Infinity Laboratories Products & Solutions

Infinity Laboratories Products & Solutions

Sterility Assurance Testing

09 Dec 2022

Lab Tech Sterility Assurance 2
Infinity Laboratories has over 30 years’ experience helping our customers in the medical device industry deliver safe and effective products to market.  Patient safety is our top priority, and we offer a full suite of support testing to assist you with regulatory compliance.  We stand behind the quality of our results, the strength of our partnerships, and have the experience and capabilities to support your testing needs.  Our network of laboratories provides the critical sterility assurance testing services that are required by medical device and biotech companies to support both sterile and non-sterile products.  We complete rigorous validations to ensure that every medical device we test meets the requirements for your products by complying with ISO, ASTM, AAMI, USP and other standards.

Bioburden tests are used to determine the total number of viable microorganisms that are on or in a medical device, component, package, or container. This testing is required by many standards and acts as an early warning system for problems in controlled areas that could lead to issues with inadequate sterilization.

Lab Tech Sterility Assurance 3

Microbial identification (micro IDs) systems play an important role in environmental monitoring, contamination investigation, and cleanroom control by identifying potentially harmful bacteria, yeast, and fungi.  Threat of contaminants can be mitigated through microbial surveillance.  When unwanted contamination does occur, the microbe’s identity is necessary to know the source and steps to contain and minimize growth.

Product Sterility and Biological Indicator Sterility (BI) testing is a critical piece of any sterility assurance program.  We offer testing in traditional cleanrooms and which are then validated by performing a method suitability test (Bacteriostasis/Fungistasis or B/F).

LAL or Endotoxin testing is an in vitro assay used for the detection and quantification of bacterial endotoxins (USP <85>).  This test is performed as lot release requirement for medical devices with direct or indirect contact with the cardiovascular or lymphatic systems or with cerebrospinal fluid.  Routine monitoring of incoming raw materials and water systems for bacterial endotoxins will ensure that your processes aren’t contributing endotoxins to your finished device or product.

Sterilization processes can leave residuals of the sterilant on the product following the sterilization process. For processes such as Ethylene Oxide (EO), the assessment of sterilant residuals, aeration time and safe levels are required. Infinity Laboratories provides sterilant residual testing for EO Residuals

We continuously work to enhance and protect patient lives through the critical testing services that we provide.  We believe we can make a difference in the lives of patients worldwide.  Our goal is to go Beyond Testing and become a partner in the success of our customers.