The Biomedical Technology Wing of the Institute, located at Poojapura Campus offers selected testing services to external customers - primarily intended for the medical device industry in the areas of Physico-chemical characterization as well as biological evaluation of materials. The testing services are coordinated by the Customer Service Cell (CSC), which is the point of all contact and communication for the external customers with the Institute.

The CSC will extend you with all support such as providing information on the testing services, testing timelines, limitations, test methods, test charges, payments etc. If required, interaction with testing laboratory will be facilitated by the CSC. Please feel free to contact the CSC for all your queries regarding testing services.

An Overview of the Testing Services offered:

Click here for the List of equipments available at Central Analytical Facility

1. Characterization of materials as per international standards using analytical techniques:

2. Biological Evaluation meeting the requirements of International standards ISO 10993, ASTM & USP:

3. Preclinical Functional and Safety Evaluation of Medical Devices

Preclinical studies: Safety and functional performance evaluations in large animals are also offered as part of the testing service and the Institute possess excellent facility and expertise for the evaluation. These studies are carried out on a study mode based on a study plan/protocol which is prepared based on the requirement of the customer. Budget for the study is made and is to be paid by the sponsor. These animal studies are conducted subject to approval by the CPCSEA.

Preclinical Large Animal Evaluation

Animals provide a valuable testing system anatomically, physiologically or even pathologically because of their phylogenetic closeness to humans. Preclinical large animal evaluation is generally conducted in order to provide a reasonable assurance of device safety prior to use in humans in a clinical trial. Relevant animal models are selected depending on the clinical application of the device.

Experience & expertise in the evaluation of critical cardiovascular & neurosurgical products and sophisticated facilities is a good advantage to us.

Expertise include evaluation of majority of the cardiovascular devices like drug eluting coronary stents, heart valve etc.

Accelerated Ageing Studies

The manufacturer must ensure the product and package system combine to create a total product that performs efficiently, safely and effectively in the hands of the user.

Accelerated aging is the storing of packages at elevated temperature and / or other intensified environmental conditions in order to simulate real time aging in a smaller duration of time. Environmental chambers are used for accelerated aging test.

The principle behind the concept of accelerated ageing is that the ageing of medical device packaging can be accelerated to two time space by increasing the storage temperature by 10oC, by what is known as Q10 analysis.

The ageing studies are carried out on the basis of the following:

• Donald S Barcan and Harold F Miller, Package Validation in Max Sherman (Ed.), Medical Device Packaging Handbook, Marcel Dekker Inc, NY, 1998, pp267-30
• The European Agency for the Evaluation of Medicinal Products. Guideline for stability testing : stability testing of existing active substances and related finished products, CPMP/QWP/122/02 rev 01 , Dec 2003

The BMT Wing is well equipped with advanced facilities such as:

Equipments

Imaging - Scanning electron microscope, transmission electron microscope, confocal microscope, micro CT

Material characterization - FT Raman spectroscopy, FTIR spectroscopy,UV Vis spectroscopy, HPLC, Thermal Analysers ,Dynamic mechanical analysers, UTM, Vickers hardness, profilometer

Histopathology - Smart tissue processor, robotic cover slipper & auto strainer, rotary microtome, saw microtome, tissue embedder

Large animal facility

Fully equipped OT for large animal surgeries including open heart surgery, Cardiac catheterization, Interventional radiology, Transthoracic and TE Echocardiography, AD Instruments Powerlab 4/30 for acquiring physiological pressure and electrical events, Clinical laboratory for blood gas analysis, coagulation analysis, serum biochemistry and hematology, Sterilization (steam/ETO/chemical), Post-operative acute care for large animals, Experimental large animal (pig, goat, dog) breeding/ holding.

Small animal facility

Housing of small animals like rabbit, rat, mice, guinea pigs. The care and management of animals is as per ISO 10993- Part-II guidelines on an International platform and under CPCSEA guidelines on the National platform. There are separate facilities for breeding and nursery.

What Every Test Request Should Have

Test request forms (unique for each test) and the client detail form (kindly mail us at for requesting the forms)

Material Safety Data Sheet (MSDS) and the certificate from the Head of the Institution in case of FT Raman and FTIR (Format is available with us - Kindly request from )

Dos

Do Nots

Our Quality management system for testing services confirms to the international standard ISO/IEC 17025: "General requirements for the competence of testing and calibration laboratories".

About twenty biological tests which includes biocompatibility testing also are accredited by Le Comite Francais d'Acreditation (COFRAC) of France. The test reports of all accredited tests are issued with the COFRAC logo. Click here to view the scope of accreditation.

Calibration services (mechanical and thermal calibration) is accredited by National Accreditation Board for Testing & Calibration Laboratories (NABL).

Biocompatibility testing and evaluation of medical devices is performed to determine the potential toxicity resulting from contact of the device with the body. The device materials should not-either directly or through the release of their material constituents-produce adverse local or systemic effects, be carcinogenic, or produce adverse reproductive and developmental effects. The biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation programme within a risk management process in accordance with ISO 14971 as set out in the figur

As per ISO 10993 the choice of tests and the data required in a biological evaluation and their interpretation shall take into account the chemical composition of the materials, including the conditions of exposure as well as the nature, degree, frequency and duration of exposure of the medical device or its constituents to the body, enabling the categorization of devices to facilitate the selection of appropriate tests.

