sitra - coe medical textile oe medical textile...

THE SOUTH INDIA TEXTILE RESEARCH ASSOCIATION 13/37, Avinashi Road, Aerodrome Post

Coimbatore- 641014

TRI AS

SITRA - COE MEDICAL TEXTILEBIOLOGICAL TESTING SERVICESSITRA - COE MEDICAL TEXTILE

BIOLOGICAL TESTING SERVICES

ACCURACY

PROMPTNESS

RELIABILITY

About Us

OverviewThe textile materials in the form of fibre, yarn, fabric (woven, non woven, knitted) and garments have generated considerable interest in medical technology and are being used for various biomedical applications. Medical textiles represent the most innovative domain of medical science & textiles due to their close contact with the biological environment. Medical textiles have been a boon to the human healthcare industry where textiles offer a number of constructive and regenerative approaches in the human body. It is not only the structural aspect of the material but also the innovations in medical textiles that have generated enormous interest in the scientific community in bringing in new generation products. The major requirement of the textile materials is the bioreceptivity and biocompatibility at the application site in human beings. Having the Centre of Excellence for Medical Textiles in our premises, it is one of our prime objectives to assist Entrepreneurs, Industrialists, and Academicians to evaluate their textile and non-textile products for their biological characteristics.

The Ministry of Textiles has identified SITRA as a nodal centre in India for Medical Textiles and designated it as a Centre of Excellence for Medical Textiles. With the various textile testing facilities offered at the centre, it also offers biological testings for textile/non-textile related medical products.

SITRA is accredited by NABL* as per ISO/IEC 17025:2005 and the testing services are in accordance with global regulatory guidelines. SITRA carries a good reputation among National and International Institutions for the quality of services it offers.

TRI AS2

SITRA BIOLOGICAL TESTING SERVICES

The tests are carried out as per the relevant national and international standards

* National Accreditation Board for testing and calibration Laboratories

2 TRI AS2

MICROBIOLOGY TESTING SERVICES

INTERNATIONAL

STANDARD

DESCRIPTION

INFERENCETYPE OF SAMPLE

SAMPLE SIZE (m)

TAT(Days)

AATCC 147

To determine antibacterial activity of diffusible antimicrobial agents on treated textile materials.

Zone of Inhibition

Fabric 0.5 5

JIS L 1902 :

2008

To evaluate the antibacterial efficacy of antibacterial finished textile products

Zone of Inhibition

Fabric 0.5 5

AATCC 174

Part 1

To determine the antimicrobial activity of new

carpet materials and the effect of a cleaning process on the antimicrobial resistance of carpets.

Zone of Inhibition

Fabric(Carpets)

0.5 5

EN ISO 20645 : 2004

To determine the effect of antibacterial treatments applied to woven, knitted and other flat textiles.

Zone of Inhibition

Fabric 0.5 5

INTERNATIONAL STANDARD

DESCRIPTION

INFERENCE

SAMPLE TYPE

SAMPLE SIZE(m / g*)

TAT(Days)

AATCC 100

To evaluation the degree of antibacterial finishes on textile materials.

Percentage reduction

Fabric

1 10

JIS L 1902 :

2008

To evaluate the antibacterial efficacy of antibacterial finished textile products

Log reduction

Fabric

1 10

AATCC 174

Part 2

To determine the antimicrobial activity of new carpet materials and the effect of a cleaning process on the antimicrobial resistance of carpets.


Fabric

(Carpets)

1 7

*ASTM E - 2149

To evaluate the antimicrobial activity of non-leaching antimicrobial treated specimen under dynamic contact conditions.


Fabric, Fiber, Yarn, Powder, Plastic, Metals

10 g 5

ASTM E 2180-07

To evaluate the antimicrobial effectiveness of agents incorporated or bound into or onto mainly flat hydrophobic or polymeric surfaces.


Fabric 1 10


DESCRIPTION INFERENCE SAMPLE TYPESAMPLE SIZE (m)

TAT(Days)

AATCC 30 Part 1 To determine the degradability of textile materials.

Degradable / Non -Degradable

Fabric 0.5 160

AATCC 30 Part 3To evaluate the susceptibility of textile specimen against fungal sp like Aspergillus niger.

Zone of inhibition

Fabric 0.5 25

AATCC 174 Part 3To determine the antimicrobial activity of new carpet materials and the effect of a cleaning process on antimicrobial resistance of carpets.

