Sterility Assurance Testing
ServicesTestingSterility Assurance TestingInfinity Laboratories provides comprehensive sterility monitoring and sterility 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 comprehensive solutions from our state-of-the-art sterility testing labs. Whether you are developing a medical device or a pharmaceutical drug product, Infinity will help you ensure product safety and compliance with all regulatory standards.
Infinity Laboratories provides comprehensive sterility monitoring and sterility 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 comprehensive solutions from our state-of-the-art sterility testing labs. Whether you are developing a medical device or a pharmaceutical drug product, Infinity will help you ensure product safety and compliance with all regulatory standards.
Sterility Testing of 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).
Sterility Testing of Pharmaceutical 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 sterilization validation services to help ensure the safety and efficacy of a wide range of sterile and nonsterile drug products.
Sterility Assurance Tests and Standards
Infinity provides a comprehensive range of sterility assurance testing solutions throughout all phases of development and manufacturing. All tests are conducted under standards set by the United States, European, and Japanese pharmacopeias and standards bodies, including the ISO, ASTM, and AAMI.
Bioburden
Bioburden
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)
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)
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
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
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
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
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.
Mycoplasma
Mycoplasma
Standard: USP <63>
Tests for mycoplasma contamination in biopharmaceuticals using both traditional and contemporary assays.
Particulate Matter
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
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.
RNase/DNase
RNase/DNase
Standard: USP <1125>, USP <1126>
Conducted to remove contaminating genomic RNA and DNA from pharmaceutical drug products.