Sterility Testing

Ensure the safety and regulatory compliance of your medical devices with advanced sterility testing services. Our ISO and GMP-certified laboratories provide reliable sterility testing for surgical instruments, catheters, implants, and single-use devices as per USP, IS 10150, and ISO 11737 standards. Trusted by manufacturers and exporters worldwide, we deliver accurate results with quick turnaround times. Safeguard patient health and meet global regulatory requirements through validated, contamination-free sterility testing.

Method Ref.: ISO 11737, IS 10150, USP

TAT : 14-15 Working Days

Required sample quantity : Min. 20 test units per product/batch*

Method Reference

ISO 11737, IS 10150, USP

Turnaround Time

14-15 Working Days

Sample Quantity

Min. 20 test units per product/batch*

₹2,500 ₹3,500/ sample

NABL Accredited ISO 17025:2017 Signed Report

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Testing Scope

About This Test

Sterility testing in medical devices is a critical quality control process that ensures products are free from viable microorganisms. It is essential for devices intended to be sterile, such as surgical tools, implants, catheters, syringes, and other invasive or implantable medical equipment. This testing is conducted under controlled conditions using methods prescribed in pharmacopeias such as USP <71> and ISO 11737-2. The process typically involves direct inoculation or membrane filtration to detect microbial contamination. Sterility testing plays a vital role in patient safety, regulatory compliance, and overall product efficacy.

Why It Matters