Zone ofinhibition

Fabric(Carpets)

0.5 25

Antifungal Evaluation (Quantitative)


DESCRIPTION INFERENCE SAMPLE TYPE

SAMPLE SIZE (m)

TAT(Days)

ISO 13629 –Part 2

To determine the antifungal activity of textile products using plate count method.

Percentage reduction Fabric 1 25

STANDARDMETHODS

DESCRIPTION INFERENCESAMPLE

TYPESAMPLE

SIZETAT

(Days)

Kirby Bauer Method

To determine the sensitivity or resistance of pathogenic aerobic and facultative anaerobic bacteria to various antimicrobial compound impregnated textile materials in order to identify its effectiveness against test organisms.

Zone of inhibition

Powder, Liquid, disc, and fabric.

1mg50 µl,5 mm

/

5

MinimumInhibitory

Concentration (MIC)

To determine the minimum inhibitory concentration (lowest concentration) of an antimicrobial compound that will inhibit thevisible growth of a microorganism at appropriate incubation conditions.

Lowest concentration of drug which inhibit growth of organism.

Powder,Liquid.fabric

1 g5 ml,1 cm

5

Antifungal Evaluation (Qualitative)

Antibacterial Evaluation (Quantitative)

Antibacterial Evaluation (Qualitative)

Antimicrobial susceptibility test

4TRI AS

MICROBIOLOGY TESTING SERVICES

Water Testing


DESCRIPTION

INFERENCESAMPLE

TYPESAMPLE SIZE (mL)

TAT(Days)

IS 5401 -

Part 1

Enumeration of coliforms-

colony count technique

Enumeration of coliforms present in products intended for human consumption by means of colony count technique.

CFU / mL Liquid 100 5

APHA 9215 A,B

Total Bacterial Count

To estimate the number of live heterotrophic bacteria in water and measuring changes during water treatment and distribution.

CFU / mLLiquid

100 5

APHA 9215 C

Total Fungal Count

To estimate the number of fungus in water and measuring changes during water treatment and distribution.

CFU / mLLiquid

100 15

IS 1622-1981

MPN (Most Probable Number) Technique

To measure the bacterial density which is most likely to be present in water.

MPN Index / 100 ml

Liquid500 5

IS 1622-1981Methods of Sampling and Microbiological

Examination of Water

To measure the viable aerobic and facultative anaerobic bacteria in water through selective medium.

CFU / mLLiquid

500 5

Sterility evaluation


DESCRIPTION

INFERENCE

SAMPLE

TYPE

SAMPLE SIZE(Cm)

TAT(Days)

Steam Sterilization -

Autoclave

Autoclave is an instrument

that uses

steam

to

sterilize

equipment and other objects by subjecting them to high pressure saturated steam at 121

°C for 15 to 20 min.

Colour change in chemical indicator andcompletion of sterilization

Fabric, Fibre, Yarn and heat

resistant material.

100 x 10 2

Gas Sterilization -

(EtO)

Ethylene Oxide (EtO) sterilization is mainly used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam sterilization.

Completion of sterilization

Fabric, Fibre, Yarn and heat

labile material.

100 x 10 2

ISO 11737 – Part 1Bioburden Testing

Sterilization of medical devices -Determination of a population of microorganisms on products

CFU / mL

Fabric, Fibre,

Fabric, Fibre,

Yarn

Yarn

Plastic &

Plastic &

Metals.

Metals.

Tube – 20 cm,Plastic – 2 x 2 cm,

Fabric – 10 x 10 cm25

ISO 11737 – Part 2Sterility Testing

Sterilization of medical devices -Validation and maintenance of a sterilization process

CFU / mLTube – 20 cm,

Plastic – 2 x 2 cm,Fabric – 10 x 10 cm

25

4

Other tests

STANDARDMETHODS

DESCRIPTION INFERENCESAMPLE

TYPESAMPLE SIZE

(Cm)TAT

(Days)

Wet PenetrationTo evaluate the bacterial penetration resistance characteristics of protective materials.

Pass / FailFabric, Film

& Plastics5 x 5 3

Bacterial adhesiontest

To find the bacterial adhesion property of the sample which allows bacteria to attach or adhere surface.

Bacterial adherence

images

Fabric, Metal & Plastics

1 x 1 5


DESCRIPTION

INFERENCESAMPLE

TYPESAMPLE

SIZETAT

ASTM F 1671 –

07

(Viral Penetration Resistance Test)

To measure the resistance of materials used in protective clothing to penetration by blood borne pathogens using a surrogate microbe under

conditions of continuous liquid contact.

