DuPont Personal Protection Chemical Protective Clothing Solutions
2 Disclaimer This information is based upon technical data that DuPont believes to be reliable. It is subject to revision as additional knowledge and experience becomes available. DuPont does not guarantee results and assumes no obligation or liability in connection with this information. It is the user s responsibility to determine the level of toxicity and the proper personal protective equipment needed. This information is intended for use by persons having the technical expertise to undertake evaluation under their own specific end-use conditions, at their own discretion and risk. Anyone intending to use this information should first check that the garment selected is suitable for the intended use. The end-user should discontinue use of garment if fabric becomes torn, worn or punctured, to avoid potential chemical exposure. Since conditions of use are beyond our control, we make no warranties, expressed or implied, including but not limited to warranties of merchantability or fitness for a particular purpose and assume no liability in connection with any use of this information. This information is not intended as a licence to operate under or a recommendation to infringe any patent or technical information of DuPont or other persons covering any material or its use.
WHAT DO YOU NEED TO PROTECT? 3 PEOPLE AGAINST HEALTH RISKS Barrier: INSIDE to outside Barrier: OUTSIDE to inside PRODUCT AGAINST PEOPLE
SOURCES OF CONTAMINANTS 4 Work with Tools/equipment 30% Gases and chemicals 18% People 80% People 30% Air 2% Machinery 20% Air 5% Materials 15% Source: DuPont
FUNCTIONS OF CLEANROOM CLOTHING 5 Protection of PRODUCT and CLEANROOM against contamination by people Protection of PEOPLE against solid or liquid hazardous substances and biological hazards Shall offer good electrostatic charge dissipation Shall not generate contamination Shall not cause any strains to the wearer
CLEANROOM CLOTHING POTENTIAL SOURCE OF CONTAMINATION 6 The material surface shedding Residues remaining from the cleaning or decontamination treatment Particle that penetrate the cleanroom clothing through the fabric, openings or, seams fibre release if low abrasion resistance of the clothing fabric.
RECOMMENDATIONS FOR CLEANROOM CLOTHING ACCORDING TO GMP CHAPTER 2: PERSONNEL 7 ANNEX 1: Manufacture of Sterile Medicinal Products EXTRACT VOL. 4: Guidelines for good manufacturing practices for medicinal products for human and veterinary use
LEGISLATIVE CLOTHING REQUIREMENTS 8 Directive 89/391/EEC Introduction of measures to encourage improvements in safety and health of workers at work Directive 89/656/EEC Minimum health and safety requirements for the use by workers of personal protective equipment at the workplace PEOPLE PROTECTION GMP and IEST provide guidance on garment usage to maintain product quality and cleanroom environment. No legislative requirements with regard to clothing in place. PRODUCT PROTECTION
9 CLOTHING PERFORMANCE Protection against Particles Biological agents Chemicals REQUIREMENTS Low particle generation Garment design shall allow tightness of clothing and minimise risk of particle accumulation on the garment Comfort Durability Fit Static discharge Suitable for sterilisation Clothing performance = Fabric plus Design plus Sizing plus Manufacturing quality plus PPE compatibility DEFINITION
WHAT DO YOU NEED TO PROTECT? 10 PEOPLE AGAINST HEALTH RISKS Barrier: OUTSIDE to inside -Which chemicals are we handling? = chemical barrier - How are the working conditions? = physical properties - Which material gives me the necessary chemical barrier & the necessary fabric performances? = choosing the right fabric - How should the garment look like? = garment design
11 Against what chemical do you need protection? Asbestos, Dioxine Body fluids Hazardous gases Oils and lubricants Inorganic, organic chemicals Dyes, Colours, inks Disinfectants Nutraceuticals (Vitamins, etc.) Dirt. Others
Applications for Chemical Protective Clothing Agrochemical handling Asbestos Automotive industry Bio engineering Chemical industry Civil protection Cleanroom Decommissioning of production plants Decontamination of contaminated land Disease and disaster management Disposal of hazardous materials Emergency response services, spill clean-up and accident interventions Electronics Fire brigades Food processing Industrial cleaning and maintenance Medical applications and exposure to biological hazards Military applications Nuclear industry Oil handling, oil tanker cleaning Pharmaceutical industry Tank cleaning, inspection and maintenance 12
13 Categories of personal protective equipment European Directive 89/686 EEC Category III Risk High Example Chemical protection CE-Marked CE XXXX Category II Risk Medium Example Gloves High visibility clothing CE-Marked CE XXXX Category I Risk Minor Example Sun glasses (PPE) Foul weather clothing CE-Marked CE
CHEMICAL PROTECTION Type 1-6 14 OVERVIEW Type indication doesn t tell you the performances of the garment. It only tells that it meets the minimum requirements of type certification.
