Medical devices or other medical products may carry some microorganisms if they have not been subjected to any sterilization process after production, even though they are produced in the sterile environments required for their production. The size and population of these microorganisms on the product after production is called “Bioburden amount.” The test applied to the product to determine the amount of this bioburden is known as the bioburden test. As a result of the Bioburden test, medical devices must be packaged by packaging systems to maintain the level of cleanliness stipulated by the medical device regulation.
The main purpose of the test to determine the amount of microorganisms on medical devices and medical products is to minimize the risk of microbiological contagion. For this purpose, there is a statement similar to the following in the Medical Device Regulations: “Packaging systems for non-sterile medical devices must be such that they maintain the prescribed level of cleanliness without deterioration of the medical device. "If medical devices are to be sterilized before use, it should be in a way that minimizes the risk of microbiological contamination." With this principle, the bioburden test we carry out in our laboratories complies with the ISO 11737-1 standard.
Bioburden testing is performed to evaluate the microbiological integrity of products during production processes and before or after sterilization. This test is performed to evaluate the risk of microorganism contamination of products.
At the Beginning of Production: In the early stages of the production process, bioburden testing is performed to evaluate the microbiological status of production equipment and materials.
During Production: Tests are carried out at regular intervals to control bioburden levels during production, especially before sterilization and packaging of products.
Sterilization Validation: Before the sterilization process, a bioburden test is performed to determine and verify sterilization parameters.
Pre-Sterilization Control: Before sterilization, a bioburden test is performed to evaluate the microbiological integrity of the products and to check their suitability for the sterilization process.
Sterilization Validation: After the sterilization process, a bioburden test is performed to verify the effectiveness of sterilization.
Post-Sterilization Control: Bioburden test is performed to evaluate the microbiological integrity of the products after sterilization and to evaluate the risk of contamination after the sterilization process.
Bioburden test is performed for the purpose of quality control and quality assurance of the products.
Bioburden testing is performed between reprocessing or additional sterilization processes of the products.
According to the microbiological data obtained from the Bioburden test result, it is learned whether the product has a valid sterilization or not. If the product does not have a valid sterilization method, the methods used to sterilize it are determined according to this test result. Sterilization studies are determined by taking into account the number, size and type of living organisms on the product. These methods are generally manual or automatic shaking, vortexing, disintegration, washing and swab methods. These methods are applied until the prescribed cleaning level is reached. After applications, the product can be tested again.
Bioburden is also concerned with the sterilization of the product before use. In many ways, microorganisms may be present on the product just before use. The best way to protect the product from these organisms is to keep the products in as sterile environments as possible.
This bioburden before use may spread to other patients or healthcare professionals through air or contact in environments where healthcare services are provided, such as clinics and operating rooms. This increases the risk of infection in these environments. Therefore, bioburden is an issue that needs to be taken into consideration not only before but also after a product reaches the market.
ELISA (Enzyme Linked Immunosorbent Assay): This test method is used to measure the presence of antigens or antibodies.
PCR (Polymerase Chain Reaction): Polymerase Chain Reaction is used to detect the presence of microorganisms by rapidly amplifying DNA or RNA fragments.
Mass Spectrometry: Mass Spectrometry is used for the direct detection and identification of biological substances.
Military Applications: Military service members may be vulnerable to biological attacks. Bioburden tests quickly detect whether military service members have been exposed to biological agents, allowing the necessary treatment to be initiated quickly.
Civilian Health: In the event of a biological attack or natural epidemic, bioburden tests play a critical role in protecting public health and preventing the spread of the epidemic.
Clinical Diagnosis: Bioburden tests are used in the diagnosis of some infectious diseases and in the management of treatment processes.
As Saniter Laboratories, we offer comprehensive testing services to ensure that food, cleaning products and medical devices comply with quality and safety standards before they are released to the market. We carry out tests in our laboratory with advanced technologies and experienced experts to determine whether our customers' products and devices comply with industry standards. These services include the bioburden test, which is applied to evaluate the reliability and effectiveness of medical devices. Bioburden test is a critical test to determine whether medical devices are contaminated during the production process or in use. This test is important to verify the effectiveness of the device sterilization process and whether the device is ready for use.
Saniter offers high quality, reliable and timely results to its customers with its bioburden testing service. We offer solutions that meet the needs of our customers with our experienced experts, state-of-the-art equipment and comprehensive laboratory.
You can prove to consumers that the products you offer are of the highest level of reliability and quality by taking advantage of Saniter’s bioburden test service for the safety and quality of your products.
Do not hesitate to contact us for more information and service requests.
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