The biological evaluation performed based on ISO 10993 categorizes medical devices according to:

1. MATERIAL CHARACTERIZATION

Material characterization is the crucial first step in the biological evaluation process. The extend of chemical characterization depends on what pre-clinical and clinical safety and toxicological data exist, and on the nature and duration of body contact with the medical device, but as a minimum the characterization shall address the constituent chemicals of the device and constituent residual process aids or additives used in its manufacture.

The following material characterization facilities are available :

2. BIOLOGICAL TESTS

Other tests offered includes

This guideline is prepared to help you understand the importance of proper "sample preparation" for the different tests performed for the biological evaluation of materials.

It must be noted that testing is to be performed on the final product, or on representative samples taken from the final product or from materials processed in the same manner as the final product.

Submitting proper samples will go a long way in ensuring that you get the proper test reports in time.

We strongly advise you to visit us and discuss your testing requirements and get first hand information on the sample requirements for the selected tests; especially if you plan to submit the test reports to any regulatory agency.

GENERAL INFORMATION:

We conduct tests on the samples submitted by you and the test results provide results for the test samples only. We do not certify your batch or product quality.

Our test reports will specify the test material/sample code as mentioned by you in the test request forms. Kindly ensure that you have specified the proper sample code that will reflect your end use. If you are submitting the test reports to a regulatory agency, ensure that the test sample codes will provide unambiguous traceability to your material/product. We will not accept requests for change of test sample codes or other details such as name of company etc. on the test report after testing.

General Guidelines:

Dos

1. Contact the lab and understand the specific requirements beforehand
2. Follow the specific instructions on each test request form
3. Submit samples in separately marked packets for different tests
4. When replicates are required, pack the samples in separate individual packets
5. Label the packets correctly
6. Indicate the sterilization status- whether sterile and method of sterilization
7. Indicate clearly, special storage conditions if any for your sample
8. Do indicate shelf life of samples when the sample is unstable or has a limited shelf life only
9. Do submit appropriate CONTROL samples, if required as part of the study/test.
10. If test materials are to be archived then a special request need to be given. Test materials will be archived for a maximum of 3 years.

Don'ts

1. Do not submit samples with hazardous / infectious/ radioactive content.
2. Don't have sharp and pointed edges for your samples. Remove any burrs or sharp edges from the sample pieces.
3. Don't submit samples before prior intimation to the customer service cell, either by post or in person.
4. Don't mix samples for different tests together. Pack the samples for different tests separately.
5. Do not use staplers or pins on sterile packets. If sending by post/courier, ensure that there is no damage due to stapling by the courier agency.

Test Material Preparation

IN VITROCYTOTOXICITY (ISO 10993)

Direct / Indirect Contact

Shape and Size - Test material must have a flat surface & with one side having a surface area of approx 0.1 cm²/ 0.3cm²

OR

Test material with 4mm diameter disc

Quantity - 6 numbers of the material in any of the above specification - individually packed and in sterile form.

Test on Extract

Kindly specify the total surface area and weight of the sample in this case. Please stick on to any of the following specifications as per the thickness & nature of your test material.

IRRITATION /ACUTE SYSTEMIC TOXICITY/ GENOTOXICITY (ISO 10993)

What is the thickness (T) of your material?

Based on the thickness please select the option that suits your material from below

T<0.5 mm Film, sheet, tubing wall	T=0.5 to 1mm Tubing wall, slab, small moulded items	T >1 mm Large moulded items	T >1 mm Elastomeric closures	Irregularly shaped solid devices Powder, pellets, foam, nonabsorbent moulded items
• 20 strips with the below dimensions in one packet • Such 4 packets	• 20 strips with the below dimensions in one packet • Such 4 packets	• 20 strips with the below dimensions in one packet • Such 4 packets	• 5 strips with the below dimensions in one packet • Such 4 packets	• 2g in one packets • Such 8 packets

SENSITIZATION

What is the thickness (T) of your material?

Based on the thickness please select the option that suits your material from below

T<0.5 mm Film, sheet, tubing wall	T=0.5 to 1mm Tubing wall, slab, small moulded items	T >1 mm Large moulded items	T >1 mm Elastomeric closures	Irregularly shaped solid devices Powder, pellets, foam, nonabsorbent moulded items	T< 0.5 cm Materials to be tested without modification, Solid material
• 20 strips with the below dimensions in one packet • Such 22 packets	• 20 strips with the below dimensions in one packet • Such 22 packets	• 20 strips with the below dimensions in one packet • Such 22 packets	• 5 strips with the below dimensions in one packet • Such 22 packets	• 2g in one packets • Such 44 packets	• 10 strips with the below dimensions in one packet • Such 11 packets

