Quality

REGULATORY TESTING OF MEDICAL GRADE PLASTICS, RUBBERS & PACKAGING MATERIALS

1. Physical & Mechanical testing (As per BIS, EN, ISO & ASTM standards)

It includes Tensile and hardness testing, Scratch Resistance, Material fatigue testing, Static and fatigue product testing, Grain size evaluation, Microstructure analysis (phase analysis, etc.), Surface evaluations (alpha case, anodization) and Corrosion testing.

Tensile testing per ASTM E8 is routinely performed to evaluate cast, forged, and additively manufactured medical devices such as hip stems and knee femurs, and to verify mechanical properties of post-processed samples and materials. Tensile properties of titanium and cobalt chrome samples provide insight into how implants and materials will perform in service and are related to other mechanical properties such as fatigue and fracture toughness.

Equipment required for Physical and Mechanical testing are DSC (Differential Scanning Calorimetry), DMTA/DMA (Dynamic Mechanical Analyzers), TMA Thermomechanical Analyzers), TGA (Thermogravimetric Analyzer), HDT (Heat Desorption Temperature) and Universal Testing Machine.

2. Chemical testing (As per BIS, EN, ISO, ASTM & 21 CFR standards)

General chemical tests includes Molecular Weight (MW) of Polymers, Structure & Chemistry of fractions, End groups & Tacticity, Unreacted monomer and oligomers, Co-polymer content and blend composition, Catalyst residues, Contamination analysis, Chemical trace analysis and Plastics and Polymers volatile organic compounds testing.

Medical devices components chemical testing includes Identification of Extractable and Leachable chemicals, Forced Degradation Studies and Degradation Product Characterization, Stability studies including Accelerated and Stressed, Chemical and bio-analytical Characterization of Proteins, Peptides and Macromolecule Therapeutics, Specialist Surface Analysis and Surface Imaging, Integrated Study Management, Pre-clinical and Stage 1, Bio-analytical and Immunochemistry investigations, Pharmacopoeia Testing for Quality Control, Medical Device Polymer Materials Testing, DEHP and BPA Testing for Health Canada Medical Device Licensing, RoHS Testing Services.

3. Microbiological testing (As per BIS, EN, ISO, USP & ASTM standards)

Microbiological testing of a medical device refers to tests for the presence and risk of microbial contaminants. Methods may include mainly the testing of bio burden levels (Bio burden is a quantitative testing in which we only detect number of colony forming units (cfu)), Presence of endotoxin (Bacterial Endotoxin test, also known as Limulus Amebocyte Lysate (LAL, which assesses medical devices coming in contact with cerebrospinal fluid or the cardiovascular system), and methods for sterility assurance.

Microbiological testing also includes Biofilm test, Anti microbial test, Sterility testing (Sterility testing of medical devices are typically performed using media called SCDM (Soybean -Casein Digest Medium), which is physically placed in the media for fourteen days of Incubation time) & Microbial Barrier test. Sterility assurance of medical devices is one of the requirements set forth by global medical device regulations. Ensuring consistent microbiological testing during manufacturing is imperative to product quality and patient safety. All injectable and implantable devices need to be tested for endotoxin prior to being inserted into the patient. While the process of preparing a medical device for endotoxin testing and the endotoxin limit may vary from device to device.

4. Biological Safety testing for raw materials (As per IP/BP/EP/JP/USP standards)

Raw materials of Medical devices includes PVC beads, HEPE beads, silicon, nylon, paper, Rubber beads, rubber closures, resin, coating material etc.

For raw material of medical device, biological safety study can be done by various compendial method given by IP/BP/EP/JP/USP.

There tests includes - In-vitro cytotoxicity test

- Intracutaneous reactivity test
- Acute systemic toxicity test
- Implantation test

Over and above, some regulatory agency also asked for Material mediated Pyrogen Test (Using Rabbit) & abnormal toxicity test.

5. Biocompatibility testing of Raw Material / Components of Medical device (As per ISO 10993-1:2018 standards)

Risk & Toxicological assessment helps to understand the biological safety profile of the medical device product. Biological Safety testing is an assessment for biological effects from the exposure of a medical device or material to human body can include testing such as cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, implantation and haemocompatibility, etc.

As per ISO 10993-1:2018, New MDR (for CE), USFDA and CDSCO, below mentioned testing required:

• Cytotoxicity testing (ISO 10993-5:2009)
• Sensitization testing (ISO 10993-10:2021)
• Intracutaneous test / Irritation testing (ISO 10993-23:2021)
• Acute systemic toxicity (ISO 10993-11:2017)
• Material mediated Pyrogen test (ISO 10993-11:2017) Additionally in case of prolonged / long term exposure of component / device with the body, below mentioned additional testing are also required:
• Chemical Characterization Test (ISO 10993-18:2020)
• Extractable & Leachable Test (ISO 10993-18:2020 & ISO 10993-17:2002)
• Implantation test (ISO 10993-6:2016)
• Sub-acute / sub-chronic/ chronic toxicity test (ISO 10993-11:2017)
• Genotoxicity test (ISO 10993-3:2014)
• Hemocompatability testing (ISO 10993-4:2017)
• Degradation & Toxicokinetic (ISO 10993 -16:2014)
• Carcinogenicity test (ISO 10993-11:2017)
• Reproductive toxicity test (ISO 10993-11:2017)
• Biological Risk Assessment (ISO 10993-1:2018)

Raw materials of Medical devices includes PVC tubes, Silicon Tubes, Nonwoven fabrics, HME filter, Packaging materials etc.

6. Packaging testing of Raw Material / Components of Medical device (As per BIS, ISO & ASTM standards)

All sterile medical devices require validation of their packaging. The sterile barrier must be shown to be effective throughout the product's claimed shelf-life.

According to ISO 11607-1, the specific properties of medical devices and their packaging systems must remain stable during their shelf life. Afterward, products can be subjected to various test systems in order to evaluate the performance of the packaging system, aseptic presentation and microbial barrier properties, as well as the performance of the containing medical device, functionality and biocompatibility. Validation of the packaging processes, such as the forming and sealing process of sterile barrier systems, pursuant to ISO 11607-2. In the course of a combined stability and packaging validation study, sterilized and final-packed test devices are subjected to both thermal and regular aging and to transport simulation, pursuant to ISTA or ASTM standards.

Packaging testing of raw material includes Dye test for Seal strength & integrity, Peel test, Burst test, Bubble test, Air permeability test and test for microbiological tightness, Qualification of packaging materials, Validation of the forming, sealing and assembly processes of packaging for terminally sterilized medical devices, Validation of final packaging systems for sterile medical devices, Evaluation of the shelf life of the sterile packed medical device, Stressed medical devices are subjected to specific performance tests as well as to a biological evaluation test strategy.