Biomaterial Testing Services

About Biomaterial Testing Laboratory:

A systematically and pharmacologically inert substance designed for implantation within or incorporation with the living system is a biomaterial.

Biomaterials can be derived either from nature or synthesized in the laboratory using a variety of biochemical approaches utilizing metallic components, polymers, ceramics, or composite material. These biomaterials are often used for various medical applications such as joint replacements, artificial ligaments, and tendons, heart valves, intraocular lenses, vascular grafts, nerve conduits, etc.

The medical devices, implants, and any allied material can be in contact with the body of the patient for their lifetime. The material should be able to maintain its structure and integrity for predictable periods, hence the material has to be thoroughly examined for its compatibility, performance, and safety requirements.

Our Biomaterial Testing Laboratory (BTL) is equipped to test biomaterial in terms of nature of the material, physiochemical evaluation, histopathological evaluation, mechanical strength evaluation post and pre-implantation, sterility and several other tests.

TÜV Rheinland India operates testing facilities as per ISO and guidelines set by the National Health Systems Resource Centre, Government of India.

Technical regulations prescribed within the national guidelines have been implemented for the testing of biomaterial. TUV Rheinland works in alignment with the standard protocols set by national and international standards in accordance with ISO 10993 series of standards.

Testing within our Biomaterial testing laboratories includes:

Physio-chemical Evaluation - This evaluation of the bio-material helps to understand the biochemical nature of the material intended to be implanted such as identification, quantification, degradability, 3D evaluation, topographical characterization. Our lab is equipped with top-end equipment such as X-Ray Diffractometer, Micro-Computerized Tomography, Scanning and Transmission Electron Microscopy (SEM and TEM), Raman Spectrophotometer, Fourier-Transform Infrared spectroscopy (FTIR), Confocal Microscope and Dynamic Mechanical tester (DMA).

Histopathology Laboratory - The standard test methods will be used for the histopathology of the samples collected, prior to and after implantation of any device or implant. The examination of serum, grafts, and any related material will be conducted in our well-equipped histopathology laboratory. The laboratory includes equipment such as tissue processor, microtome, tissue embedding system, autostainer, trinocular, and microscope.

Sterility Evaluation - The sterility evaluation is one of the crucial steps that a device or implant has to pass through. Our Biosafety Level-III Facility helps to evaluate product safety in terms of parameters such as sterility, stabilizability, and bio-burden on the device or implant.

Other Testing Facilities - TÜV Rheinland has established our Medical Device Centre of Excellence at Visakhapatnam. The facility helps manufactures to get tested and certified their products which in turn will expand their market share. Apart from the Biomaterial Testing Laboratory, TÜV Rheinland facilitates testing for accelerated Aging, Package, Validation, Electrical and Environmental, Radiation Safety, Acoustic and EMI/ EMC which provides complete testing solution for your products.The facility contains Semi Anechoic Chamber (10 meters), Humidity Chambers, Thermal Shock, and High Ramp Chambers, Multi-Torsion Tester, Torque Testing Machine, High-Speed Pneumatic Impact Tester, Vickers Micro hardness Tester, etc.

Biomedical Devices or Implant - The BTL is established to test diversity of the biomedical devices and implants so that it can help the stakeholders increase their market share and facilitate the invention of innovative, simple, and next-generation medical aids. The BTL can work in association with innovators for customized testing methods that help both stakeholders and us.

The biomaterial applications listed below can be tested in BTL according to stakeholder requirements:

• Bone Joint Implants
• Bone Plates and Cement
• Intraocular Lens
• Contact Lens
• Heart Valves
• Vascular Grafts
• Breast Implants

Biomaterial that can be tested in our laboratory:

• Hydrogels
• Silicone rubber
• Stainless steel
• Nanoparticle material
• Alloys
• Cellulose
• Coating material
• Hydroxyapatite
• Collagen

Chromatography - Our high throughput chromatography facility establish proof of identity for your biomaterial.

Our specialized material analysis services render:

• A complex mixture of organic and inorganic compounds can be analyzed by High-performance liquid chromatography (HPLC)
• Unknown material can be identified by FTIR spectrophotometer, FT-Raman, and GC-MS
• Quantification and Speciation of metals by ICP-MS
• Determine relative molecular weight by GPC (Gel permeation Chromatography)

Our high-end optical microscopy facility enables visualization deep within both living and fixed cells. Laser Scanning Confocal Microscope captures live cells without any damage, helps tissue engineering, and regenerative medicine. The state-of-the-art facility is also equipped with a wide field confocal microscope for surface profiling.