Pass / FailFabric

(Surgical gowns)

1 m10

days

ASTM F 2101

(Bacterial Filtration

Efficiency)

Evaluation of the Bacterial filtration efficiency (BFE) of medical textiles using Staphylococcus aureus aschallenging aerosol.

Filtration Efficiency

Fabric(Face Mask)

10 no.5

days

ASTM F 2101

( Modified)(Viral Filtration

Efficiency)

Evaluation of the Viral filtration

efficiency (BFE) of medical textiles using Bacteriophage Phi X 174 as challenging aerosol.

Filtration Efficiency

Fabric 10 no 20

Personal Protective Equipment

TRI AS

BIOTECHNOLOGY TESTING SERVICES

5

BIOLOGICALTESTING

CytotoxityISO

10993:5

skinirritation

ISO 10993:10

Tumor spheriod

Apoptosis/Necrosis

Healing woundactivity In vitro

model

Antioxidants

Anticanceractivity

Biocompatibility testing

S. No

International

standards Testing

Description

Sample

requirement

TAT

1

ISO 10993 : 5

Cytotoxicity

Direct

& Extraction

Quantifies the no. of viable cells based on their mitochondrial metabolic activity against MTT

10mg

10 ml

15

Indirect

2

ISO 10993 : 10 In vitro

skin

irritation Determines the effect of lecahate /

chemicals on skin cells 1gm

10ml

90

Evaluates the effect of toxic substance of textiles/device on the morphology of normal cells.

Solid Liquid(Days)

TRI AS6

Anti-cancer activity Preliminary studies of evaluating the whole cellular cytotoxic effect of test materials.


TEST METHODS DESCRIPTION INFERENCE

SAMPLE SIZE

TAT

(days) Solid

(textiles/ devices)

Powder

Minimum (mg)

Liquid

(ml)

Trypan blue- live /

dead cell assay

Differentiate live cells from dead cells based on the staining of trypan blue on the intact cell membrane / nucleus.

Cell count ; phase contrast

microscopy images

60 cm2

10

10

10

Cytotoxicity (indirect)

It evaluates the toxic effect of substance on the cellular morphology.

Effect of extract on cell morphology phase contrastmicroscopy images

60 cm2

NA NA 18

Cytotoxicity

(direct – MTT assay)

Quantifies the no. of viable cells based on mitochondrial metabolic activity against MTT.

IC

50 value;

morphological changes – phase

contrast microscopy

60 cm2

10 10 15

Neutral Red uptake assay

Quantifies viable cells based on their ability to incorporate and bind the supra vital dye neutral red in lysosome.

IC value; morphological

changes – phase contrast

microscopy

60 cm2

10 10 15

Nitric oxide assay

Determine the nitriteradical mediated

cellular death (Apoptosis).

IC50

value; morphological

changes – phase contrast

microscopy

60 cm2

10 10 15

Cell adhesion study /sample

-

Cell attachment / growth on test material using

FeSEM

60 cm2

NA NA 20

50

Tumor Spheriod formation (3D)

model

An in vitro model used for cancer research studiesIt mimics the in vivo tumor condition.

Reduction in the size of tumor spheroid / cells

viability.

NA 1 2 25

Cell adhesion helps to study the cellmatrix interaction in in vitro condition.

TRI AS

Dysregulation of the apoptotic pathway can contribute to the pathology of many diseases.

APOPTOSIS / NECROSIS

7


TEST NAME DESCRIPTION INFERENCE

SAMPLE SIZE

TAT

(days)

Solid

(textiles/

devices)

Powder

minimum

(grams)

Liquid

(ml)

Lactate dehydrogenase

assay

It measures the membrane integrity of cancer / normal cells

after treatment.

IC50

value,

Measurement of LDH leakage in the supernantant.

60 cm2

1 2 15

Apoptosis using fluorescent dyes

To study/ differentiatethe extra & intracellularchanges in normal/cancer cells aftertreatment.

Mode of cell death; morphological

changes through inverted phase

contrast microscope images.

60 cm2

1 2 15

Annexin V –

Cy3TM

apoptosis

Early Apoptosis / Necrosis

morphological changes through inverted phase

contrast microscope images.

0

DNA fragmentation

Apoptosis inducing ability of drugs on cancer

cells.

