Personal Protective Equipment for pharmaceutical and microbiological laboratories Contents Legal foundations 02 Protective gloves 04 Legal foundations Protective overall 08 The main reason behind the comprehensive range of standards and laws in the area of personal protective equipment (PPE) is the safety of the user. PPE is divided up into 3 categories: Protective gown | Protective overshoes 10 Categories and differences for PPE in accordance with the EU directive 89/686/EEC Protective oversleeves | Isolator oversleeves Respirator masks Category I Protection against minimal risks EC Quality Assurance – – EG Type Testing – Marking CE CE CE + Mark No.1 11 12 1 Protective goggles | Spillkit XP 14 Spillkit Z+ | Cytostatic wipe sampling set 15 II III against against deadly hazards medium or serious irreversible damage to health risks Number of the certifiying notified body: http://europa.eu.int The necessary PPE category for each case is determined with the aid of a hazard analysis. For CMR pharmaceuticals, for example, it is the highest category III. PPE user regulations Each country in the EU has its own national laws for the implementation of the EU directive 89/686/EEC. For example, in Germany they are called PPE user regulations and contain the following information. § 1 The law regulates the supply of personal protective equipment (PPE) by the employer as well as stating their use by the employees. § 2 describes the basic requirements which the employer has to adhere to for the acquisition, maintenance and storage of the PPE. § 3 contains information on how to instruct and train the employees in the use of PPE. In Europe all PPE which is brought into circulation has to be tested to the harmonised European EN standards. Tests based on the American ASTM standards are not permissible according to European law. The adherence to the specific standards is intended to provide safety for the user. Values such as permeation times (for chemicals – breakthrough times at a molecular level) can only be compared, if they were all tested to the same standard. 2 Legal foundations Legal foundations within the EU EU - PPE Directive (89/686/EEC) Generals EN standards for specific PPE (e.g. EN 340 for protective equipment, EN 420 for protective gloves) Test standards for application areas (e.g. EN 374 Part 1 for chemical protective gloves) Implementation into national law (Laws regarding the availability of personal protective equipment on the market) PPE - User regulations (e.g. PSA-BV in Germany ) Legal foundations Important European test standards for: Protective clothing (type 3 and 4 only) against chemicals and infectious agents EN 340 - Protective clothing - general requirements EN 14126 - Protective clothing - Performance requirements and tests methods for protective clothing against infective agents EN 14325 - Protective clothing against chemicals - Test methods and performance classification of materials, seams, joins and assemblages EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections EN ISO 6529 - Protective clothing - Protection against chemicals - Determination of resistance of protective clothing materials to permeation by liquids and gases EN ISO 6530 - Protective clothing - Protection against liquid chemicals Test method for resistance of materials to penetration by liquids EN ISO 17491-3 - Protective clothing - Test methods for clothing providing protection against chemicals - Part 3: Determination of resistance to penetration by a jet of liquid (jet test) EN ISO 17491-4 - Protective clothing - Test methods for clothing providing protection against chemicals - Part 4: Determination of resistance to penetration by a spray of liquid (spray test) EN 13921 - Personal protective equipment - Ergonomic principles Voluntary, additional tests which are not compulsory Tests to the American standard ASTM (e.g. ASTM F 1671, ASTM D 697805, etc.) Protective gloves against chemicals and infectious agents EN 420 - Protective gloves - General requirements and test methods EN 374-1 - Protective gloves against chemicals and micro-organisms Part 1: Terminology and performance requirements EN 374-2 - Protective gloves against chemicals and micro-organisms Part 2: Determination of resistance to penetration (Breakthrough due to micro holes) EN 374-3 - Protective gloves against chemicals and micro-organisms Part 3: Determination of resistance to permeation by chemicals (Breakthrough at a