The microbiological characteristics of medical devices for clinical use are closely related to the life safety of patients. Microbial contamination carried by medical devices may cause the user and patients to bear the risk of infection and endanger life and health. Therefore, it is necessary to conduct microbiological evaluation of medical devices to determine the reliability of product quality.
In order to ensure that medical equipment meets microbial safety requirements, relevant regulations have formulated specifications and recommendations for microbiological testing of medical equipment. For example, for invasive medical devices, endotoxin testing is necessary, while for reusable medical devices, it is recommended to perform cleaning verification, disinfection verification and sterilization verification. Reliable microbial testing can help medical device manufacturers ensure that they produce medical devices that meet regulatory standards.
Bioburden testing is to test the microorganisms (including bacteria, yeasts and molds) on medical equipment before performing the sterilization process. Bioburden testing is often used in sterilization verification procedures. The bioburden test mainly detects the total number of aerobic microorganisms and specific microorganisms.
For medical equipment with sterility requirements, sterility testing is required. Creative BioMart Microbe established a sterility test platform based on the USP sterility test method, which includes a sterility test system and professionally trained sterility test technicians. We can provide customers with suitability testing and verification testing services.
Endotoxin is a pyrogen released when the cell wall of gram-negative bacteria ruptures. It can cause severe symptoms such as fever and diarrhea in the human body. Therefore, endotoxin testing is necessary for medical devices with invasive applications. Our endotoxin testing services include gel clot method, kinetic turbidimetric method and kinetic chromogenic method.
The packaging integrity of medical equipment will affect its microbiological characteristics, especially for medical equipment with sterile requirements. The packaging integrity testing service provided by Creative BioMart Microbe will simulate external conditions such as environmental pressure to determine whether the packaging performance of the product meets the requirements.
Cytotoxicity testing is also an important part of the quality control of medical equipment, which helps to screen biomedical materials or equipment. We provide direct contact, agarose overlay, MEM elution, and MTT assay for cytotoxicity testing.
Creative BioMart Microbe has established a set of advanced and complete microbial identification platforms, including MALDI-TOF mass spectrometry identification and sequence analysis identification and other identification technologies, which can provide customers with fast and accurate identification results.
Biofilm is the main cause of microbial contamination of medical equipment. We provide customers with multiple biofilm-related testing and research services.
Creative BioMart Microbe has a team of experts with rich experience in medical equipment testing. We can provide customers with accurate and reliable microbial test results in a relatively short time. For many years, Creative BioMart Microbe has been providing customers with satisfactory microbial services and has established a stable cooperative relationship.
If you are looking for services related to microbial testing of medical devices, please feel free to contact us. Creative BioMart Microbe looks forward to being your trusted long-term partner.