anatomical shape + Length: 295 mm + Special stainless steel dispenser system available Material + 5 year shelf life + Sterile and non-sterile + Powder-free + Low in protein: 17 pg/g + Very low allergenic: 0.5pg/g + Anatomical shape + Length: 295 mm + High material thickness + Special stainless steel dispenser system available BERNER INTERNATIONAL Single use protective gloves Neoprene protective gloves made from especially high quality polychloroprene and protect the...
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BERNER INTERNATIONAL Single use protective gloves Material + Sterile + Powder-free + Low in protein: 12 pg/g + Very low allergenic: 0.3 pg/g + Anatomical shape + Length: 290 mm Material + Sterile + Powder-free + Low in protein: 12 pg/g + Very low allergenic: 0.3 pg/g + Anatomical shape + Length: 290 mm Profeel NR Latex glove - low material thickness with good protection Chemical glove with optimised fit for long, fatigue-free working. Due to the low wall thickness the glove also offers good tactile sensitity and is suitable for double-gloving. The inner coating makes it easier to change the gloves, the...
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