molecular level) EN 388 - Protective gloves against mechanical risks Eye protection EN 166 - Personal eye protection – requirements Particle filtering masks EN 149 - Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking 3 4 Protective gloves Protective Gloves The right gloves in the laboratory should not only fit – they should also be easy to change and provide reliable protection against hazardous substances. In accordance with the applicable 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 premium quality protective gloves for many different applications gloves of premium quality – safe and comfortable. Hence you should pay close attention to the quality of the protective equipment. Your safety is at stake. To access further information using your smartphone or pad. Test standards for all of our protective gloves CE-Mark EC-directive declaration of conformity mark based on an EC type test. Type test mark EC type test label based on the specific EC type test certificate. Testing, certification, and control by the named authority, e.g. 0299. EN 374 GLK Protection against chemical hazards Marking for the protection against chemical hazards in compliance to EN 374-3. GMP-compliant manufacturing: Complete documentation For the GMP-compliant manufacturing of e.g. cytotoxic agents sterile protective gloves suitable for cleanroom use are an absolute must. If required Berner International can automatically send you the applicable certificates of sterility for every batch. Protection against chemicals and cytostatics Permeation tests in Europe are always carried out in accordance with the directive 89/686/EEC (PPE) to EN 374-3. This is to guarantee the comparability of the protection functions. However, some products can always be found on the market which have either only been tested to the American standard ASTM F739 or ASTM 6978, or which comply solely with the directive for medical gloves. Protection against viruses and biological agents Penetration tests (Breakthrough through microholes) are tested within the EU in accordance to EN 374-2. Unfortunately the test to EN 374-2 does not include a virus test. For this reason all BERNER protective gloves are always additionally tested to the American standard ASTM F 1671. EN 388 0010 EN 374-2 Protection against mechanical hazards Marking for the protection against mechanical hazards in compliance to EN 388. Protection against bacteriological hazards Marking for the protection against bacteriological hazards to EN 374-2. ASTM F 1671 Voluntary virus test in compliance with ASTM F 1671 (because of the lack of applicable EU-standards). 5 Protective gloves Neoprene – BERNER Manu Prene XP Latexfree Neoprene protective glove – not just for allergy sufferes Material Sterile and non-sterile No detectable allergens Neoprene protective gloves are made from especially high quality polychloroprene and protect the user from CMR substances e.g. cytostatics, various chemicals, biological agents and viruses. Owing to the material composition these gloves are to be particularly recommended for existing latex allergies. Polymer-coated for easier donning and removing Anatomically shaped Tested safety AQL = 1,0 (Water test) Manu Prene XP Z B Perfect for GMP-compliant preparation of cytostatics R R PLUS PLUS Suitable for cleanrooms up to ISO class 5 in accordance to EN ISO 14644-1:1999 To order Size XS (6) S (6½) SM (7) M (7½) ML (8) L (8½) XL (9) Order No.: (non-sterile) 2010 2012 2014 2016 2018 2020 2022 Order No.: (sterile) 2011 2013 2015 2017 2019 2021 2023 For further information using your smartphone or pad. PU = 25 pairs Latex – BERNER Manu L Material Latex protective glove – the tough standard Sterile and non-sterile L stands for „Latex“, a natural product, which is made from the sap of the rubber tree. The protective gloves‘ distinguishing features are their special elasticity, high wearing comfort and extra protective properties for cytostatic substances, many chemicals and biological agents. A special virus protection test provides additional safety. Particularly low in protein: 17 µg/g Powder-free Very low allergenic: 0,5 µg/g Anatomically shaped Tested safety AQL = 1,0 (Water test) Manu L Z B R R PLUS PLUS Optimal for the GMP-compliant manufacturing of cytostatics Suitable for cleanrooms up to ISO class 5 in accordance to EN ISO 14644-1:1999 To order S (6½) SM (7) M (7½) ML (8) L (8½) XL (9) Order No.: (non-sterile) Size 4010 4015 4020 4025 