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Medical Device Testing Services

Biocompatibility Testing

Biocompatibility is essential to ensure that medical devices do not trigger harmful biological reactions upon contact with the human body.

Active Air Sampling

This test captures airborne microorganisms onto growth media using impaction methods, offering more sensitive detection than passive techniques.

Assay of Residual Solvents – Volatile Impurity Analysis

Samples of drug products or raw materials are prepared and subjected to analytical techniques to detect, quantify, and classify residual solvents.

Petri dish with microbial colonies from air monitoring

Microbial Air Monitoring

Using passive sampling (settle plates), this test detects microbial fallout over time to assess air hygiene in cleanrooms and aseptic areas.

Tablets in blister packs for shelf-life testing

Shelf-Life Testing – Stability & Expiry Determination

Drug samples are stored under accelerated, intermediate, or real-time (long-term) conditions inside stability chambers.

Tablets moving along a pharmaceutical production line

Fungal and Bacterial Contamination Testing

Samples are inoculated into or onto selective culture media and incubated under controlled conditions to encourage the growth of bacteria and fungi (yeasts and molds).

Petri dish with microbial colonies from environmental monitoring

Airborne Particle Count

This test evaluates the concentration and size distribution of particles in the air, supporting room classification & regulatory compliance under ISO 14644-1.

Earth Continuity Test

This test checks whether the metallic parts of a device are properly connected to the earth ground, ensuring fault currents are safely diverted.

Technician in cleanroom clothing operating testing equipment

Hardness Testing

Hardness testing measures the material’s resistance to deformation, helping evaluate durability and performance.

Jar of cream product sample for pH testing

pH Testing – Ensuring Product Stability, Safety, and Compliance

Prepared samples are measured using a calibrated pH meter, with test conditions depending on the specific dosage form.

Bioburden Testing

Bioburden testing estimates the number of viable microorganisms present on a product. This helps design and validate the sterilization process.

Leakage Current Testing

Leakage current refers to the small amount of electrical current that flows through unintended paths, such as to the device chassis or user.

Tracing wheel marking leather samples for flex resistance testing

Flexural Endurance Testing – Resistance to Repeated Bending

Material specimens are subjected to controlled flexing cycles using a flexometer under defined environmental conditions.

Leather being stitched on an industrial sewing machine

Tensile Strength Testing – Breaking Force & Elongation Analysis

Standardized specimens are cut and mounted in a Universal Testing Machine (UTM), which applies a gradually increasing tensile load.

EMC Emissions Testing

This test measures the electromagnetic radiation emitted by a product to ensure compliance with global EMI limits (e.g., CISPR 11, IEC 60601-1-2).

Comprehensive Test Matrix Across Key Sectors with Applicable Standards

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