Sterility Assurance Testing Services 

For pharmaceutical and medical device manufacturers, ensuring that a product is sterile is one of the most critical steps in protecting patient health and meeting regulatory requirements. Sterility assurance testing provides the data and validation needed to demonstrate that products are free from viable microorganisms and safe for use.

Sterilization is the process of eliminating all forms of microbial life—including bacteria, fungi, and spores—from a medical product or pharmaceutical. This step is essential for products that come into direct contact with patients or sterile body sites.

Common sterilization methods include steam, ethylene oxide (EtO), radiation, and moist heat. Selecting the right approach depends on the product’s materials, design, and intended use. Understanding the sterilization process helps manufacturers align their products with both safety expectations and regulatory standards.

Sterility testing methods are designed to confirm that sterilization processes are effective and consistent. At Canyon Labs, we provide a full suite of sterility assurance services to support your device or drug product, including:

• Verification of sterilization cycle effectiveness.
• Testing aligned with the target sterility assurance level (SAL), typically 10⁻⁶.
• Methodologies that meet international regulatory requirements, ensuring global compliance.

Our lab teams specialize in tailoring testing protocols to the unique challenges of both single-use and complex combination products.

Partnering with Canyon Labs means more than checking a compliance box—it’s about building confidence in your product’s safety. With our experienced team, you can:

• Validate your sterilization approach with precise, reliable data.
• Demonstrate compliance with FDA, EMA, and ISO standards.
• Accelerate your product development timelines by avoiding costly rework.
• Protect patients and strengthen your reputation in the market.

At Canyon Labs, we help you achieve your target sterility assurance level with proven methodologies and unmatched regulatory expertise.