ANTIMICROBIAL FABRICS – AN OVERVIEW Brian McCarthy, Materials KTN and Simon Burnett-Boothroyd,...
Transcript of ANTIMICROBIAL FABRICS – AN OVERVIEW Brian McCarthy, Materials KTN and Simon Burnett-Boothroyd,...
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ANTIMICROBIAL FABRICS – AN OVERVIEW
Brian McCarthy, Materials KTN and Simon Burnett-Boothroyd, Nylatex Limited
9th November 2009IOM3
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DEFINITION
An anti-microbial agent is defined as a natural or synthetic substance which kills or inhibits the growth of micro-organisms such as bacteria,
fungi and algae
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Biocidal Products Directive(98/8/EC)
Formally published in Official Journal of the European Communities (Vol 1213) on 24th April 1998
Member States required to implement BPD by 14th May 2000
Final closing date for existing substances 26th September 2002
Main Product Groups:
1 - Disinfectants and general biocidal products (PT1-6)
2 - Preservatives (PT6-13)
3 - Pest control (PT14-19)
4 - Other biocidal products (PT20-23)
Total Product types – 23
Actives authorised at EU level (Final submission date : 1st August 2007)
Products authorised at National Level (At a charge)
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EU Definition of a Treated Article / Material
The combination of an article and an active substance, if the active substance is placed on the market as an inseparable ingredient of the article, has to comply with the requirements of the Directive if it is intended that the biocidal active substance is released from the treated article to control harmful organisms outside the treated article (external effect)
or
If it is intended to control only organisms that are not harmful to the treated article itself.
In such cases, the article has the function of a delivery system and shall be considered as a biocidal product that must be authorised.
Decision of EU Competent Authorities July 2005 :
Treated Materials / Articles - Product type 2 (Now?)
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BPD Product Type 2 Definition
Product‑type 2:
Private area and public health area disinfectants and other biocidal products.
Products used for the disinfection of air, surfaces, materials, equipment and furniture which are not used for direct food or feed contact in private, public and industrial areas, including hospitals, as well as products used as algicides.
Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air‑conditioning systems; walls and floors in health and other institutions; chemical toilets, waste water, hospital waste, soil or other substrates (in playgrounds).
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BPD State of Play
Biocidal Products Directive (BPD)Identified Actives: 1,500+
Notified Actives: 800+Dossiers submitted to date: ~1/2 of those anticipated
Therefore likely to be ~400 in total
Low level of awareness / implications within the textile industry
REACHCovers ~30,000 chemicals
Came into Force on 1st June 2007Registration by company so 100,000+ anticipated
Pre-Registration June - December 2008Will cover some aspects of agents authorised under the BPD
Note: Both Directives call for the substitution of the most dangerous chemicals when
suitable alternatives have been identified.
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Examples of Treated Articles
Mosquito nets containing insect repellents
Insecticidal strips treated with insecticides
Mattress covers that are labeled as anti mite for use in prevention of the action of house mites outside the cover (i.e. within the mattress)
Impregnated tissues with “antibacterial” properties (if not regarded as medicinal products, e.g. for certain applications in hospitals)
Antibacterial lavatory seats where the active substance is released during use.
Sleeping bag treated with an insect repellent.
Socks treated with a biocidal active substance intended to have a biocidal action on the foot.
