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A.MURALIKRISHNAN
LECTURER – TEXTILES
P.A.C.RAMASAMYRAJA POLYTECHNIC COLLGE,
RAJAPALAYAM, TAMILNADU, INDIA
Email: [email protected]
Contents
• Introduction
• Personal protective equipments (PPE)
• Types of protection levels
• Classification of masks
• Functional, design, ergonomic requirement, • Functional, design, ergonomic requirement, manufacturing method for surgical face mask
• Difference between respirator and surgical face mask
• Construction of respirator
• Testing and Evaluation methods
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Personal protective equipment
(PPE)
• "PPE", is equipment worn to minimize exposure to a
variety of hazards.
• PPE also referred to as “equipment designed to
protect the wearer's body from injury or infection”.protect the wearer's body from injury or infection”.
• The hazards may be from physical, electrical, heat,
chemicals, biohazards, and airborne particulate
matter
• Examples of PPE: Masks, gloves, ear plugs, helmets,
goggles, full body suits and etc.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
What is P1 or P2 Protection?
• P1 - For filtering mechanically generated particles
– Which meets AS/ NZS1716:2003
– Example : particles formed by crushing, grinding, drilling,
sanding and cutting.
• P2 is - for filtering mechanically and thermally generated • P2 is - for filtering mechanically and thermally generated
particles
– Which meets AS/NZS1716:2003,
– Example: Welding fume, against some bio aerosols such as
H1N1 and H5N1 Influenza.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Classification of face mask
• Based on the function
– Comfort mask
– Surgical face mask
– Surgical Respirators– Surgical Respirators
– Particulate respirators
• Based on usage
– Disposable
– Reusable
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Selection of suitable mask
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Size of various particles
The following particles are more dangerous to human
health
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Surgical masksIntroduction:
• A surgical mask is a loose-fitting, disposable device that creates
a physical barrier between the mouth/nose of the wearer and
potential contaminants in the immediate environment.
• It also prevent patients from direct transmission of infectious
agents from health care professionals or the surgical area.
• Surgical masks are not PPE as defined under the European
Directive 89/686.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Functional requirements of surgical
mask
• Prevent the spread of infection between sick and well persons
– Simple surgical masks should protect wearers from being
splashed with body fluidssplashed with body fluids
– Prevent transmission of body fluids from the medical
professional to the patient.
• Should have sufficient filtration efficiency to Bacterial and
aerosol particles.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Design Requirements• Should have fluid proof and splash resistance to blood and
body fluids
• Should have pleats/folds – For allowing the user to expand the
mask so as to cover the nose and under the chin.
– Commonly 3 pleated are used
• Should have stability during breathing,
– i.e. The mask should maintain its shape in a better way during breath.
• Should have minimum pore size for efficient filtration
• In case of higher filtrations, 3 ply material is made up from a
melt blown placed between spun bonded non-woven fabric,
– the melt-blown material acts as the filter that stops
microbes from entering or exiting the mask.
• Should have additional filtration media for effective filtration
(Optional)Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Ergonomic requirements
• Should be breathable and have less breathing resistance.
• Loosely cover the mouth and nose
• It should have two headbands, nose foam and nose clip.
• Should have elastic strap band instead of tie-on strap.
• Made of soft materials and be comfortable to wear.• Made of soft materials and be comfortable to wear.
• Should be light in weight
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Aesthetic requirements
• Different in colour
• Masks with designs for attracting kids
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Flow chart of face mask production
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Structure of surgical Mask
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Filtration fabric manufacturing
• Nonwovens are basically used for purifying
aerosol impurities in the form of solid or liquid
particles.
• The disposable facemasks are made up of spun • The disposable facemasks are made up of spun
bond and melt blown nonwovens.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Spun bonded Non woven fabric
• Raw materials:
– polyethylene terephthalate (PET) and polypropylene.
• Bonding method:
– Thermal bonding or resin bonding
– Bonding should be throughout the web
• Benefits• Benefits
– Soft on skin
– Disposable
– Air permeable
– Water proof
– Can be sanitized
– Easy to stitch
• GSM Range: 15 - 30Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Properties of Spun bond non woven
fabric
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Melt blown non woven fabric• Composed of super-thin, non-continuous fibres.
• Melt- blown nonwoven are characterised by random
arrangement of fibres.
• Stability is achieved mainly by the cohesion forces, as the
fibres are mutually glued during solidification.