4030 4040 Order No.: (sterile) 4011 4016 4021 4026 4031 4041 PU = 50 pairs 6 To access further information using your smartphone or pad. Protective gloves Nitrile – BERNER Manu N Material Special nitrile mixture Nitrile protective glove at a top price – the marathon glove Sterile and non-sterile No detectable allergens N stands for nitrile, a synthetic copolymer with a special composition. To provide the exceedingly high protective functions of nitrile protective gloves, many years of experience and various permeation tests have been necessary. The Berner protective glove Manu N sets new standards when handling cytostatic substances, biological agents and viruses - and all this at a very attractive price. Particularly resistant to many chemicals Tested safety AQL = 1,5 (Water test) Ideal for GMP compliant production of cytostatic substances Manu N Z B R R PLUS PLUS Suitable for cleanroom use up to ISO class 5 in accordance with EN ISO 14644-1:1999 Permeation Information To order Size XS (6) S (7) M (8) L (9) XL (10) Order No.: (non-sterile) 3010 3015 3020 3025 3030 Order-No.: (sterile) 3011 3016 3021 3026 3031 PU = non-sterile 100 pieces, sterile 50 pairs Tested cytostatics > 480 min. highest protection class 6 of the following substances as per EN 374-3 2003: Carmustine 5-Fluorouracil Doxorubicin Cisplatin Methotrexate Etoposide Cyclophosphamide Mytomycine Thiotepa Daunorubicin Paclitaxel Vincristine Cytarabine Irinotecan Oxaliplatin 8 hour s withou breakt t hrough To access further information using your smartphone or pad. Isolator-glove changing system Z B When handling cytostatic substances and other CMR drugs the German Federal Association for Health and Welfare (BGW) recommends that protective gloves are changed every 30 minutes. The reason for this is the unavoidable breakthrough process at a molecular level (permeation). This means that the movement of a chemical through unbroken protective material. After this process the protective capacity is no longer present. R R PLUS PLUS Keeping to the recommended gloves changing frequency is easily achieved even when working at an isolator Changing gloves safely during use due to multiple sealing system Cost-effective: expensive special gloves are unnecessary Perfect protection: tested and certificated protective gloves Using this innovative glove changing system makes it much easier and safer to keep to the recommended changing times of protective gloves even in an isolator. The complete glove changing system can also be installed at other commercially available isolators and glove boxes. Should you already have a double ring system - our gloves will very likely fit your system too. To access further information on the new glove changing system using your smartphone or pad. 7 The Berner International Bonus Points Type-tested and certified as complex PPE of the category III Active Breath For handling CMR pharmaceuticals (e.g. cytostatic substances) and biological agents Chemical protective coverall type PB[4] for CMR drugs Liquid-tight coating and spray-tight in accordance with EN ISO 17491-4 at the front as well as on the shoulder and leg region Ultrasonically sealed seams Hood and drawn up neck section Zipper with covering Elasticated cuffs at arms and legs Thumb loop for optimum fit Low in particles Comprehensive documentation Certified protective clothing material Breathable material in the back region 8 Coveralls Protective Coverall Active Breath Z B R R PLUS PLUS Z B R R PLUS PLUS Tested breathable personal protection Category III protective coveralls provide optimal protection from hazardous materials such as CMR-drugs (e.g. cytostatics) and biological substances. This tends to be at the expense of breathability and wearing comfort. For this reason cleanroom overalls are more likely to be worn. These offer breathability and protection in the cleanroom, but do not fulfill any certified personal protection functions (in accordance with the PPE directive 89/686/EEC tested PPE must be worn when handling hazardous substances). The new protective overall BERNER Active Breath Z+ B+ is a perfect combination of personal protection and breathability. In the hazardous area (front, shoulder and lower leg region) the new overall is made from certified protective clothing. In contrast, the back part of the overall consists of breathable material and thus guarantees a controlled air exchange to provide optimum comfort while being worn. To