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> Learn about product sterility testing and its critical role in ensuring medical devices are free from viable microorganisms.

Source: https://lso-inc.com/sterilization-validation-services/validation-testing-services/sterility-testing/

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# Product Sterility Testing for Medical Devices

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FDA-Registered

Manufacturing Facility

ISO 13485

Certified Quality System

12 Cleanrooms

Class 5–8

125,000+ Sq Ft

Regulated Manufacturing

3 Facilities

CA | NH | Costa Rica

ISO 17025

Accredited Packaging Lab

![Bacterial Endotoxin Testing in a Sterile Lab Environment](https://lso-inc.com/api/media/file/bacterial-endotoxin_001-4.jpg)

## What is product sterility testing?

Sterility testing is used during validation to detect the presence of viable microorganisms that may remain in or on a medical device after undergoing a sublethal sterilization process. This type of testing is necessary to determine if the fully sterilized device will be sterile and safe for use.

## Who needs product sterility testing?

Medical device manufacturers use sterility testing to validate their sterilization process parameters.

![loaner-kit](https://lso-inc.com/api/media/file/loaner-kit-3.jpg)

## How does sterility testing work?

Sterility testing requires controlled procedures to detect remaining viable organisms in or on a sterilized medical device:

**Preparation**

Representative samples are collected from each batch. Sample size is determined by batch size and regulatory requirements. Then testing is performed in a controlled environment like a cleanroom to prevent contamination.

**Testing methods**

The samples are then tested using one of two methods: Direct inoculation, or membrane filtration, each of which has several options.

**Interpretation of results**

The results are either negative (no growth) or positive (growth). If  microbial growth is detected, an investigation may be triggered to determine any source of contamination and potential corrective actions.

**Documenting and reporting**

This step involves record keeping of all observations, test conditions and results, and detailed reporting about the samples tested, methods used, incubation conditions, and results.

**Regulatory compliance**

The final step is validation and routine testing for regulatory requirements, and quality assurance to demonstrate quality standards compliance.

## What standards apply?

[ISO 11737-2](https://www.iso.org/standard/70801.html) and USP <71> have guidelines on how to perform sterility tests.

## Validation Testing Services

## Ready to get started?

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