Classifications

• • A—HUMAN NECESSITIES
  • A62—LIFE-SAVING; FIRE-FIGHTING
  • A62D—CHEMICAL MEANS FOR EXTINGUISHING FIRES OR FOR COMBATING OR PROTECTING AGAINST HARMFUL CHEMICAL AGENTS; CHEMICAL MATERIALS FOR USE IN BREATHING APPARATUS
  • A62D5/00—Composition of materials for coverings or clothing affording protection against harmful chemical agents
• • A—HUMAN NECESSITIES
  • A41—WEARING APPAREL
  • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
  • A41D31/00—Materials specially adapted for outerwear
  • A41D31/04—Materials specially adapted for outerwear characterised by special function or use
  • A41D31/30—Antimicrobial, e.g. antibacterial
  • A41D31/305—Antimicrobial, e.g. antibacterial using layered materials
• • A—HUMAN NECESSITIES
  • A62—LIFE-SAVING; FIRE-FIGHTING
  • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
  • A62B17/00—Protective clothing affording protection against heat or harmful chemical agents or for use at high altitudes
  • A62B17/006—Protective clothing affording protection against heat or harmful chemical agents or for use at high altitudes against contamination from chemicals, toxic or hostile environments; ABC suits

Definitions

• the present invention refers to clothing suitable for the protection against biological agents.
• the infective agents are usually well known.
• the agents the workers are exposed may not be known and only possible risks can be assessed; this happens, for example, in agriculture works, waste treatments, in particular hospital wastes, veterinary laboratories, emergency clean-up.
• Protective clothing can be made by reusable materials as well as by single-use materials.
• Single-use protective clothes are commonly constructed of nonwoven materials, which rely on fiber bonding technologies (thermal, chemical or physical) to provide integrity and strength.
• the basic raw materials are various forms of natural (for example cotton and wood pulp) and synthetic fibers (for example polyester and polyolefin).
• Fibers can be engineered to achieve desired properties by the use of particular fiber types, bonding processes and fabric finishes.
• fibers can be bonded mechanically, by high-velocity water jets which entangle the fibers (spunlace), thermally, by in-line melt spinning (spunbond), or chemically, by chemical binders (wet laid ).
• spunbond fabrics are made of polyolefins.
• Both reusable and single-use products are often reinforced to enhance or improve their properties; for particular applications, additional materials are often added (overall or zoned) in the form of additional layers of materials, coatings, reinforcements or laminates.
• a second layer of fabric is sometimes used to improve resistance to liquid penetration and skid resistance or chemicals are used to provide reinforcements and liquid-proof characteristics.
• Various protective clothes obtained by the above processes have been described: for example in EP 0 365 559 Bl (priority GB 8714535).
• Polyethylene is one of the most used materials, produced in several types for different applications.
• Tyvek brand protective material is a spundbonded olefin manufactured from very fine continuos filaments of high-density polyethylene bonded together by heat and pressure. These materials are described, for example, in EP 850330 and US 4321781.
• the clothings of the present invention are overall, jacket and trousers which provide a very high level of protection against the penetration of liquids and microorganisms, excellent mechanical properties, including tear and abrasion resistance, outstanding softness, drapeability and comfort. DESCRIPTION OF THE INVENTION
• the invention relates to novel clothing suitable for the partial protection of the body against biological agents.
• the clothing consists in a layer of nonwoven material in polypropylene laminated with a polyethylene film, wherein the ratio in unit weigth between polypropylene and polyethylene ranges from 70:30 to 50:50, preferably from 65:35 to 55:45.
• the clothing is typically made of a layer of nonwoven polypropylene, having thickness ranging between 240 and 270 microns and unit weigth ranging between 35 and 45 g m 2 , laminated with a polyethylene film having thickness ranging between 30 and 70 microns and unit weigth ranging between 20 and 30 g/m 2 .
• the total thickness of the material is in the range 270-340 microns while the unit weigth ranges between 55 and 75 g/m 2 .
• the clothing is preferably made of a layer of nonwoven polypropylene, having thickness in the range 245-255 microns and unit weigth ranging between 37.5 and 40.0 g/m 2 , laminated with a polyethylene film having thickness ranging between 40 and 60 microns and unit weigth ranging between 22.5 and 27.5 g/m 2 ; the preferred thickness of the clothing is in the range 285-315 microns while the unit weigth ranges between 60.0 and 67.5 g/m 2 .
• the inner layer consists in a nonwoven spunbonded material made up of continuos filaments of polypropylene.
• the inner layer besides providing a barrier against liquids and microorganisms, ensures high drapeability and comfort and, in addition, is physiologically safe and breathable.
• the outer layer is made of a microporous polyethylene film with pore size low enough to prevent the passage of liquids and microorganisms but, at the same time, to allow moisture to pass on a molecular level, so ensuring a good breathability.
• the combination of the two materials in the respective forms and in the appropriate ratios provides a combination of chemical-physical properties and of drapeability and comfort never reached with the clothing for partial body until now known.
• the softness of the material which ensures the high drapeability and the excellent comfort in any situation, does not negatively affect the barrier properties against liquids and microorganisms, which, on the contrary, turn out to be equivalent or superior in comparison to the known materials with higher density.
• the tear and abrasion resistance are strong enough to withstand the stresses encounterd during any critical condition of use.
• the clothing object of the present invention consists in overall, jacket and trousers.
• the clothing has been designed to comply with the specific requirements of the existing rales, in particular to comply with the
• the forge ensures only the protection of specific parts of the body so that the clothing must be worn together with gloves and other protective apparel in order to ensure the protection of the remaining parts of the body.
• the overall and the jacket of the present invention can be coupled with the trousers of the present invention.
• Fig. 1 illustrates, as an example, the drawing of the overall; on the front side (la), it protects the exposed parts of the body, such as the base of the neck, the bust, the arm and the legs as far as the knee.
• the overall is equipped with rubber bands round the wrists which perfectly stick to the wrists in order to isolate arms from contact with potential hazards. All the joining parts are assembled by heat welding; the seams ensure an high barrier, equivalent to the material's one.
• the overall is opened on the back side (lb) to let that easily put on and can then be closed by four rear fastening means, two in the inner side and two on the outer side.
• the clothing is fabricated and designed to avoid area which could irritate or adversely affect the user.
• the clothing is fabricated in several sizes in order to be comfortable for any worker in any working situation and to prevent the cloth to be damaged.
• the dimensions, in cm, of the different sizes of the overall comply with the EN 340 rule and are listed in the following table, with a tolerance of +/- 3%.