order Coverall white Size S M L XL XXL XXXL Chest (cm) 84 – 92 92 – 100 100 – 108 108 – 116 116 – 124 > 124 Height (cm) 164 – 170 170 – 176 176 – 182 182 – 188 188 – 194 > 194 Order No.: (non-sterile) 125610 125615 125620 125625 125630 125635 Order No.: (sterile) 125611 125616 125621 125626 125631 125636 PU = non-sterile 8 pieces, sterile 6 pieces For further details using your smartphone or pad. Protective Overboots Active Breath Z B R R PLUS PLUS Cleanroom compliant protection for your feet For maximum safety Berner International offers the protective overboots as the perfect addition to the new protective coverall. The protective overboots Active Breath Z+ B+ are made from the same tested and certified protective material. They are elasticated at the ankle and leg with additional fixing straps for a comfortable fit around the foot and particle-tight at the overall. A slip-resistant sole makes walking easier and ensures a safe step. High barrier function: see permeation list To order white Size One Order No.: (non-sterile) 125550 Order No.: (sterile) 125551 Ultrasonically sealed seams Elasticated with a fixing strap Slip resistant sole PU = non-sterile 20 pairs, sterile 25 pairs Access additional information using our smartphone or pad. Perfect protection from spills 9 Protective gown Protective gown Z B R R PLUS PLUS Proven partial protection Partial body protection with completely closed front part, extra long cut and drawn up neck section Liquid-impermeable coating in arm and front area Ultrasonically sealed around the arms for high penetration protection Comprehensive permeation tests Breathable at the back With fastening in the upper back and sown straps at the waist Available with knitted or elasticated cuffs Ideal for cleanrooms (as protective gown worn over the cleanroom overall) To order Size S M L* Chest (cm) 76 – 82 82 – 108 108 – 124 Height (cm) 152 – 164 164 – 176 176 – 194 – 65 00 65 50 – 66 00 66 50 67 00 68 00 69 00 67 01 68 01 69 01 Order No.: (non-sterile) Order No.: (sterile) Order No.: (non-sterile) Order No.: (sterile) Elasticated Knitted PU = non-sterile 15 pieces, sterile 10 pieces * The size L of the protective gowns is also fits the European size XL! Protective overshoes Z B R R PLUS PLUS Safe protection for your feet The Berner protective overshoes Z+ B+ with tested anti-slip sole and liquidtight coating offer you maxium protection. The universal shape together with the elasticated ankles guarantee a comfortable fit and make them easy and quick to quickly and easily. Order No. For further information on the protective gowns using your smartphone or pad. 10 For further information on the protective gowns using your smartphone or pad. Size Universal Order No.: (non-sterile) 12 55 01 Order No.: (sterile) 12 55 02 PU = non-sterile 40 pairs, sterile 30 pairs Personal protective equipment (PPE) of the category III Very high barrier function: Comprehensive permeation tests with various cytostatic substances Very high protective function: Highest performance classes for all permeation tests Low in particles Protective sleeves Protective sleeves Z B R R PLUS PLUS Special partial protection The sleeve covers can be used in all situations, where there is no need for complete body protection. The presence of the liquid impermeable coating guarantees the safe protection of your arms at all times. The cone-shaped cut ensures a universal fit and makes them comfortable to wear. The BERNER sleeve covers are available with knitted or elasticated cuffs. Safe protection for your arms Coating is completely impermeable to liquids Comprehensive permeation tests Ultrasonically welded seams for high penetration protection The special cone-shaped cut makes them easy to put on Low in particles Order No. Colour Size Universal Length ca. 52 cm Order No.: (non-sterile) 62 00 Elasticated Order No.: (sterile) Light blue 63 00 Order No.: (non-sterile) Elasticated cuffs 60 00 Knitted Order No.: (sterile) Knitted cuffs Blue 60 01 For further information on protective sleeve covers access using smartphone or pad. VE = non-sterile 50 pairs, sterile 30/40 pairs Isolator-sleeve covers Z B R R PLUS PLUS When working with CMR drugs (e.g. cytostatics) all exposed protective materials are subjected to the potential contamination of a specific substance. The sleeve covers which are permanently attached to the isolator also lie within the exposed area. However, here it is difficult to keep