Medical Device Microbiology & Sterility Testing

Sterilization is the process of removing micro-organisms. Sterility test is defined as a Microbiological test applied to the sterile products to show are products manufactured and processed under specification guided by cGMP or to confirm the products either sterile or non-sterile. Sterility test is applied to substances, preparations, or articles required to be sterile. This test is suitable to reveal the presence of a viable form of bacteria, fungi, and yeasts in medical devices.

USP and EP describe two primary types of culture media to be used in the sterility testing of parenteral products: Fluid Thioglycollate Media (FTM) and Soybean Casein Digest Broth (SCDB), FTM is used for detection of aerobic and anaerobic bacteria while SCDB is used for detection of molds and yeasts.

"Medical devices–Quality management systems-Requirements for regulatory purposes", the harmonized standard for quality management systems of medical devices (ISO 13485), gives out the general considerations that should be taken into account when evaluating the auditing processes of a medical device. It outlines the requirements of the quality management system for the design and manufacture of medical devices.

STEMart offers comprehensive sterility test for sterile, non-pyrogenic products. With extensive expertise in Microbiology & Sterility testing, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks.

Our Microbiology & Sterility testing services

Antibiotic Potency Test >

We offer Antibiotic Potency Test to assess the bioactivity or potency of various antibiotics for your medical devices.

Antimicrobial Preservative Effectiveness >

We offer Medical Device Antimicrobial Preservative Effectiveness testing to assure the antimicrobial action induced by a medical device is sufficient to combat the introduction.

Biological Indicator-Population Verification >

We offer Biological Indicator Population Verification testing service to help manufacturers to assess the number of spores on a biological indicator.

Biological Indicator-Sterility Testing >

We offer Biological Indicator-Sterility testing services for medical devices to yield results of either growth or no growth of the appropriate indicator organism.

Microbial Identification & Strain Typing >

We offer Microbial Identification & Strain Typing services, performed following the bioburden, environmental monitoring, tissue testing, microbial limits, and on sterility or BI.

Impurities Identification >

We offer Impurities Identification service to evaluate the impact of impurities on the medical devices quality and safety.

Tissue Testing Services >

We offer the Tissue Testing Services to determine the total number of viable microorganisms in or on a tissue product or solution.

Limulus Amebocyte Lysate (LAL) >

Our LAL service is performed as a lot release test, determining the presence of bacterial endotoxins by testing the blood cells of horseshoe crabs to identify pyrogenic.

Bioburden and Sterility Testing >

We offer the Bioburden test to determine the total number of viable microorganisms in or on a medical device, container, or component.

Reprocessing Validations >

We offer the Reprocessing Validations to ensuring your products and instruments are clean and sterile every time they come into contact with a patient or end user.

Disinfection Validations >

We offer Disinfection Validations for reusable medical devices to assurance that your products meet FDA’s disinfection validation requirements.

Particulate Matter >

Particulate Matter testing includes procedures for removing, counting, and sizing particulate contaminants in medical devices.

Ethylene Oxide Sterilant Residual Tests >

We offer the EO Residuals Analysis to identify and quantify the ethylene oxide, ethylene chlorohydrin, and ethylene glycol by gas chromatography.

Radiation Quarterly Dose Audits (QDAs) >

We offer the Radiation Sterilization Validation to determine the appropriate radiation sterilization dose for a product that requires a sterile label claim.

Rapid Endotoxin Testing for Medical Devices >

We offer Rapid Endotoxin Testing services for quick and quantitative endotoxin analysis of your medical devices.

STEMart performs cost-effectiveness full services that deliver reliable results for your medical devices. Our experts can evaluate the medical device to propose an appropriate plan for testing to ensure your medical device meets the required regulatory compliance. If you have any additional questions about Microbiology & Sterility testing or would like to consult with the experts at STEMart, please feel free to contact us.

Reference

ISO 13485: 2016 "Medical devices - Quality management systems - Requirements for regulatory purposes".

Medical Device Microbiology & Sterility Testing

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