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.

Percentage reduction

Fabric

(Carpets)

1 7

*ASTM E - 2149

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

Percentage reduction

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.

Percentage reduction

Fabric 1 10

INTERNATIONAL STANDARD

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)

INTERNATIONAL STANDARD

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

INTERNATIONAL STANDARD

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

INTERNATIONAL STANDARD

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

INTERNATIONAL STANDARD

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.

BIOTECHNOLOGY TESTING SERVICES

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

BIOTECHNOLOGY TESTING SERVICES

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

BIOTECHNOLOGY TESTING SERVICES

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)

BIOTECHNOLOGY TESTING SERVICES

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: coebio@sitra.org.in; se@sitra.org.in; 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, coemed@sitra.org,in; ssk@sitra.org.inWebsite: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.