to specific changing intervals. For this reason BERNER offers you a patented sleeve cover system, which is pulled over the existing ones. The sleeve cover system consists of tested and certified PPE and has to be changed daily. In this way permeation through the fixed isolator sleeves can be avoided. Order No. white Size Order No.: (sterile) PU = 15 pairs Universal 6451 Further information on the isolator system using your smartphone or pad. Isolator-sleeve covers for cytostatic preparation 11 Respirator masks & protective goggles 12 Respirator masks FFP-3D-Respirator mask Your protection against particles and aerosols with the highest effiency Respiratory masks by BERNER are specially suited for handling CMR pharmaceutical drugs (e.g. cystostatics, virostatics, etc.), biological agents and viruses. Our masks provide the perfect protection from particles and aerosols. Minimum exhaling resistance and the integrated exhalation valve ensure the highest wearing comfort. Type-tested and certificated in accordance with the EU-directive 89/686/EEC (personal protective equipment). Classification* Efficiency FFP-1 > 70 % FFP-2 > 92 % FFP-3 > 98 % Category III personal protective equipment (PPE) in accordance with EU-directive 89/686/EEC To order Particle filtrating FFP-3 half mask in accordance to EN 149 Type Best protection: Retaining capacity of at least 99 % Order No. (non-sterile) Against dust, aerosols and aerosol mist (not suitable for gases) Order No. (sterile) Extended working hours: Valve reduces the exhalation resistance PU = 1 piece; sterile = 4 pieces Suitable for CMR drugs,biological agents and viruses Respirator mask A mask with a filtration efficiency of 70 %, allows 30 % of the particles to pass through the mask. When working with CMR drugs BERNER recommends the use of FFP-3 masks only. (*in accordance to EN 149) FFP-3D FFP-3D FFP-3D Preformed Preformed Folding mask* 121287 121262 121285 - - 121286 * latex-free Access additional information about the respirator masks using your smartphone or pad. The pre-shaped FFP-3 respiratory mask with integrated valve and firm mask body made by UVEX Safety. The newly-developed, optimised design of this moulded FFP-3 mask preformed mask with a soft sealing lip makes it very comfortable to wear while at the same time optimising the protection functions. The FFP-3 respirator protection mask by Moldex with an integrated valve and firm mask body. The sealing lip and the flexible straps provide the highest comfort. The mask has a fixed shape for easy donning and removal, and ensures a perfect fit. The FFP-3 respirator folding mask with integrated exhalation valve made by UVEX Safety. Due to the special design of this FFP-3 mask the perfect fit (and therefore the protective function) can be checked easily. The folding feature of this latex-free mask is very practical and space saving to store. 13 Safety goggles The safety goggles The goggles for safety and anti-fog vision – for handling chemicals and CMR drugs The fully enclosed safety goggles made by UVEX Safety guarantees optimum protection against mechanical risks, liquids and particles. The flexible, soft shape and the adjustable straps offer the highest wearing comfort, even when worn over ordinary glasses. This is made possible due to the special shape and the selection of top quality materials,. Because especially full vision goggles should not lead to pressure marks when worn with spectacles. A well-designed ventilation system and the specal anti-fog coating ensures clear vision at all times. With a nti-fo coatin g g To order Size Order No. To access further information on the safety goggles using your smartphone oder pad. PU = 1 piece Type: Protection against mechanical risks, liquids and particles Large volume full vision goggles For handling chemicals, cytostatics and biological agents Side protection Special: Increased mechanical rigidity (S) Anti-mist – with anti-fog coating Optical class 1 Circumferential, indirect ventilation system Universal fit Wide field of vision – transparent sides Colour: transparent Opaque-coloured upper part of the body of the goggles – to prevent light reflecting Tested safety: Flexible, soft – wearable over worn spectacles Personal protective equipment (PPE category II) Headband easily and comfortably adjustable Type-tested and certificated (based on EN 166) Suitable for use in combination with respiratory halfmasks Certification body: CE 0196 - DIN