• Polypropylene (PP) has a low melting point and is the most • Polypropylene (PP) has a low melting point and is the most
popular polymer for melt-blown nonwovens.
• The following polymers can also be used:
– polyethylene terephthalate (PET),
– polyamide (PA) and its copolymers,
– polyethylene (PE),
– polycarbonates (PCs),
– simple and complex polyurethanes (PU).Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Properties of MB fabric
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Classification based on performance
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
What should I know before using surgical
masks?
• Surgical masks will not fully protect you from being infected.
• Masks must be changed when they become wet with saliva or other bodily
fluids, as they lose their protective properties.
• Surgical masks are not tested against specific requirements. • Surgical masks are not tested against specific requirements.
• Never reuse, wash or disinfect surgical masks.
• Never share surgical masks with others.
• Place used or soiled masks into a tied plastic bag to prevent dripping.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Respiratory Protection
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Introduction• The typical respiratory rate for a healthy adult at rest is 12–20
breaths per minute.
• A 70 kg human breathes 20 m3 /day. This shows the
importance of air purification in human life.
• Air pollution from dust is an essential threat to human health.
• The process of removal of dispersed particles in the air by the
porous medium is called filtration.porous medium is called filtration.
• Dispersed particles may be solids or liquids, whereas the
dispersing medium may be gas (mostly air) or liquid.
• Nonwovens are the basic material used for purifying air from
aerosol impurities in the form of solid or liquid particles.
• The porous media used in the filtration process are
differentiated by structure, which can be fibrous, granular,
and capillary.Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Difference between masks and respirators
Surgical masks Respirators
Surgical masks are not PPE Respirators are PPE
Surgical masks prevent droplets being
expelled into the environment by the
used to reduce the potential contact of
the wearer to airborne hazardous expelled into the environment by the
wearer and protect patients and
operative site.
the wearer to airborne hazardous
contaminants.
Un valved: Valved:
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Classification of Respirators
• FFP1 respirators – Suitable for lower filtering
efficiency and protection factor.
• FFP3 respirators - For highest levels of
filtering efficiency and protection factor. filtering efficiency and protection factor.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Respirator fabric Structure• It consists of 3 layers
– Nonwoven needle felt or melt blown middle layer
– Surrounded by spun bonded inner and outer layer.
• The structure and design of the multilayer materials depend
on their application.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Needle punched filter fabric
Influencing parameters on filtration efficiency:
• Fibre diameter, areal density, thickness of the filtration layer,
and the fibre blend's composition
• Effect of filtration is maintained by these non woven are at
least five months after manufacturing. least five months after manufacturing.
• The air flow resistance for the above-mentioned nonwovens is
not higher than 51 Pa.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Particulate Respirators
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Valved Respirators
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Specifications of Respirators• An N95 respirator – PPE designed to achieve a very close facial
fit and very efficient filtration of airborne particles.
• The following notations are called for respirator description.
– N – Not Resistant to Oil
– R – Somewhat Resistant to Oil
– P – Strongly Resistant to Oil (Oil Proof)– P – Strongly Resistant to Oil (Oil Proof)
• N95 respirators remove at least 95% of airborne particles with
a size of 300nm (0.3 micron)
• N99 respirators remove at least 99% of airborne particles
• N100 respirators remove at least 99.97% of airborne particles
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
3M - Product description
• The 3M 9004 IN is a dust mask composed of three layers of
filters.
– Outermost layer filters out the largest dust particles,
– Innermost layer preserves the respirator and– Innermost layer preserves the respirator and
– Middle layer is composed of electrostatic filter media.
– It has the ability to filter above 90% of 0.3-micron
particulate dusts. (Scientific research has proven that for
all dust particles sizes, 0.3 micron dust are the most
difficult to filter effectively).
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Testing and Evaluation of
Masks and RespiratorsMasks and Respirators
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Bacterial filtration efficiency
ASTM F2101 • Designed for measuring bacterial filtration efficiency of surgical face
masks using Staphylococcus aureus as the challenge organism.
• A bacterial challenged aerosol is passed through the test specimen
either face side or inner side at a flow rate of 28.3 L/min
• Evaluation of filtration efficiencies related to both patient generated
aerosols and wearer generated aerosols.
• The mean particle size of the bacterial aerosol used in this test is • The mean particle size of the bacterial aerosol used in this test is
maintained at 3.0±0.3 µm as per relevant ASTM specifications.