Observation of

fragmented DNA on agarose gel.

NA 1 2 20

60 cm2 1 2 1

TRI AS8

TEST NAME INFERENCE

Sample TAT

(days)

Solid (grams)

Liquid (ml)

Enzymatic activity

Total Antioxidant Capacity

Level of enzymatic activity

will be determined

1 20 10

Catalase Activity 1 20 10

SOD Activity 1 20 10

GST activity 1 20 10

GPX assay 1 20 10

Non enzymatic activity

DPPH assay Level of non-

enzymatic activity will be

determined

1 20 10

Ascorbic acid 1 20 10

ABTS assay 1 20 10

Glutathione & â - carotene 1 20 10

ANTIOXIDANT ASSAY

Measurement of enzymatic and non enzymatic activity of cells, describes the effectiveness of the test substance in protecting human from the harmful effects of free radicals

Wound Scratch AssayIn vitro scratch assay is performed to confirm the healing activity before

going in for animal model. It is suitable for the studies on the cell-cell and cell-matrix interaction.

TEST NAME DESCRIPTION SAMPLE

REQUIRED TAT

(days)

Scratch wound model (2D) Wound healing profile at different

time intervals 1gms/ 10ml

10

Scratch wound model (3D)

ØGas chromatography- Mass SpectrometryMass SpectrometryHPLCHPTLC

ØØØ

0th hr 18th hr 24th hr

Healing pattern of L929 mouse fibroblast cell line in different time periods

ØAASØFT-IRØInductively coupled plasma mass spectrometry (ICP-MS)ØScanning Electron Microscopy (Fe-SEM)

Extracts/Materials characterization


TRI AS9

LIST OF CELL LINES AVAILABLE IN OUR LABORATORY

Normal cells

L929 cell

Cervical cancer cells

HeLa cell

Breast cancer cells

MCF-7, MB 231 cells

Osteoblast cells

MG-63 cell

Hepatocellular cells

Hep G2, Hep 3B cells

Skin Malignant melanoma

A375 cell

Depending upon the requirement, the center can help in growing specific cell lines

of customers’ interest for various other applications

Overall view of Medical devices/textiles and their biocompatibility evaluation

Device Categories Examples Contact

duration

Test parameters

Cytotoxicity Irritation

Surface devices

Skin

Medical textiles/Devices that contact intact skin

surfaces only. Eg : Bandages, fixation

tapes & electrodes

A ? ?

B ?

?

C ?

?

Mucosal

membrane

Devices communicating with intact mucosal membranes.

Eg: contact lenses, urinary catheters, intravaginal and intraintestinal devices

dental prostheses & orthodontic devices

A

?

?

B

? ?

C ?

?

Breached or

compromised

surfaces

Medical textiles/Devices that contact breached or otherwise compromised external body surfaces.

Examples: tissue dressings or healing devices & occlusive patches.

A

?

?

B ?

?

C

?

?

External

Communicating

Device

Tissue/bone

/dentin

communicating

Medical textiles/Devices communicating with tissue, bone, and pulp/dentin system.

Eg: Surgical gown, mask, bandage &

extracorporeal devices.

A

?

?

B

?

?

C

?

?

Circulating blood

Textile/Devices that contact circulating blood.

Eg :

Scaffold material & extracorporeal

membrane/ devices.

A

?

?

B

?

?

C

?

?

Implant Device

Tissue/bone

Textiles/Devices principally contacting bone and

tissue.

Eg : scaffold material for bone & tissue regeneration

A

?

?

B

?

?

C

?

?

Blood Textiles/Devices principally contacting Blood.

Eg :artificial vascular graft, heat patch & sutures

A

?

?

B ? ?

C ? ?

Evaluation by ISO method A – Limited exposure (≤ 24hrs) B – Prolonged exposure (>24 hrs to ≤30 days) C – Permanent exposure (>30 days)


TRI AS10

Field Emission Scanning Electron Microscope Facility

FeSEM plays an important role in research and development of advanced materials in many technologies. To meet the increased demand for analytical, high resolution imaging of the numerous clients and research scholars, SITRA's CoE-Medical Textiles has recently been installed with high end Fe-SEM from Carl Zeiss, UK. The instrument has the following features.

oResolve structures that are as small as 1.5 nm.

oDifferent detectors to analyze surface structure,topography and elements.

oAdvanced signal detection system includes highly efficient Everhart-Thornly secondary electron detector for high resolution imaging.

oFe-SEM with energy dispersive X-ray (EDX) spectroscopy for the elemental analysis.

oAdvanced variable pressure mode and Turbo molecular-pumped coating system to image non-conducting samples.

oMagnification range: up to 1 million times.