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Current Efficacy Test Methods
Country / Geography
Test Reference Use Site (optimal matrices)
Test Parameters
Test Organisms Contact Time
Exposure Solution, temperature
USA AATCC Method 174-Part II
Hydrophilic/absorbent textiles, foams
K. pneumoniae ATTC 4352 and S. aureus ATCC 6538
24hrs “nutrient broth”, saline or other; 37C
AATCC Method 100 Hydrophilic/absorbent textiles, foams
K. pneumoniae ATTC 4352 and S. aureus ATCC 6538
24hrs “nutrient broth”, saline or other; 37C
Draft Method of AATCC (based on NYS-63)
Hydrophobic textiles, plastics
K. pneumoniae ATTC 4352 and S. aureus ATCC 6538
24hrs “Nutrient Broth”, saline or other; 37C
ASTM Method E2149-01 (Shake Flask)
All; High volume to sample ratio
K. pneumoniae ATTC 4352 1 and 24hrs
0.3mM phosphate buffer or other; 25C
ASTM Method E2180-01 (Sloppy Agar)
Hydrophobic textiles, plastics
K. pneumoniae ATTC 4352 and S. aureus ATCC 6538
24hrs 0.3% agar slurry in saline; 37C
Japan JIS L 1902 - quantitative Hydrophilic/absorbent textiles, foams
K. pneumoniae ATTC 4352 and S. aureus TCC 6538P
18hrs 5% “nutrient broth” in saline; 37C
JIS Z 2801 Hydrophobic textiles, plastics
E. coli ATTC 8739 and S. aureus ATCC 6538P
24hrs 0.2% “nutrient broth” in distilled H2O; 35C
Switzerland SNV 195124 Most matrices, depends on migration of biocide?
K. pneumoniae ATTC 4352 and S. aureus ATCC 6538
24hrs??
France XPG-39010 All; targeted for textiles K. pneumoniae ATTC 4352 and S. aureus ATCC 6538
18-24hrs
0.1% Tryptone in saline; 37C
Europe Draft Method of IBRG Plastics Group
Hydrophobic textiles, plastics
E. coli ATCC 10536, P. aeruginosa ATCC 15442 and S. aureus ATCC 6538
24hrs Not finalized; 23C
“Shake Flask” Method (BISFA) - quantitative
All; High volume to sample ratio
K. pneumoniae ATTC 4352 1, 6 & 24hrs
0.3mM phosphate buffer or other; 25C
Germany
“Unified Method”; not published but used by Hohenstein Institute
Hydrophilic/absorbent textiles, foams
K. pneumoniae ATTC 4352 and S. aureus ATCC 6538
24hrs 5% “nutrient broth” in saline; 37C
*** Japan is only current country with performance standards (voluntary)
All these are quantitative methods targeted for bacteria (Gram negative and Gram positive)
** Recommendations for initial bioburden range between 105 and 106 viable cells/ml
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Harmonisation of Efficacy Requirements
OECD – Task Force For Biocides
Workshop Recommendations: 1) The working group recommends an acknowledgement that treated materials may be part of an overall hygienic practice rather than substitutes for products that sanitise, disinfect or sterilise
2) The working group recommends that any anti-microbial claims for treated materials MUST be supported by scientifically sound quantitative efficacy data
Future:There will be a 3 tier testing approach Tier 1 : Proof of PrincipleTier 2 : Simulated Laboratory StudiesTier 3 : Field Test Data
Acceptable methodology types for Tier 1 are available (porous & non-porous)
Work is ongoing within OECD to develop a Guidance Note
Additional Needs: Dry methods / Fungal methods / Biofilm challenge / Recovery efficiency AND Resistance development
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Points to Note
Efficacy Data MUST support the product claim(s)
Any Data MUST be quantitative
Requirement to show BENEFIT of the treated article
Concern around long term low levels of biocide in the environment giving rise to enhanced development of resistant microorganisms
WITH
Potential for development of cross resistance with antibiotics
SIAA (Japan) have requested assistance from IBRG and are working together to develop JIS 2801 as an ISO standard
Recommendation that all manufacturers of treated articles to get confirmation from their active(s) manufacturers that the active(s) in question are being supported by them through the EU’s authorisation process.
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An Industrial View
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The top 5 ways that Hospital Infections can be acquired
1. Blood Infections - Highest associated mortality 6%
2. After Surgery 11%
3. Urinary tract infections - Most frequent 23%
4. Chest Infections 23%
5. Skin Infections 10%Report from the committee of public accounts, The management and control of hospital acquired infection in Acute NHS Trust in England (hc306,Session 1999-2000)Paras 1-2; Ev.34
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Reducing HAI Infections
• Identify the sources of infection– MRSA carriers on admission to hospital– MRSA infected patients– Environmental
• Break the routes of transmission to other patients– Isolation of carriers/infected patients– Decolonization of MRSA carriers (mupirocinR?)– Hand hygiene compliance is vital (soap vs alcohol)– Environmental cleaning – kill C.difficile spores– Better information for staff/patients/visitors
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MRSA carriage transmission
Hospitals
CommunityResidential housesCare homes
MRSA carriers
MRSA carriersMRSA transmission
discharge
PetsPigs?Vets
Patients with infected wounds are an important source of transmission.Important role for medical textiles here.