• Size small medium large length 110 120 130 thorax circumference 130 134 140 shoulder width 56 59 62 sleeves width 58 59 62
• the measurements have been carried out in normal environment at 20°C and 65% R.H., in agreement with the test method ISO 3635/'81.
• the process of manufacture is based on the standard rules for manufacturing protective clothing.
• the material is cut and hollow punched, the different parts are selected on the basis of the different size and are then marked by numbers.
• the dimensions of the different parts are then checked and the clothing is manufactured by heat welding the different components. A label is then applied inside the clothing.
• the label besides the producer's name, contains, among others, the model name, the standard picture-writing, the size, the "biological hazard" picture-writing.
• the clothing is marked in accordance with the European Standard (CE) for protective clothing against biological agents.
• CE European Standard
• the information for the user are worded clearly and unambiguosly and the CE marking is clearly evident to guarantee the accordance with the fundamental safety and healthy requirements;
• fig.2 shows an example of label.
• controls are carried out to check that all the parts have been correctly assembled and that the superimposition of the different layers as well as the composed structures are in compliance with the operative instructions.
• the so manufactured clothing is suitable for the protection against biological agents as bacteriae, parasites, fungi and viruses.
• the clothing is effective against any microorganism, including whose which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity.
• the clothing is effective against microorganisms that can be transmitted by blood and body fluids, such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Viruses (HIV), against the agents specific for BSE and other TSE, and against the Bacillus Anthracis.
• HBV Hepatitis B Virus
• HCV Hepatitis C Virus
• HCV Human Immunodeficiency Viruses
• the clothing can be used in any situation in which the workers are possibly exposed to different kind of dangerous substances in various forms, like liquids, air, aerosols or solids.
• work situations with risk of exposure to infective agents are the biotechnological productions, the work in health care (including isolation and post-mortem units), the work in chemical-biological, veterinary and diagnostic laboratories, the work in refuse disposal plants, the activities where there is contact with animals and/or products of animal origin.
• the clothing may be worn over the usual working clothes and its effectiveness is guaranteed only if it is correctly worn, fastened and of appropriate size.
• results of some tests, carried out to evaluate the technical properties of the overall are reported. Such results have only illustrative aim and they do not imply any limitation.
• the primary performance of a protective clothing is the effectiveness in providing the appropriate level of protection against the penetration of microorganisms.
• Liquids are generally accepted as the most important vector of microbiological transport but other possible vectors include air and aerosols; in addition, also dry penetration of microorganisms promoted by mechanical action may also be possible.
• an effective microbial barrier must be resistant to both wet and dry penetration of microorganisms.
• tests 1-3 A series of tests (tests 1-3) have been carried out to determine the barrier properties of the overall of the present invention.
• the test measures the resistance of materials to penetration by blood- borne pathogens using a surrogate microbe under conditions of continuos liquid contact.
• the test is divided in two parts: a) the material is subjected to successive increasing levels of pressure, using synthetic blood which simulates blood and other body fluids; penetration of the synthetic blood through the material is observed visually. Part a) is used as a screening test. b) the resistance of the material to penetration by a surrogate microbe is measured, the surrogate microbe being a microorganism which acts as simulant for other microorganisms which are pathogenic to humans.
• the synthetic blood simulates body fluids; many factors can affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity and polarity of the fluid.
• the surface tension range for blood and body fluids (excluding saliva) is approximately 0.042-0.060 N/m.
• the surface tension of the simulant is adjiusted to approximate the lower end of this surface tension range, that is 0.042 (+/-0.002) N/m.
• the surrogate microbe used in the test is the Phi- 174 Bacteriophage, which is not pathogenic to humans but serves to simulate viruses that are pathogenic to humans.
• Test results la) screening test-resistance to synthetic blood This test method covers the determination of the resistance of protective material to penetration by biological liquids, using synthetic blood at different levels of hydrostatic pressure.
• the test is based on ASTM F 1670 and is used as screening test.
• the test has been run on three specimens of 75 mm x 75 mm, taken at random, at a temperature of 25 (+/- 5) °C, with 52% relative humidity and each pressure is hold for 5 minutes.
• Phi-X174 Bacteriophage The test is used to measure the resistance of protective materials to penetration by infective agents, using the bacteriophage Phi X-174 as a test system.
• test only applies to materials that pass the screening test a) and is based on ASTM F 1671.
• the specimens were subjected to a nutrient broth, containing the virus, to which successive pressure levels were applied, for 5 minutes each, at a temperature of 21 (+/- 5)°C.
• the specimen passes the test when the pfu/ml (plaque forming units per milliliter) which penetrate through the specimen at a given pressure are ⁇ 1; the material passes the test at a given pressure level when all three specimens pass.
• the test has been carried out by a Perspex box with Collison atomiser.
• NCIMB 9518 NCIMB 9518
• Underpressure is used to collect the droplets of the contaminated aerosol on two membrane filters.
• One of these filters has been shielded by the protective clothing material.
• the test is based on EDANA method 190.0-89/'96.
• a powder has been contaminated with spores of Bacillus Subtilis ATCC
• the number of microorganisms penetrated through the material was counted after 24 hours incubation at 35°C.
• the test was carried out on six, 200 mm x 200 mm, specimens, one of which used as an uncontaminated control.
• tests 4-28 Some tests (tests 4-8) have been carried out to assess the mechanical properties of the clothing.
• Abrasion resistance The abrasion resistance was determined using 00 abrasive paper by the
• the method classifies the materials in 4 classes, the highest classification, level 4 (> 500 cycles), denoting materials with the highest abrasion resistance.
• the material of the present invention shows the highest resistance to damage during use.
• the test is based on EN 1146/'97 method, using a 40 mm high flame, with a temperature of 800 (+/- 50) °C, obtained by propane gas and by a bunsen according to the EN/532/' 94 rule.
• the material during the normal use, may come into contact with chemical agents such as clinical liquids, skin disinfectants, lubricants, oils.
• the protective clothing has an appropriate resistance against chemicals.
• the test is based on UNI EN 20811/'93 method, using a TEXTTEST FX 3000 apparatus and increasing the water pressure at a rate of 60 cm per minute. The test was carried out at 20 +/- 2 °C and 65 % R.H. with a water temperature of 20 +/- 2 °C.

