The bioburden test is a microbiological analysis performed to determine the number of viable microorganisms found on non-sterile products prior to sterilization. This test forms the basis of sterilization validation and ensures the correct definition of the sterilization parameters to be applied. Since the microbial load on the product directly affects sterilization efficacy, bioburden analysis is of critical importance for the microbiological safety of medical devices.
IVBIO conducts these tests in full compliance with the TS EN ISO 11737-1 standard and the European Pharmacopoeia (EP) 2.6.12. The methods used are optimized according to the product's structure, intended use, and the planned sterilization method.
During the analysis process, microorganisms are removed from the product surface or internal structure using appropriate techniques; samples obtained via shaking, washing, or swabbing methods are inoculated into appropriate culture media. Microorganism growth is monitored during the incubation period, and colonies formed are counted to determine the average microbial load on the product.
Bioburden test results guide the correct selection of sterilization parameters (e.g., temperature, time, gas concentration). Furthermore, they provide scientific evidence showing that the microbiological contamination risk in production processes is under control.
IVBIO performs all its analyses using validated methods, calibrated devices, and under laboratory conditions compliant with ISO standards. The test duration, including incubation and reporting, takes an average of 8 days. Results are presented in a detailed report format suitable for use in sterilization validation files.
You can contact IVBIO for more information.
The sterility test is an analysis performed to verify whether sterilized medical devices or biotechnological products are microbiologically completely sterile. This test is one of the most important validation steps proving the efficacy of the sterilization process and scientifically documents the product's microbiological safety.
IVBIO conducts sterility tests in full compliance with international standards and pharmacopoeias. Tests are applied according to TS EN ISO 11737-2, European Pharmacopoeia (E.P.) 2.6.1, and United States Pharmacopeia (USP) 71 standards. Thus, globally valid results compliant with European and American regulations are obtained.
Two main methods are used in sterility tests:
IVBIO performs all tests under aseptic conditions, with validated methods and calibrated devices. Environmental conditions, media validations, and device calibrations are meticulously controlled. The test duration, including incubation and reporting, takes an average of 15 days.
The obtained results offer internationally valid scientific evidence that can be used in sterilization validation, process control, and product safety files. Additionally, IVBIO provides technical consultancy support to manufacturers regarding sterilization validation and microbiological safety processes.
You can contact IVBIO for more information.
The Bacterial Endotoxin (LAL) Test is performed to detect toxic lipopolysaccharide (LPS) structures belonging to gram-negative bacteria that may be present in products. Since these components can lead to serious reactions such as fever, inflammation, or septic shock when they enter the human body, the test is a critical safety parameter, especially for medical devices, pharmaceuticals, and dialysis systems that come into direct or indirect contact with the body.
IVBIO conducts bacterial endotoxin tests based on the Limulus Amebocyte Lysate (LAL) method, in full compliance with ISO 11737-3, European Pharmacopoeia (E.P.) 2.6.14, and United States Pharmacopeia (USP 85) standards. In this way, the results have international validity.
During the analysis process, samples taken from products are reacted with LAL reagent. In the presence of endotoxins, gel formation is observed (gel-clot method), and results are evaluated. Thus, it is verified whether the product's endotoxin level is within safe limits for human use.
The test plan is customized according to the product's area of use, contact type, and regulatory requirements. All analyses are carried out with calibrated devices, validated methods, and within the scope of the quality management system.
The bacterial endotoxin test is an indispensable part of sterilization validation and production process control. IVBIO offers manufacturers not only testing services but also technical consultancy on biosafety and regulatory compliance.
The test duration, including incubation and reporting, takes an average of 5 days.
You can contact IVBIO for more information.