Microbiology Testing (Medical Devices)

Microbiology Testing (Medical Devices)

To avoid microbial growth in medical devices, microbiological testing including Bacterial Endotoxin Testing (BET), Sterility, and Bioburden tests are essentially required. These tests ensure that devices intended for patient contact are sterile and safe for use.

Our NABL accredited laboratory performs all tests per USP, EP and ISO 11737 standards, providing reliable data to support device release, sterilization validation, and regulatory submissions.

Tests Performed

• Sterility Testing (USP <71>, EP 2.6.1, ISO 11737-2)
• Bacterial Endotoxin Testing — BET / LAL test (USP <85>, EP 2.6.14)
• Bioburden Determination (ISO 11737-1)
• Bioburden on Incoming Components
• Environmental Monitoring (cleanroom air and surface sampling)
• Microbial Limits Testing
• Container Closure Integrity Testing

Device & Product Types

• Single-use sterile medical devices
• Implantable devices
• Surgical instruments and equipment
• Parenteral drug delivery devices
• Ophthalmic devices
• Dialysis products
• In-vitro diagnostic devices

Why Microbiology Testing is Critical

Medical devices in direct contact with patients — especially those entering sterile body cavities or the bloodstream — must be completely free of viable microorganisms. Even low levels of bacterial endotoxins can cause life-threatening reactions in patients.

Standards & Accreditation

All microbiology testing is performed per ISO 11737-1 and ISO 11737-2, USP <71>, USP <85>, EP 2.6.1, EP 2.6.14, and ISO 13485 quality management requirements. Our NABL accreditation ensures internationally recognized test results.