15 Chemical protective clothing - Performance requirements for CE-Marking Fabric + Whole suit
16 Chemical protective clothing Fabric requirements for CE-marking according to EN 14325 Type1 Type2 Type3 Type4 Type5 Type6 Abrasion resistance Burst resistance Flex cracking resistance Flex cracking resistance at 30 C Trapezoidal tear strength Tensile strength Puncture resistance Resistance to permeation of liquids Resistance to ignition Repellency to liquids Resistance to penetration by liquids Resistance to flame = required, = optionel, = not required, if clothing intended for use under respective conditions
CHEMICAL PROTECTION Penetration Permeation Physical process Chemical process 17 Barrier properties Penetration Permeation What s the difference between penetration & permeation? Penetration is a process whereby liquid, gaseous or solid substances penetrate a fabric by passing through the pores or holes. Process where on a molecular level molecules of a hazard are passing through a fabric. Absorption of molecules of liquids onto contact surface, Diffusion of the sorbed molecules through material, Desorption from the opposite surface PEOPLE PROTECTION
CHEMICAL PROTECTION Repellency by liquids EN 368/ISO 6530 Rates the repellency of liquids of a fabric by a specific liquid chemical Unit: % of repellency Three performance classes Resistance to penetration by liquids EN 368/ISO 6530 Rates the resistance of a fabric to penetration by a specific liquid chemical Unit: % of penetration Three performance classes Predefined chemical panel 18 Barrier properties Penetration and repellency PEOPLE PROTECTION
How is penetration by liquids measured? 19 Resistance to penetration by liquids according to EN 6530/EN 368 It gives an indication of the penetration of the fabric when exposed to a specific chemical. Unit: %, repellency penetration Exposure time: 1 minute Amount of chemical: 10 ml Supportive gutter Test material 45 inclination Syringe Absorptive material to take up penetrated liquid Beaker to collect repelled liquid
20 How is permeation measured? Tested according to EN ISO 6529/EN 369/EN 374-3 Rates the resistance of a fabric to permeation by a specific liquid chemical. Fill Level Testmaterial Unit breakthrough time: min Hazard Permeation rate = Mass/Area Time µg/cm² min = breakthrough of mass calculated on contact area and contact time To Analyzer
CHEMICAL PROTECTION 21 Barrier properties Rates the resistance of a fabric to permeation by a specific liquid or gaseous chemical Unit: Breakthrough time in minutes* Six performance classes Permeation EN 374-3 EN ISO 6259 PEOPLE PROTECTION * Normalised breakthrough times at 1.0 µg/cm 2.min according to EN ISO 6529
Typical permeation cell results 22 Permeation rate (µg/cm 2.min ) CE-Marking level 1.0 Steady state 0,1 Actual breakthrough time (min)
Attention 23 All permeation data and Gutter test results are supposed to compare materials Information on safety and safe wear time are not given by these data (fabric data only!) The DuPont Techline gives written recommendations for the chemicals you are using in your daily work!
