Quality

Sree Chitra Tirunal Institute For Medical Sciences And Technology (SCTIMST)-Your Partner

For Testing And Bilogical Evaluation Of Medical Devices & Biomaterials

Services Offered for Biocompatibility Testing at SCTIMST

Cell Culure

In vitro cytotoxicity – direct contact, indirect contact, MTT assay (ISO 10993- 5)
Cell adhesion
Toxicology
Acute systemic toxicity (ISO 10993-10)
Irritation – intracutaneous, animal skin, penile, vaginal (ISO 10993-23)
Sensitization – maximization, closed patch (ISO 10993-10)
Hemoltyic property (ASTM – 756)
Implantation – subcutaneous, muscle, bone (ISO 10993-6)
Genotoxicity – in vivo (ISO 10993-3)
Hemocompatibility
Hemolysis - Plasma Hb , % Hemolysis
Platelet function – collagen /ADP
Platelet activation by flow cytometry
Platelet secretion – ELISA
Coagulation
Complement activation
Histopathology
Gross and histopathological evaluation (ISO 10993-6)
Gross & histopathology evaluation – soft and hard tissue
Necropsy, grossing & tissue sampling, tissue processing, block making, microtomy, HE staining, special staining, qualitative microscopy
Immunohistochemistry
Microbiology
Sterility testing (USP 71)
Genotoxicity – in vitro (ISO 10993-3)
Antimicrobial activity
Bacterial adhesion studies
Bioburden analysis
Spore viability testing
Air monitoring
Microbiological analysis of water

Study mode evaluation

• Evaluations that are not regular and is tailor made to the customer, usually follow a study mode which will be carried out under the responsibility of study Director/s

• In case of study mode of evaluation after discussion with the customer and having an initial consensus on the protocol a study budget is intimated to the customer

• On mutual agreement on the budget the study protocol is sent to the customer.

• The customer is to sent the initial payment and also the study protocol with due approval.

• We always look forward to the visit of the customer to monitor the progress of the study as these are long term evaluations The following study mode evaluations are examples to quote:

• In vivo biofunctional evaluation of devices in large animal models
• Microbiological evaluation
• IC50and in vitro glucose uptake study
• Acute toxicity studies
• Gross and histopathological evaluation
• Efficacy study on small animals
• Hepatotoxicity studies
• In vivo efficacy studies in small animals
• Drug release profile studies etc

Preclinical large animal evaluations

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. Animals provide a valuable testing system anatomically, physiologically or even pathologically because of their phylogenetic closeness to humans. Experience & expertise in the evaluation of critical cardiovascular and neurosurgical products&sophisticated facilities is our asset. Expertise include evaluations of cardiovascular devices like drug eluting coronary stents, heart valve, PDA closure devices etc, neurosurgical devices, respiratory devices, dental materials, orthopaedic implants, ophthalmic implants etc.

Calibration Cell

Establishing metrological traceability to international standards (SI) is a crucial prerequisite for global recognition in any systems or processes, whose reliability critically depends on measurements. To address this requirement, Calibration Cell (CAC) as an in-house facility was formed at SCTIMST in the year 2000. Calibration Cell, SCTIMST offers a comprehensive range of high-quality calibration services, all of which are directly traceable to the nationally / internationally recognised primary measurement standards. Most of these services are accredited by the National Accreditation Board for Testing & Calibration (NABL) to ISO 17025.

Excess capacity of calibration services is also offered to reputed external customers. CAC undertakes customised studies for the system validations, with respect to metrological parameters of sterilization systems and other medical device developments. CAC also offers skill development training and internships for professionals with engineering backgrounds.

Overview of Calibration Cell Activities

Calibration Cell, SCTIMST coordinates the calibration and traceability requirements of the Institute. The Calibration Cell carries out these activities using its in house capabilities and where ever required, coordinates with the external agencies to meet the requirements. Reference materials are maintained by the cell for ensuring traceability of measurement to national / international standards. Calibration Cell also undertakes calibration work at customer site. Instruments such as Electronic Balances Ovens, Water baths, Humidity Chambers, Temperature Indicators etc., can be calibrated at customer site.

Calibration services are accredited by National Accreditation Board for Testing & Calibration Laboratories (NABL) in the following fields,

• Mechanical
• Thermal and
• Electro-technical