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• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Toxicology (AREA)
• Health & Medical Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Materials Engineering (AREA)
• Textile Engineering (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Business, Economics & Management (AREA)
• Emergency Management (AREA)
• Professional, Industrial, Or Sporting Protective Garments (AREA)
• Respiratory Apparatuses And Protective Means (AREA)
• Laminated Bodies (AREA)

Applications Claiming Priority (3)

Publications (1)

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• 2002
  • 2002-11-14 IT IT000023A patent/ITPS20020023A1/it unknown
• 2003
  • 2003-11-11 CN CNA2003801033591A patent/CN1711118A/zh active Pending
  • 2003-11-11 BR BRPI0316369-5A patent/BR0316369B1/pt not_active IP Right Cessation
  • 2003-11-11 EP EP03780627A patent/EP1560632A1/en not_active Withdrawn
  • 2003-11-11 AU AU2003288724A patent/AU2003288724A1/en not_active Abandoned
  • 2003-11-11 JP JP2004551163A patent/JP2006507416A/ja active Pending
  • 2003-11-11 CA CA002506079A patent/CA2506079A1/en not_active Abandoned
  • 2003-11-11 WO PCT/IT2003/000729 patent/WO2004043544A1/en not_active Ceased
  • 2003-11-11 PL PL376773A patent/PL376773A1/pl not_active Application Discontinuation

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