CHEMICAL PROTECTION 24 Mechanical properties Abrasive paper pressed down by a 900 gr weight covering the whole surface Unit: Cycles Low minimum requirement Six performance classes Abrasion resistance EN 530-2 PEOPLE PROTECTION Endpoint by pressure pot when possible or visual
CHEMICAL PROTECTION 25 Mechanical properties Force required to pull the material apart Simulates tearing of protective clothing material and indicates force required to tear Low minimum requirements Unit: Newton (force) Test with Tyvek Tensile strength EN ISO 13934-1 PEOPLE PROTECTION Six performance classes
WHAT DO YOU NEED TO PROTECT? 26 Barrier: INSIDE to outside PRODUCT AGAINST PEOPLE
TYVEK : particle barrier efficiency 27 Inside Outside Parameter Test conditions Unit Average result across 3 or 4 Tyvek samples Particle migration (Martindale) 500 cycles 9 kpa Fibres/ cm 2 < 50** Barrier efficiency against airborne particles* (25mg/m 3 ) >0.3 µm/ 15 min/ > 0.3 µm/ 60 min/ % % > 99.2 > 99.8 Attention: This data is only applicable to standard Tyvek - not cleaned and/or sterilised. Climatic conditions : 23 ± 1 C, 50 ± 5 % RH. Source: ITV Test report Nr. E-0068-TT-07
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TYVEK : particle barrier efficiency Body Box results Taped seams 29 Movement of person Particle size Tyvek Classic Tyvek Classic Plus Tyvek Industry Unit: P/min Arm movement > 0.3µm > 5.0µm 183 11 76 4 134 9 Stand still > 0.3µm 83 34 89 > 5.0µm 2 0 4 Walking > 0.3µm 390 104 170 > 5.0µm 32 6 13 Stand still > 0.3µm 73 55 137 > 5.0µm 2 0 7 Knee bends > 0.3µm 2961 405 1137 > 5.0µm 159 21 77 Stand still > 0.3µm 117 15 110 > 5.0µm 6 0 6 Attention: This data is only applicable to standard Tyvek - not cleaned and/or sterilised. Source: ITV Test report Nr. E-0068-TT-07
TYVEK : cleanliness 30 Parameter Test condition Unit Tyvek Classic range across three samples Helmke Drum Test IEST-RP-CC003.3 P > 0.3µm P > 0.5µm P/min 4760 16 400 4370 14 800 P > 5.0µm 870 2 100 Class II-III Attention: This data is only applicable to standard Tyvek - not cleaned and/or sterilised. Climatic conditions : 23 ± 1 C, 50 ± 5 % RH, Source: ITV Test report Nr. E-0068-TT-07
PRODUCT RECOMMENDATION BY CLEANROOM CLASS PRODUCT PROTECTION PEOPLE PROTECTION 31
32 Comparing the different clothing fabrics
CLOTHING FABRICS 33 FABRIC CATEGORY WOVEN MATERIALS EXAMPLES Polyester Polyamid e.g. reusable cleanroom or lab clothing NON-WOVENS COATED OR LAMINATED FILM-LAMINATES PP, SMS, SMMS Microporous film TYVEK Coated PP TYCHEM C, TYCHEM F TYCHEM TK Typ 6,5, 4 coveralls Typ 4, 3 coveralls OTHER HIGH-END MATERIALS PVC Neopren Viton Typ 1
CLOTHING FABRICS COMPARISON 34 50 x 50 x TYVEK structure Woven structure POLYMER FIBER BONDED WOVEN
35 Unique Barriere Material only from DuPont Manufactured from HDPE ultrafine endless fibers with unique bonding technology ( Flash Spinning ) Ideal Combination of Barrier, Durability and Comfort
TYVEK summary Protection Outstanding barrier against particles >1µm. High resistance against low-pressurised water-based liquid chemical splashes Repellent due to ultra-smooth surface Durability Extremely tough, tear and abrasion resistant Coveralls maintain protection levels throughout usage in arduous conditions Comfort Permeable to air and water vapour breathable extremely light (41 g/sqm), soft and flexible Antistatic Electrostatic charge build-up is prevented (when coveralls are correctly earthed) Ultra-low risk of process contamination Low-linting Does not contain fillers, binders, silicons, 100% HDPE Suitable for clean-rooms 36
MICROPOROUS FILM 37 Calcium-Carbonate- Particles Film (PE) thickness : 50-100 µm thickness after stretching : 6-20 µm
CLOTHING FABRICS COMPARISON 38 TYVEK MICROPOROUS FILM BARRIER LAYER BARRIER LAYER 200 x 200 x BARRIER LAYER BARRIER LAYER High, homogene barrier 0,1 mm Very thin barrier 0,02 mm
CLOTHING FABRICS COMPARISON 39 TYVEK 500 x 500 x MICROPOROUS FILM BARRIER LAYER BARRIER LAYER 200 x 200 x
CLOTHING FABRICS COMPARISON 40 TYVEK SMS BARRIER LAYER BARRIER LAYER 200 x BARRIER LAYER BARRIER LAYER High, homogene barrier 0,1 mm Relatively low barrier, only in the middle ( Meltblown, staple fibers) 0,1 mm