S.NO. SAMPLE TYPE QUANTITY

1 Textiles sample 5x5 cm

2 Powder Sample 20 mg

3 Biological Sample : Bacterial

culture

Minimum organism

1 x 105

CFU/ml

4 Cell adhesion on film 2x2 cm

5 Metal 1x1 cm

6 Dental sample 1x1 cm

TRI AS11

SAMPLE IMAGES OF SITRA'S FE-SEM FACILITY

Bone implant

Bacteria

Non-woven

Surface of Plant leaf

Worm

Fiber - Longitudinal

Vascular bundles

Cell growth on bone implants

Dental

Nanomembrane Cotton Convolution

TRI AS12

Email: [email protected]; [email protected]; Tel: 0422-4215333 ext: 323; 373.

CoE Biotechnology Divison,

The South India Textile Research Association (SITRA)13/37, Avinashi Road, Aerodrome PostCoimbatore - 641014, IndiaPhone: 0422-4215333 Extn: 364/365Fax No: 0422 2571896, 4215300

Details about CoE Meditech:Head I/C, [email protected],in; [email protected]:www.sitra.org.in; www.sitrameditech.org.in

TESTING SERVICES OFFERED FOR

TRI AS

MEDICAL TEXTILES PRODUCTS

HERBALS

TEXTILES PHARMACEUTICAL

LEATHER

LIQUIDS COSMETICS

METAL

For details, please contact:

SITRA BIOLOGICAL TESTING SERVICES

CoE-Medical Textiles in addition to Biological testing also provides consultancy to academic/industry projects. Short term project of academics (Bachelors, Masters, M.Phil, Ph.D, MBBS & M.D) in the field of Life sciences, Textile Technology, Medicine, Paramedical, etc., are undertaken. Based on the requirement, we help in preparing manuscript for the work done at the centre.


Coimbatore- 641014

TRI AS

SITRA - COE MEDICAL TEXTILEPHYSICAL LABORATORY TESTING SERVICES

SITRA - COE MEDICAL TEXTILEPHYSICAL LABORATORY TESTING SERVICES

TRI AS2

About Us

PHYSICAL LABORATORY TESTING SERVICES

Medical Textiles

Technical textiles is one of the fastest growing sectors of the global textile industry. The world textile industry is moving rapidly towards manufacturing high-added value textile structures. Medical textile is an emerging sector of technical textiles industry and its growth is fuelled due to constant improvements in healthcare as well as innovations in the textile field. The textile materials have generated considerable interest in medical technology where textile materials in the form of fibre, yarn, fabric (woven, non woven, knitted) and garments are being used for medical applications. The use of textile materials for medical and healthcare products ranges from simple gauze/bandage materials to scaffolds for tissue culturing and a large variety of prostheses for permanent body implants.

The Ministry of Textiles, Government of India has identified SITRA as a nodal centre in India for Medical Textiles and designated with Centre of Excellence (COE) for Medical Textiles. In the area of quality evaluation, SITRA CoE Physical laboratory is equipped with several high technology instruments and providing testing facilities as per International Standards like ASTM, ISO, BIS, BS EN, etc. for different products of Medical Textiles

SITRA CoE Physical laboratory is certified with ISO/IEC 17025:2005 certification from NABL and the testing services is in accordance with global regulatory guidelines. SITRA’s quality of services has reputation from National and International Institutions.

We stand For

3 TRI AS


Surgical Gown/Surgical Drape

Surgical Face Mask

AAMI PB70 Tests EN 13795 Tests

Hydrostatic resistance AATCC 127

Synthetic blood penetration resistance

ASTM F 1670

Test Parameter International

Standards

Water impact penetration test AATCC 42


Standards

Hydrostatic resistance EN 20811

Bursting strength EN ISO 13938 -1

Linting EN ISO 9073 -10

Cleanliness particulate

Matter EN ISO 9073 -10

Tensile strength EN 29073 -3


Standards

Splash resistance ASTM F 1862

Breathing resistance MIL-M-36954C

EN 14683 ASTM F 2100


Standards

Splash resistance ASTM F 1862

Breathing resistance MIL-M-36954C

Particle filtration efficiency ASTM F 2299

TRI AS4


HYGIENE MEDICAL TEXTILE PRODUCTS(Baby Diaper, Sanitary Napkin, Adult Incontinence diaper, Under Pad)

