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CMDC BIOCOMPATIBILITY TESTING
Even the finest designed products might result in unanticipated consequences if the materials employed provoke a biological reaction in the patient, making biocompatibility testing a crucial step in the regulatory clearance process for medical devices. When treated in a way that results in contamination, deterioration, or the leaking of harmful substances into a patient, well-characterized materials that are often used in the industry can produce unanticipated reactions.
CYTOTOXICITY
(TISSUE CULTURE)
In vitro cell culture assays using isolated cells can be used to evaluate the biocompatibility of a material or leachable. These procedures assess material toxicity and irritancy. They can also be used screen materials before in vivo experiments. At CMDC Labs, we can handle all of your Cytotoxicity testing needs.
BIOBURDEN AND STERILITY TESTING OF MEDICAL DEVICES
If you have a hands-on role in the manufacturing of medical devices, you’re likely familiar with bioburden testing. This crucial test, conducted after the completion of all pre-sterilization procedures, is essential for ensuring compliance with the FDA's stringent regulations for medical device testing. Adhering to this requirement helps guarantee that your devices meet the highest safety and quality standards.
At CMDC Labs, we are committed to providing top-tier microbiology testing services that are both reliable and comprehensive. Accredited under ISO/IEC 17025, our laboratory embodies a standard of excellence recognized globally. Our skilled team of scientists and state-of-the-art technologies are devoted to delivering accurate, timely, and actionable results to support your diverse needs.
Numerous techniques, such as scratch assays, cell-exclusion zone assays, microfluidic-based assays, and Boyden Chamber assays, can be used to analyze cell migration. The CMDC Labs proprietary CT Chamber Test is the only cell migration method that can be used to test the surface of a medical device. This can be used to test cellular reaction to a surface, immune response to a surface or bacteria reaction to a surface.
CELLULAR PROLIFERATION ASSAYS
Commonly used methods for assessing cellular viability, proliferation, and cytotoxicity are used to evaluate how well cells in culture are responding to diverse stimuli. The right assay method should be chosen based on the number and type of cells being employed as well as the expected results.
ACUTE SYSTEMATIC TOXICITY
The Acute Systemic Toxicity test identifies leachables that cause systemic (as opposed to local) harmful effects by analyzing extracts produced following exposure to the device or device material. Mice are injected with test material extracts and a negative control blank (intravenously or intraperitoneally, depending on the extracting media).
THE KEY CONCEPTS IN BIOCOMPATIBILITY TESTING
By definition, biocompatibility is a measurement of how well-suited a device is to a biological system. Biocompatibility testing is done to verify if a device is fit for human usage and to see if there could be any possible adverse physiological impacts from using it. The International Organization of Standards has declared: “The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising from the use of medical devices.” (ISO 10993-1:2009)
18S RNA SEQUENCING
To identify, categorize, and quantify microorganisms in complex biological mixes, such as samples taken from the environment and the gut, 18S rRNA gene sequencing is frequently used. Different eukaryotic 18S rRNA gene sequences can be used to build a phylogenetic tree, which can be used to examine the genetic diversity and historical ties of eukaryotes.
What is the Difference Between 16s VS 18s rRNA
The main distinction between 16s and 18s rRNA is that 16s rRNA is a part of prokaryotic ribosomes’ 30S subunit whereas 18s rRNA is a part of eukaryotic ribosomes’ 40S subunit. An essential part of ribosome structure is ribosomal RNA, or rRNA. The process of protein synthesis includes rRNA. Eukaryotes and prokaryotes have different ribosomes.
WHY DO WE PERFORM 16S RNA SEQUENCING?
The 30S small subunit of a bacterial ribosome contains the approximately 1500 base pair 16S ribosomal RNA (also known as 16S rRNA). The role of 16S rRNA in a bacterial ribosome is depicted in Figure 1A. Nine hypervariable regions (V1-V9) with 30-100 base pair ranges are present in the bacterial 16S rRNA gene and are flanked by conserved regions (Figure 1C). The Ribosomal Database Project (RDP), Greengenes database, Silva, and Human Microbiome Project (HMP) have 16S rRNA sequences for microbial identification.
INTRODUCTION TO BIOCOMPATIBILITY
The term “biocompatibility” describes how a medical device interacts with a patient’s tissues and physiological systems while being used to treat them. One aspect of a device’s overall safety review is an assessment of biocompatibility. Analytical chemistry, in vitro experiments, and animal models are used to examine the biocompatibility of devices. A device’s biocompatibility is influenced by a number of factors, including…
HEMOCOMPATIBILITY
Intravenous catheters, hemodialysis sets, blood transfusion sets, vascular prostheses or any medical device that comes in contact with the blood stream must be tested for blood compatibility. In practice, all materials are, to a certain extent, incompatible with blood because they can destroy blood cells (hemolysis), activate coagulation pathways (thrombogenicity) and/or the complement system.
IMPLANTATION TESTS
The biocompatibility of medical devices or biomaterials that directly contact living tissue (e.g. sutures, surgical ligating clips, implantable devices, etc.) other than skin is evaluated via implant studies. These tests can assess medical devices that are intended to be implanted for either short- or long-term use in clinical settings. It is possible to test absorbable and non-absorbable materials using implantation procedures.
IRRITATION TESTS
Irritation studies gauge a device material’s propensity for local irritation utilizing locations like the skin or mucous membranes, typically in an animal model. Although the exposure route (skin, eye, or mucosa) and duration of contact should be similar to the device’s anticipated clinical use, it is often times beneficial to moderately exaggerate exposure conditions in order to provide patients with a margin of safety.
HUMAN CELL TESTING SERVICES
CMDC Labs cell culture lab provides in vitro bioanalytical services for research and drug development. Crucial steps including functional screening and validation testing of surfaces and substances on the activity of cell culture in a controlled environment. This highly desirable and direct evaluation of cell tissue needs specific resources, expertise, and time. From beginning to end, CMDC Labs streamlines this procedure, freeing up our clients to concentrate on other important facets of their research.
ZONE OF INHIBITION TESTING
The effectiveness of an antibacterial treatment on a surface or product can be quickly assessed using a Zone of Inhibition (ZOI) test. The procedure, formerly known as the Kirby-Bauer test, was developed as a result of pharmaceutical industry research on antibiotics, and was later used to evaluate the antibacterial capabilities of polymers and textiles.
Certificate of Accreditation
At CMDC Labs, our commitment to excellence is demonstrated through our Certificate of Accreditation. This certification reflects our adherence to the highest industry standards and our dedication to providing reliable, accurate testing services.