• Higher BFE, better the protection level.
• Classifications of surgical face masks as per BFE in European standard
EN 14683 is as follows:
– BFE ≥ 95% indicates the Type-I surgical face masks
– BFE ≥ 98% indicates the Type-II surgical face masks.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Breathing resistance (ΔP)
BS EN 13274- 3 – 2001 & EN 143
• Used to determine the resistance of airflow through the
facemask.
• The surgical face mask is subjected to controlled flow of air.
• The difference in airflow pressure of inlet and outlet of the
sample is measured. sample is measured.
• The difference in pressure is divided by the surface area (in
cm2 ) of the sample.
• A lower in breathing resistance indicates a better comfort
level to the end user
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
• Classifications of surgical face masks based on breathing
resistance are as follows:
• For Type-I and II surgical face masks(non-splash resistant
surgical face masks) ≤3.0 mm H2O/cm2 .
• For Type-IR and IIR surgical face masks,(splash resistant
surgical face masks) ≤ 5.0 mm H2O/cm2
• Lower the breathing resistance value per cm2 , higher the
comfort.
• For that, the available surface area of the facemask is
increased and thereby the total area available for ventilation
is increased.
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Splash resistance (ASTM F1862-07):
• Used to determine the penetration resistance of surgical face
masks
• A fixed volume of synthetic blood (stimulant fluid have
equivalent liquid characteristics like surface tension of actual
blood and other body fluids), is aimed at the specimen and
dispersed at a known velocity.dispersed at a known velocity.
• It simulates the impact of blood or other body fluid onto the
specimen.
• Any evidence of synthetic blood penetration on the back side
of the medical face mask constitutes failure.
• Specimen medical face masks are evaluated at a total of three
different velocities corresponding to human blood pressures
of 10.6, 16.0, and 21.3 kPa (80, 120 and 160 mm Hg).
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
• Higher splash resistance, better protection
• Classifications of surgical face masks based on splash
resistance in European standard EN 14683 are as follows:
Splash resistance (ASTM F1862-07):
– For Type-I and Type-II surgical face masks, this test is not
applicable.
– For Type-IR and Type-IIR surgical face masks, the specimen
should be tested under the constant velocity of 120 mm
Hg
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Flammability (16 CFR 1610): Need of flammability test:
• There are many potential ignition sources in the operating
room, including surgical lasers, electrosurgical units,
endoscopic fiber optics and high-energy electro-medical
devices.
• The materials used in operation theatre will burn if high • The materials used in operation theatre will burn if high
intensity heat energy is applied to them, especially in the
presence of elevated oxygen levels.
• Hence, the flammability test for surgical face masks is
essential.
• The standards given below are used to determine the
flammability by class for medical device like surgical face
masks (Guidance for Industry and FDA staff, 2004).
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
• Consumer Product Safety Commission (CPSC) 16 CFR 1610:
Standard for flammability of clothing textiles.
• National Fire Production Agency (NFPA) Standard 702-1980:
Standard for classification of flammability of wearing apparel.
• Underwriters Laboratory (UL) 2154: Fire test for surgical
fabric.
• The flame spread characteristics are classified in terms of
class 1 to class 4 for the above tests. class 1 to class 4 for the above tests.
• For NFPA, class 1 - slow burning
– But as per CPSC standards, class 1 indicates that minimum
of 3.5 sec or more required to ignite and spreading of
flame on the specimen against the standard flame.
• In case of UL standards, test to measure the quantity of
atmospheric oxygen required to propagate the flame while
ignition is caused by an electro surgery unit or laser unit.
Higher LOI, more flame resistantCompiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Summary of
Testing Testing
evaluation
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
Leading Manufacturers in Mask and
Respirators
• 3M
• Midas
• Crosstex
• Moldex• Moldex
• Breathe healthy
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
References
• Textiles for Protection by Richard A.Scott
• Handbook of technical textiles by A Horrocks and S C Anand
• K.P. Chellamani*, D. Veerasubramanian and R.S. Vignesh Balaji
, “Surgical Face Masks: Manufacturing Methods and
Classification” The South India Textile Research Association,
Coimbatore, TN, India
• Respirators selections, <www.3m.com>
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India
THANK YOUTHANK YOU
Compiled by A.Muralikrishnan, Lecturer, P.A.C.Ramasamyraja Polytechnic college, Rajapalayam, Tamilnadu, India