Sanitary Napkin – IS 5405 Package Test

Test parameters International Standards

Liquid strike through time EDANA 150.5 & ISO 9073-8

Repeated liquid strike through time WSP 70.7 & ISO 9073-14

Wet back EDANA 151.2& ISO 9073-13

Wetback after repeated strike through time WSP 70.8 & ISO 9073-14

Run-off WSP 80.9 , ERT 152.2 & ISO 9073-11

Free swell absorptive capacity ERT 440.2 & ISO 17190-5

pH WSP 200.2, ERT 400.2 & ISO 17190-1

Fluid retention capacity after centrifugation WSP 241.3, ERT 441.2 & ISO 17190 - 7

Liquid transport characteristics AATCC - 195

Test Parameters International

Standards

Length & width

IS 5405

Thickness

Absorbency

pH

Disposability


TRI AS5

Gauze /Swab/Laparaotomy sponge/ Bandage Roll

Gauze /Swab/Laparaotomy sponge/ Bandage Roll

Test Parameter International Standard

Weight per square metre g/m2 IS 15891:Part 1

Absorption: IS 15891:Part 6

Water holding capacity, percent, min

Tensile strength in machine direction

(Dry) in N/5 cm, Min IS 15891:Part 3

Tensile strength in machine direction

(wet) in N/5 cm, MinIS 15891:Part 3

Test parametersInternational

Standards

Loss on drying British pharmacopeia

Foreign fibres -

Neps AFIS

Absorbency IS 14944

Water Holding capacity IS 14944


TRI AS6

Compression stockings/Arm sleeves

Crepe Bandages

Test Parameters International

Standards

Compression level in mmHg IS 16467

Extensibility IS 14944

Test parameters International Standards

Dimension IS 4605

Stretchability IS 4605

Elastic recovery IS 4605

Breaking load IS 1969


TRI AS7

Orthopaedic Stockinet

Plaster of Paris Bandage

Test ParametersInternational

Standards

Weight / unit area of Single Unstretched layer IS 16303

% Stretch in Cross Direction IS 16303

% Region in stretched layer in Cross Direction IS 16303

Breaking Strength IS 16303

Elongation at break IS 16303

Test parametersInternational

Standards

Saturation time IS 4738

Setting time IS 4738

Cast breaking strength IS 4738

The South India Textile Research Association 13/37, Avinashi Road, Aerodrome PostCoimbatore - 641014, IndiaPhone: 0422-4215333 Extn: 349Fax No: 0422 2571896, 4215300Email: [email protected]

CoE Medical Textiles Physical Testing Division,

For more details, please contact:



Coimbatore- 641014

TRI AS

SITRA - COE MEDICAL TEXTILEPOLYMER LABORATORY TESTING SERVICES

SITRA - COE MEDICAL TEXTILEPOLYMER LABORATORY TESTING SERVICES

TRI AS2

POLYMER LABORATORY TESTING SERVICES

Polymer synthesis provides a leading role in innovative polymers. The lab is based within the Center of Excellence for Medical Textiles, with state-of-the-art testing facilities. Synthesis of well-defined homopolymers and copolymers with complex macromolecular architecture by using combinations of all available polymerization methodologies (ionic, ATRP, RAFT, polyhomologation, catalytic, ROMP, etc) and molecular/structural characterization, modification of natural polymers by synthetic method, surface modification of natural and synthetic polymers for medical application and hydrophilic & hydrophobic functionalized gels for wound care materials are carried out.

FACILITIES

ELECTROSPINNING

The electrospinning unit is used to produce nano fibers for all the

technical textiles applications of

DIELECTRIC CONSTANT MEASUREMENT

Dielectric Constant measurement is used to know the capacitance and insulation properties of

materials

FOUR-PROBE CONDUCTIVITY MEASUREMENT

Four-probe conductivity measurement is used to analyze the conductivity of solid materials with nano-meter thick films in different temperature

conditions.

TRI AS

POLYMER LABORATORY TESTING SERVICES

3

The Polymer laboratory is a fully equipped laboratory in SITRA performing routine and unusual chemical tests on medical textiles and related products in all forms. The majority of the tests are performed in strict accordance with the international standards. In addition, our experts are highly talented in the interpretation of test results.