Our specialized material analysis services render:

• Gellation studies to improve texture performance in the food Industry
• Targeted delivery and controlled release studies in complex biopolymer systems
• The spatial location of active materials in spray-dried flavor ingredients
• Characterization of film-forming polymers as a development tool in the coatings industry
• Regenerative medicine
• Ligand Binding properties
• Tissue engineering and adhesion studies
• Fluorescence In-situ Hybridization

Renders atomic-level imaging solutions ranging from the cellular level to protein and viruses.Transmission Electron Microscope (TEM) with cold Field emission Gun, EDS, and STEM helps to find out structural arrangement till the micro molecule level.

Our Electron microscope analysis renders:

• Local structures and Morphology
• Dispersion of Multicomponent polymers
• Cross-section and crystallization of metals and alloys
• The microstructure of composite material
• Elements of samples using EDS
• Electron diffraction
• Nanoparticle size distribution

Ultrastructural Microscopic procedures enable the visualization of unique details of the Biomaterial. Our new age Scanning Electron Microscope (SEM) with Energy Dispersive X-ray Spectrophotometer (EDS) images even high moisture-biological samples with elemental footprints.

Our Ultra Microscopic facility renders:

• Evaluation of Tissue/medical device Interface
• Elucidation of ultra-structure of Bio-material
• Porosity and pore size of the material
• Surface topography/structure
• Elemental analysis
• Elemental mapping of Alloys, Natural and Synthetic Material

Our new version, the DXR Raman Microscope gives you true confocal depth profiling abilities, enabling you to look for evidence of inclusions or impurities and characterize multi-layer polymer films.

Our DXR Raman Microscope renders:

• Rapid and non-destructive sample analysis
• No sample preparation is required
• No water interference – easy to measure aqueous samples
• Complementary to FT-IR
• Easy access to low vibrational frequencies, making it easy to analyze inorganic molecules
• Polymers – inclusions and gel defects, weathering effects, tie layers in laminates, and crystallinity
• Pharmaceutical – polymorphs, particulate contaminants, and diffusion studies
• Nanotechnology – characterize graphene, CNTs, DLC coatings, and other nanostructures

Micro-CT is a 3D X-ray imaging system on a small scale with high resolution, which represents a 3D microscope.

Our specialized material analysis services render:

• Reliable measurements without any detours
• X-ray once, evaluate anytime
• Metrological competence in all components
• Metrological examination
• Volume fractions and Fraction analysis
• Distance measurements
• Composite material examination such as Carbon fiber, polymer mixes, Bone Implants, dental implants, electrical aids

TÜV Rheinland provides testing services for Protective Face Masks which comply with national and international standards including Indian standards such as IS 16289 for surgical masks alongside of EN 14683 and ASTM F2100. TÜV Rheinland's state-of-the-art Biomaterial Testing Laboratory ensures the safety and quality of Protective Cloths, Face Masks, Surgical Coveralls and COVID-19 Coveralls remain uncompromised. We provide solutions for three distinctive types of face masks - Surgical, non-surgical and non-medical Masks along with surgical coveralls and protective coveralls. Our multi disciplinary facility at Andhra Pradesh MedTech Zone-Visakhapatnam, India undertakes over twenty EN/IS/ASTM/ ISO standards for testing.

TÜV Rheinland’s Medical Textile Testing Laboratory located in Andhra Pradesh Medtech Zone (AMTZ) in Visakhapatnam has been recognized by the Bureau of Indian Standards (BIS) for testing Protective Face Masks as per Indian Standards such as IS 9473: 2002, IS 16289: 2014 and IS 17334: 2019. The scope covers:

• Filtering Half Masks to protect against particles (PPE masks)
• Surgical Face Masks and
• Surgical Gowns and Surgical Drapes

Our experts ensure compliance of Face Masks and Medical textiles in accordance with Indian testing and certification requirements. Bacteria Filtration Efficiency, Paraffin Filtration, NACL Filtration, Flammability, Synthetic Blood Penetration, Breathability and other performance, mechanical, biological, biocompatibility tests are part of our evaluation. The facility is also offers testing services according to various international standards like EN 149, EN 14683 and ASTM standards.