CLOTHING FABRICS COMPARISON 41 TYVEK 500 x 500 x SMS BARRIER LAYER BARRIER LAYER 200 x 200 x
42 Chemical protective clothing performance Clothing performance = Fabric plus Design plus Sizing plus Manufacturing quality plus PPE compatibility
43 DuPont Garment Range
44 We cover it all Cat I & Cat III and cleanroom requirements Category I Category III Type 6 Type 5 Type 4 Type 3 Type 2 Type 1
45 Your protection need - our clothing solution Gaseous substances Concentrated inorganic chemicals Organic and highly concentrated inorganic chemicals TYCHEM TK. Dirt Low concentrated inorganic chemicals Particles / Dust TYCHEM C TYCHEM F TYVEK PROSHIELD Rule of thumb
46 PROSHIELD - Product range PROSHIELD 10 (SMMS) Cat. III Type 5, 6 PROSHIELD 30 (Micropor. Film) Cat. III Type 5, 6 PROSHIELD Comfort Cat. III Type 5, 6 PROSHIELD Polyclean (Polpropylen) Cat. I PROSHIELD Proper (Perfor.Tyvek) Cat. I
47 PROSHIELD 10 - Typ 5, 6 3. Material: SMMS Colours: white, blue Sizes: S-XXXL 1. 2. 1. External seams 2. Nylon zipper with storm flap 3. 3. Elasticated hood, cuffs & ankles 4. Sewn-in waist elastic 3.
48 PROSHIELD 30 - Typ 5, 6 Material: MF Colour: white Sizes: S-XXXL 3. 2. 1. 1. Inside seams 2. Zipper with storm flap 4. 3. 3. Elasticated 3-piece hood, cuffs & ankles 4. Sewn-in waist elastic 3.
49 TYVEK - garments TYVEK Classic TYVEK Classic Plus Cat. III Type 5, 6 Cat. III Type 4, 5, 6 TYVEK Industry Cat. III Type 5, 6
50 TYVEK Classic Colour: White Sizes: S-XXXL Colours: Blue, Green Sizes: S-XXL 1. 2. 3. 1. Outside seams 2. Zipper flap 4. 5. 3. Elastic face opening 6. 4. Zipper made of Tyvek 5. Elastic cuffs and ankles 6. Glued in elastic in waist 5.
TYVEK Industry 51 Colour: White 2. Sizes: S-XXL 3. 1. Glued in elastic in waist 1. 4. 2. Zipper made of TYVEK 3. Zipper flap 4. Elastic cuffs and ankles 5. Inside seams 5. 4.
TYVEK Classic Plus Now available with integrated socks! Thumb loops: now a standard garment feature 52 Colours: White Sizes : S XXXL Green S-XXXL 1. Inside seams and overtaped for increased tightness 2. Zipper made of TYVEK and self adhesive zipper flap for tight closure 3. Elastic face opening especially designed for respirator wearer 4. Elastic cuffs and elastic thumb loop 5. Glued in elastic in waist allowing free movement 6. Socks, with boot flap, to be used inside of safety boots
53 TYVEK accessories Hood Labcoat Shoe covers Sleeves Trousers Boot covers Jacket Apron
TYVEK : accessories range (1) 54 Labcoat made of TYVEK Labcoat made of TYVEK Labcoat made of TYVEK Trousers made of TYVEK Jacket made of TYVEK
TYVEK : accessories range (2) 55 Apron made of TYVEK Hood made of TYVEK Overboots made of TYVEK Overboots with slip retardant sole made of TYVEK
TYVEK : accessories range (3) 56 Sleeve made of TYVEK Overshoes made of TYVEK Overshoes with slip retardant sole made of TYVEK
57 TYCHEM fabrics TYCHEM C yellow olive green TYCHEM F grey orange olive green
58 TYCHEM fabrics: Barrier Chemical Particle Concentrated inorganic chemicals particle tight Organic and highly concentrated inorganic chemicals Liquid* 2 bar 5 bar Biological * Based on burst results Fulfill all requirements for protection against biological hazards according to EN 14126 in the highest performance class
59 Summary Tychem C, Tychem C2 Tychem F, Tychem F2
60 TYCHEM C, TYCHEM C2, TYCHEM F, TYCHEM F2 Wearer comfort Lightweight Low basisweight compared to other barrier fabrics with similar barrier performance
61 TYCHEM C, TYCHEM C2, TYCHEM F, TYCHEM F2 Chemical Protection 100 % particle tight TYCHEM C + TYCHEM C2 protection against concentrated inorganic chemicals TYCHEM F + TYCHEM F2 protection against organic and high concentrated inorganic chemicals
62 TYCHEM C, TYCHEM C2, TYCHEM F, TYCHEM F2 Protects against electrostatic charging Antistatic treatment of inside surface Fulfils the requirements for chemical protective clothing - EN 1149-1:1995* (*) will change to pren 1149-1:2004 and pren 1149-5:2005 NB. The antistatic treatment is only effective when relative humidity is > 25%. Garment and wearer need to be properly grounded. In case of inhomogenous fabrics the antistatic treatment need to be applied to one sidfe only.