PYROGEN

T<0.5 mm Film, sheet, tubing wall	T=0.5 to 1mm Tubing wall, slab, small moulded items	T >1 mm Large moulded items	T >1 mm Elastomeric closures	Irregularly shaped solid devices Powder, pellets, foam, nonabsorbent moulded items	Membranes Irregularly shaped porous devices
• 3 strips with the below dimensions in one packet • Such 20 packets	• 3 strips with the below dimensions in one packet • Such 20 packets	• 3 strips with the below dimensions in one packet • Such 20 packets	• 5 strips with the below dimensions in one packet • Such 22 packets	• 2g in one packets • Such 40 packets	• 2g in one packets • Such 20 packets

IMPLANTATION (ISO 10993)

Implantation in muscle	Implantation in subcutaneous tissue	Implantation in bone
1 mm width x 10mm length (rounded edges and the ends finished to full radius)	10mm to 12mm in diameter x 0.3mm to 1mm thickness OR 1.5mm diameter x 5mm length smooth radius ends OR	Cylindrical implants 2mm diameter X 6 mm in length OR 2mm to 4.5 mm orthopaedic bone screw type implants OR

HEMOLYTIC PROPERTY

Film, sheet, tubing wall	Powders / Irregular shaped Materials
• 10 strips with the below dimensions per packet • Such 6 packets AND • 7 strips with the below dimensions per packet • Such 6 packets	• 2g per packet • 6 packets AND • 1.4g per packet • 6 packets

Biomedical Technology Wing (BMT Wing) of Sree Chitra Tirunal Institute for Medical Sciences and Technology offers testing services to various categories of customers such as industries (especially in the medical device and health care field), researchers and students.

Please feel free to approach us at

Kindly write to us:

Kindly speak to us: +91-471-2520307/2520309

Kindly address all your postal correspondence to:

The Scientist In Charge,
Customer Service Cell,
BIOMEDICAL TECHNOLOGY WING,
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Poojappura, Thiruvananthapuram - 695012, INDIA

Feedback & Complaints

We take pleasure in getting the feedback of our customers to improve our system. Kindly send us your feedback to us through the feedback forms send to you.

Customers also free to make us aware of your complaints on our testing services.

WE VALUE YOUR FEEDBACK!

We have customers representing all parts of India and the following is a non-exhaustive list:

Anabond Stedman Pharma Research (P) Ltd, Chennai
Asha Biochem, Kerala
Aurolab, Madurai
Auxin Lifesciences, Gujarat
Axio Biosolutions , Bombay
Ayutec Systems, Bangalore
Beta Healthcare Ltd, Kerala
Biopore Surgicals, Mumbai
Biosync Scientific Pvt Ltd, Gujarat
Boston Scientific, Delhi
Dynamic Technomedicals, Kerala
Eastern Medikit, Haryana
Electro Medical & Allied Industries, Kolkata
Eon Meditek, Gujarat
Eucare Pharmaceuticals, Chennai
Fine Surgicals, Bangalore
Fresinus Kabi India pvt Ltd, Pune
Frontier Lifeline, Chennai
GE India Technology Pvt Ltd, Bangalore
Hankook Latex Pvt Ltd, Kerala
HD Medical Services (India) Pvt Ltd, Chennai
Hindustan Medical Devices, Faridabad
HLL Lifecare Ltd, Kerala
IFGL Refractories, Kolkatta
Jayon Implants, Kerala
JJ Orthodontics, Kerala
Larsen & Toubro Limited, Mysore
Meditek Devices, Mumbai
Meghdoot Pharma
Meril Lifesciences, Gujarat
NanoTherapeutics, Gujarat
Neptune Orthopaedics, Gujarat
Neuron Biomed equipments Pvt Ltd, Maharashtra
Nitta Gelatin, Kerala
N S Remedies,Kolkata
Orchid Pharmaceuticals,Tamilnadu
Penta Biovisions, Kerala
Polymedicure, Delhi
Reliance Life Sciences,Mumbai
Ribbel International, Delhi
Romsons Juniors India, Agra
Schiller Healthcare India Pvt Ltd, Pondicherry
Sericare, Bangalore
Sisco Medicals, Chennai
Splendour Medicare Technologies, Chennai
Sriram Meditek, Chennai
Sun Pharmaceuticals, Gujarat
Sutures India , Bangalore
Terumo Penpol Ltd, Kerala
TTK Healthcare India Ltd- Heart Valve division, Kerala
TTK Healthcare India Ltd - Ortho division, Chennai
Vedic Remedies, Bangalore
Wellset Plast Extrusion Ltd, Mumbai
Wellworth Polymers , Chennai

International Customers
Aortech Biomaterials , USA
Arrow International, USA
Embryon , Singapore
Graduate School of Biomedical Engineering (GSBME) University of New South Wales , Australia
Indus Medica LLC, US
Nanyang Technological University, Nanyang Avenue, Singapore.
Prosonic Co Ltd, Korea

• Mr. S. Balram
  Scientist 'G' (Senior Grade) & Scientist-in-Charge
  
• Ms. Sandhya C.G
  Engineer 'G'