Medical Textiles Chemical & Polymer Testing offered

S S. .No. No.Test TestName NameStandard Standard

1 pH IS

2 Water soluble substances British pharmacopeia

3 Solvent soluble substances British pharmacopeia

4 Fiber Identification AATCC

5 Ash value British pharmacopeia

6 Fluorescence In-House

7 Acidity & Alkalinity BIS

8 Surface active substance BIS

9 Starch & Dextrin BIS

10 Sulphated ash British pharmacopeia

11 Drying loss BIS

12 Moisture content British pharmacopeia

13 Calcium Sulphate IS

14 Content of nitrofurazone In-House

15 Determination of proofing content IS

16 Electrospinning In-House

17 FTIR In-House

18 Fe-SEM In-House

19 Elemental analysis using Fe-SEM In-House

20 Four prob conductivity In-House

21 Thin layer chromatography In-House

Solution Conductivity measurement temperature sensors are used to analyze the conductivity of a soluble (solutions) substance in different concentration under different temperature conditions.

SOLUTION CONDUCTIVITY METER

pH METERpH Meter measurement with temperature sensors is used to analyze the pH of a solution with variable temperature.

VACUUM OVEN

Vacuum oven used to dry a substance under reduced pressure.

HOT-AIR OVEN

Hot-Air oven to dry a substance under controlled temperature under atmospheric pressure.

ULTRASONICATOR

Ultrasonicator used to make a dissolution and solubilization of desired materials.

DOUBLE DISTILLATION UNIT

Double Distillation unit is used to prepare a high pure double distilled water for research and analysis applications.

Technical Service Our team members are experienced in multidisciplinary problem solving.

We offer consulting services from deep to short discussions, problem solving and advising to costumers.

Method developmentDevelop new methods for emerging needs and samples based on

customers’ needs.

Project & TrainingThe laboratory provides solutions to academic institutions as well as

industries. Final year project works for masters short term (3 months & 6 months), one year M.Phil. projects and long term doctorate (Ph.D.) level guidance are offered with the affiliation of Bharathiyar University and

Anna University.

The South India Textile Research Association (SITRA)13/37, Avinashi Road, Aerodrome PostCoimbatore - 641014, IndiaPhone: 0422-4215333 Extn: 336, 364Fax No: 0422 2571896, 4215300Email: [email protected]

CoE Medical Textiles Polymer Testing Division,




Coimbatore- 641014

TRI AS

SITRA - COE MEDICAL TEXTILETesting Facility for

Personal Protective Equipment (PPE)

SITRA - COE MEDICAL TEXTILETesting Facility for

Personal Protective Equipment (PPE)

TRI AS2

Testing Facility for Personal Protective Equipment

Personal Protective Equipment - Protection against biological hazards

Personal Protective Equipment (PPE) is defined as “any device to be worn or held by the users for protection against one or more health and safety hazards”. These hazards may result from contact with chemical, biological, radiological, physical, electrical, mechanical agents and other workplace hazards. With regards biological hazards in professional situations, eg, Microbiology, Biotechnology laboratories etc, the risk of exposure is limited to the occurrence of an accident as the infectious agents can be controlled, and the organisms to which the workers may expose are usually well defined. But, in other type of works, eg. Health care, sewage works, waste treatment sites, etc, the infectious agents cannot be controlled and the workers are continuously exposed to the unknown infectious agents. Protective suits, gloves and masks are therefore lifesaving against these infectious agents. It is necessary to be design and construct these equipment in a safe manner and maintain them in a clean and reliable fashion. Any construction or design failures of PPE, can leave the users exposed dangerously to hazards. Various international standards determine the performance requirements and test methods for PPE against infectious agents. These equipment must prevent infectious agents from coming into contact with the user’s skin.

SITRA’s biological testing laboratory, in addition to the microbiological and biotechnological testing facilities are upgraded with PPE testing facility. The following instruments have been fabricated according to international standards and having the capabilities to test PPEs which are used to protect users from biological hazards.

