Sterility Assurance Testing

Infinity Laboratories provides comprehensive sterility monitoring and validation services throughout your product’s lifecycle to verify the presence or absence of microorganisms and support patient safety. We work as an extension of your team to provide sterility assurance for medical devices and pharmaceutical drug products, ensuring product safety and compliance with all regulatory standards

Medical Devices

Infinity works with our partners to support the sterility of their medical devices. Sterile medical devices can be defined as devices without bioburdens, and sterility can be quantitatively expressed as 10-N where the higher the value of N, the higher the assurance of sterility. Infinity offers method development, EO sterilization, and validation services to remove microorganisms and measure your device’s sterility assurance level (SAL).

Pharmaceutical Drug Products

Infinity has the technology and experience to understand your pharmaceutical drug product and create a comprehensive contamination control strategy (CCS). Our team provides sterilization and sterility assurance method development and validation solutions for sterile and nonsterile drug products.

Sterility Assurance Tests and Standards

Infinity provides a comprehensive range of sterility assurance testing solutions through all phases of development and manufacturing. All tests are conducted under standards set by the United States, European, and Japanese pharmacopeias, as well as standards bodies, including the ISO, ASTM, and AAMI.


Standard: USP <61>, AAMI/ANSI/ISO 11737

Also referred to as “Total Viable Count Testing,” this test is conducted under ISO 11737-1 standards and measures the microbial contamination levels in or on a product.

BI Testing (BI Sterility)

Standard: ISO 11135, 11138

Biological Indicator (BI) Testing is conducted using an indicator organism to audit the effectiveness of sterilization and provide a high degree of sterility assurance.

BI Testing (Population Verification)

Standard: USP <55>, ISO11138

Verifies the spore population on a BI before the sterilization process so your final product can be properly sterilized and assayed before use.

Cleaning Residuals

Standard: ASTM F3127-16

Conducted to validate the cleaning process of a medical device and identify the presence of excess cleaning residue.

Endotoxin/LAL/Pyrogen Testing

Standard: USP <85>

Detects bacterial endotoxins on medical devices or pharmaceutical injectables using Limulus amebocyte lysate (LAL), which have been prepared for use as an LAL reagent.

EO Residuals

Standard: AAMI 10993-7

Conducted after EO sterilization, determines the presence and quantity of sterilization residues such as ethylene oxide (EO), ethylene chlorohydrin, and ethylene glycol using gas chromatography.

Microbial Identification

Standard: Vitek®, MicroSEQ

Detects the presence of microorganisms in a pharmaceutical drug product using either the Vitek® or MicroSEQ Rapid Microbial ID Systems.


Standard: USP <63>

Tests for mycoplasma contamination in biopharmaceuticals using both traditional and contemporary assays.

Particulate Matter

Standard: USP <788>, <789>

Conducted on sterile injectable pharmaceutical drug products and certain medical devices to detect, quantify, and remove particulate contaminants.

Product Sterility

Standard: USP <71>

Conducted to detect microbial contamination in a life science product after sterilization to validate product sterility utilizing dual incubation temperatures.


Standard: USP <1125>, USP <1126>

Conducted to remove contaminating genomic RNA and DNA from pharmaceutical drug products.

Get in Touch

Want to learn more about our sterility assurance services? Connect with one of our team members today.