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The Industrial view
Quote!
“Understand your enemy & understand yourself” Sun Tzu
• Raw Material selection (Natural / Synthetic)• Manufacturing process
• Quality Control • Fit for purpose – Robustness & Cost
implications• Legal & Environmental Issues
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Material deployment for Infection prevention:
1. Scatter Gun approach – Every Surface and Material in contact within the Healthcare setting.
2. Focused Application (Consider whom is at risk!)• Surgical compliant to the standards (EN13795)• Surgical procedure / Wound management (open and
closed) • Work wear – Uniform & Day wear for employees? (Short
Sleeves) • Patient Application – Modesty gown / Compression
Therapy • Ward surrounding – Curtains / Blinds / Bed linen / Floor’s,
Ceilings? Entrance and Access points ?
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Impact on the Healthcare Pathway
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New Active Antimicrobials in the European Union
The BPD is an excellent, though costly, and time consuming way of regulating these highly biologically active substances
However Development in the EU of Innovative Novel Actives has now effectively stopped (BUT not in Japan or the USA)
The EU Commission & Member States need to find a way to assist the Development of New Actives with Lower Environmental Impact
Remember
The EU Biocides industry is ~0.1% of the EU chemical industry
BUT
Biocides Protect ~50% of its Production
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ANTI-ODOUR CLOTHING
Provides hygiene, freshness and
sense of well-being
Sportswear, socks and footwear
Now standard treatment
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Types of Material
CHEMICAL TREATMENTS
e.g. Silver
Antibacterial properties
Or
Natural fibres e.g. Bamboo with inherent antimicrobial properties
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ODOUR MANAGEMENT
Effect achieved using anti-microbial-treated textiles – often referred to as bioactive textiles
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ANTI-MICROBIALS
Added to textiles to prevent biodeterioration
e.g. staining, odour, discolouration and physical damage
Now added to protect end-users
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TRENDS
Surge in demand in recent years
• Rise in participation in outdoor activities• Awareness of the benefits of hygiene
• Prolonging the freshness of cleaned clothes
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UK SURVEY
50% of males and 45% of females would pay more for bioactive textiles
Taylor Nelson Sofres - 2007
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BAMBOO
Tested in 2003 by the China Textile Industry Testing Centre –
Killed 99.8% of introduced bacteria after 24 hours – much greater than the effect produced by
cotton
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CHITOSAN
Applied to sportswear, socks and underwear
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APPLICATION
Protect the wearer by:
• Preventing odour production• Limiting skin infections by fungi
• Limiting microbes responsible for disease
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APPLICATION
• Into the polymer solution prior to extrusion
• Chemical bonding to the fibre surface
• During textile finishing – non-durable
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GROUPS
Organic or inorganic
Bound or unbound
Bactericides or fungicides
Bacteriostats
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Organic vs. Inorganic
Organic • Triclosan
• Polyhexamethylene biguanide (PHMB)
Inorganic• Silver, copper, zinc
• oxidants
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SILVER
Claims that silver will kill over 650 types of pathogenic organisms
• Anti-odour• Anti-static
• Temperature regulating
• Underwear, sportswear, military textiles, protective clothing, medical textiles
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Anti-microbial (bioactive) Textiles
Market
Global – 600,000 tonnes
EU – 150,000 tonnes
(2005)
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Major End Use Applications
35% Bedding
30% Medical
25% Hosiery, socks and underwear
10% Sportswear
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BIOCIDE PRODUCERS
Aegis
Agion Technologies
Arch Chemicals
Halosource
Microban
Milliken
Sanitized
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ANTIMICROBIAL FIBRES
Noble Biomaterials
Amicor
Toray
Trevira
Klopmann
Carrington