63 TYCHEM C, TYCHEM C2, TYCHEM F, TYCHEM F2 Protects against Biological Hazards meet the EN 14126: 2003 requirements in the highest performance class.
64 TYCHEM C Consisting of TYVEK substrate plus polymer coating TYVEK Polymer coating
TYCHEM C : Coveralls Colours: Standard model: Yellow and green Model with socks: Yellow 65 Sizes: S-XXXL 1. Hooded coverall. 2. Elasticated hood and self-adhesive chin flap for tight fit around respirator. 3. Double self-adhesive zipper fl ap offers high level of protection. 4. Elasticated cuffs and ankles. 5. Elasticated waist for better fi t of garment. 6. Stretch rubber thumb loop attached to the end of the sleeve. Also available with integrated socks!
66 TYCHEM F Consisting of TYVEK substrate with special DuPont barrier film laminate TYVEK Polymer coating Barrier film Polymer coating
TYCHEM F : Coveralls Colours: Standard model: Green, grey & orange and green Model with socks: Grey 67 Sizes: S-XXXL 1. Hooded coverall. 2. Elasticated hood and self-adhesive chin flap for tight fit around respirator. 3. Double self-adhesive zipper fl ap offers high level of protection. 4. Elasticated cuffs and ankles. 5. Elasticated waist for better fi t of garment. 6. Stretch rubber thumb loop attached to the end of the sleeve. Also available with integrated socks!
TYCHEM ACCESSORY RANGE 68 SLEEVES OVERBOOTIES APRON SURG. GOWN MODEL FEATURES Wide elastics at cuffs and upper arm for comfortable fit. Slip retardant overboot, Apron with flap Neck and waist ties Gown style apparel for front protection with closure in back 50 cm length Knee length Shin length Elasticated cuffs Shin length Single size Single size Single size S/M and L/XXL
TYCHEM ACCESSORY RANGE 69
Sontara MicroPure Helps you to keep your cleanroom clean and indicate trademarks or registered trademarks of DuPont or its affiliates
71 Product range ISO 14644 ISO-3 ISO-4 ISO-5 ISO-6 ISO-7 ISO-8 US Fed.Std. 209 1 10 100 1 000 10 000 100 000 GMP-Leitfaden EU A/B C D Sontara MicoPure 100 Sontara MicoPure AP The wipe for critical applications. The all purpose wipe. Sontara MicoPure SV The wipe for less demanding applications. Sontara MicoPure MOP The wipe for floor cleaning. Requirements for wiping and cleaning levels may vary. Choosing the appropriate wipe depends on many factors, such as for example: the surface to be cleaned (smooth or rough, edges or without edges, etc.), the required level of cleanliness, procedures employed and others. Choosing the appropriate wipe is critical to product quality and not putting your image at risk
72 Product range Product Sontara MicroPure AP Sontara MicroPure100 Sontara MicroPure SV Sontara MicroPure MOP Wipes/ Dimensions mm Package 224x224 300 305x305 150 224x224 300 305x305 150 457X457 75 224x224 500 305x305 250 457x457 75 300x590 500 500x590 500 400x700 500 290x400 500
73 Sontara MicroPure Your benefits Cleanliness Consistent quality Absorbency
74 Our services to assist you -Technical Hotline: gives you written recommendations for the chemicals you are working with - Training video on correctly donning & doffing -Detailled literature: technical handbook, cleanroom brochure, etc. - Regularly updated website -Seminars & onsite visits by regional product specialists
75 Thank you for your attention