• Bacterial Filtration Efficiency (BFE) Tester – ASTM F 2101-07• Synthetic Blood Penetration Resistance Tester (SBPRT) – ASTM F 1671-07• Dry Microbial Penetration Resistance Tester (DMPRT) – ISO 22612:2005• Wet Bacterial Penetration Resistance Tester (WBPRT) – ISO 22610:2006

Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus (ASTM F 2101-07 )

Test materials

Sample size:

Workers, primarily those in the health care profession involved in treating and caring for individuals injured or sick, as well as the patients, can be exposed to biological aerosols capable of transmitting diseases. These diseases, which may be caused by a variety of microorganisms, can pose significant risks to life and health. This test instrument helps to assess the effectiveness of materials used in protective clothing for protecting the wearer against biological aerosol developed using S. aureus (ATCC 6538).

Medical face masks

6 test specimens of 110 mm (area)

Figure 1. Bacterial filtration efficiency testing instrument

TRI AS


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Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System (ASTM F 1671-07 )

Test materials

Sample size:

Workers, primarily those in the health care profession involved in treating and caring for individuals injured or sick, can be exposed to biological liquids capable of transmitting disease. These diseases, which may be caused by a variety of microorganisms, can pose significant risks to life and health. This is especially true of blood-borne viruses which cause Hepatitis (HBV and HCV), AIDS (HIV). This test instrument helps to assess the effectiveness of materials used in protective clothing for protecting the wearer against contact with blood-borne pathogens using a surrogate microbe suspended in a body fluid simulated under conditions of continuous contact.

Protective clothing materials (gowns, drapes, gloves etc)

10 test specimens of 100 mm dimensions

Figure 2. Synthetic blood penetration resistance testing instrument

Clothing for Protection against infectious agents – Test method for resistance to dry microbial penetration (ISO 22612:2005 (E)

• The test method is designed to determine the ability of materials to resist penetration of particles carrying microorganisms under dry fabric conditions.

• The method establishes the quantity of microorganisms that can penetrate through the test material being carried on talcum powder.

• Test results are expressed in CFU (colony forming units) that are observed on the agar plate.

Sample size and test materials : 18 pieces of 200 mm x 200 mm sizes of surgical gowns, surgical drapes, clean air-suits and other clothing used to protect against infectious agents.

The apparatus supporting the containers is then vibrated by a pneumatic ball vibrator. The talc that penetrates is captured on the sedimentation plate. The sedimentation plates are removed and incubated. The numbers of colonies produced are counted.

Figure 3. Dry microbial penetration tester

TRI AS


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Performance requirement

Performance requirement

Surgical gowns Surgical drapesClean air suits

Unit Standard performance High performance Standard performance High performance Requirement*

Critical area

Less critical area

Critical area

Less critical area

Critical area

Less critical area

Critical area

Less critical area

Log 10 (CFU)

N/A ≤ 2 a,c N/A ≤ 2 a,c N/A ≤ 2 a,c N/A ≤ 2 a,c ≤ 2 a,c

a Test conditions: challenge concentration 102 CFU/g talc. And 30 mins vibration time. c For the purpose of this standard, log10 CFU

≤ 2 means maximum 300 CFU.* Performance requirements apply for all product areas of clean air suits, as clean air suits should be used in addition to surigcal gowns and not as a substitute.

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)

• It evaluates the ability of fabrics to resist microbial penetration under conditions of liquid pooling on the fabric and mechanical stress.

• Test results are expressed in BI “Barrier Index”.

: 10 test specimens of 25 cm x 25 cm of surgical gowns, surgical drapes, clean air-suits and other equipments used to protect against infectious agents.Sample size and test materials

Figure 4. Wet bacterial penetration tester

Surgical gowns Surgical drapesClean air suits

Unit Standard performance High performance Standard performance High performanceRequirement*

Critical area

Less critical area

Critical area

Less critical area

Critical area

Less critical area

Critical area

Less critical area

BI ≥ 2,8b N/A 6,0b,d N/A ≥ 2,8b N/A 6,0b,d N/A N/A

b The Least Significance Difference (LSD) for BI when estimated using EN ISO 22610, was found to be 0,98 at the 95 % confidence level. This is the minimum difference needed to distinguish between two materials thought to be different. This means materials varying by up to 0,98 BI are probably not different; materials varying by more than 0,98 BI probably are different (The 95 % confidence level means that an observer would ne correct 19 times out of 20 to accept these alternatives).

d BI = 6,0 for the purpose of this standard means : no penetration. BI = 6,0 is the maximum achievable value.


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Coimbatore - 641014, IndiaPhone: 0422-4215333, Extn.: 364/365

Fax No: 0422 2571896, 4215300Email: [email protected],in; [email protected]

Website:www.sitra.org.in; www.sitrameditech.org.in

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