CERTCO SpillKit XP Z Extra Protection PLUS Certified emergency and cleaning set for cytostatics With the aid of the BERNER Spillkit XP you have all the necessary tools at hand to eliminate different types of cytostatic contaminations in an easy and safe way. The Spillkit XP has been type-tested by an external certification authority and is recommended by the DGOP and ESOP. ur free Order yo copy! Type-tested and certified Category III personal protective equipment (PPE) Optimized equipment for all types of cytostatic spills Contains an approved protective coverall and protective overboots (Kits come in different sizes) Also available as latex-free version Recommended by the DGOP and ESOP To order Size Order No. M L XXL 4104 4112 4115 4134 4135 Latex-free version Order No. 14 4124 Suitable for cleanrooms - Spillkit instruction poster For further information on the Spillkit XP using your smartphone or pad. one 12 14 05 More from Berner International NEU! Ab Septem ber Standard emergency and cleaning kit for cytostatics 12 Substan zen Our proven BERNER SpillKit Z+ contains cytostatic protective equipment, several tools, an accident report form and much more – so that you aareuswelleiner P prepared in case of an accident involving CMR drugs (e.g. cytostatics). robe SpillKit Z PLUS Tested and certified PPE of the highest category III Protective gown included Contains all the required tools e.g. ChemoSorb-pad, Isysoft cleaning wipes, etc. Comprehensive documentation To order a en-Set Cytostatic wipe sampling set For further information on the Spillkit Z+ per smartphone or pad. Size One Order No. 4004 Spillkits for other applications available on request PU = 1 piece PharmaMonitor Easy and fast When handling CMR drugs (e.g. cytostatics) unintentional contaminations can easily occur through contaminated gloves, vials, protective clothing, shoes, wheels from transport trolleys, etc. Accidents or disruptions to the air flow of safety cabinets can lead to the release of cytostatic substances. As part of the MEWIP-study (Monitoring-Effect-Study of wipe samples in pharmacies in Germany) it was found that, for example, in 61 % of all samples cytostatics were detected. uellen aufdecken nell! In cooperation with the German Institute for Energy and Environmental Technology e.V. (IUTA) Berner International has developed a wipe sample set with the aid of which contaminations can be verified quickly and safely. With regular monitoring any weak points during the preparation, handling and cleaning can be easily uncovered and eliminated. Wipe sampling carried out by our own trained personnel Detailed results on individual substances 5-Fluorouacil Oxaliplatin Clomiphen Cyclosphosphamide Total platinum Cytrabine Ifosamide Mitomycine Flutamide Validation of cleaning processes Gemcitabin 6-Mercaptopurine Tamoxifen Uncovering of contamination sources Etopside Acemetacine Thalidomide Methotreaxte Azathioprine Doxorubicine Control and optimisation of work processes Paclitaxel Busulfane Epirubicine Proof of best work procedure for your customers Docetaxel Capecitabine Irinotecan Cost-effective analysis tool Cisplatine Carmustine Topotecan Can be carried out by own staff Carboplatin Chlorambucil Analysis of numerous single substances or substance groups with cost-effective multi-methods Fast and detailed report on findings Improved protection for your employees Access further information on wipe samples sets with your smartphone or pad. Video Example of wipe sampling 15 Safety systems & further products from Berner International Berner International has been involved in occupational and product safety for pharmaceutical and biotechnological applications since 1982. Cytostatic safety cabinets Preparation mats Microbiological safety cabinets Cleaning cloths and wipes Cytotoxic isolators / Glove box Withdrawal cannulae / spikes Waste sealing units UV light protection bags Technical services Tubular foil and much more.. Please contact us for additional information or visit our homepage - www.berner-international.eu Berner International GmbH Mühlenkamp 6 D-25337 Elmshorn Germany [email protected] www.berner-international.eu Hotline +49 (0) 41 21/43 560 Telefax +49 (0) 4121/43 56 - 20 GB-12 0990-A / 02/2014 We are experts in the provision of safety systems for the safe preparation and application of cytotoxic substances as well as for handling biological agents.
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