Sterility Assurance/ Microbiological Safety
MDTL provides a comprehensive range of microbiological services in support of facility and product monitoring for medical devices. We help clients fulfil special requirements either by standardized test designs or tailor-made studies.
Our microbiological services for medical devices include:
Sterility Testing
The Product Sterility is necessary for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms. The cleanroom is a classified space where lab analysts are equipped with special gowns and precautions to not add bioburden to the test area where they perform aseptic manipulations of products to test for sterility. To optimize aseptic transfer of samples into the test media, all testing is performed in an ISO Class 6 cleanroom. Utilizing advanced technology such as a double airlock system and unidirectional airflow to ensure a sterile work environment.
This test is performed according to the recommendations from
- USP 71
- USP 797
- EP 2.6.1
- JP 14 54
- ANSI/AAMI/ISO 11737
- AAMI TIR33
Determination of Endotoxins
The Bacterial Endotoxins Test (BET) is an in vitro assay for detection and quantitation of bacterial endotoxins, a component of the cell wall of gram-negative bacteria. The BET is performed as part of the lot release testing for medical devices with direct or indirect contact to the cardiovascular system, lymphatic system, or cerebrospinal fluid. Injectable pharmaceutical products must also be tested for bacterial endotoxins. Routine monitoring of water systems and incoming materials can help to ensure that the process does not contribute endotoxins to the final product.
This assay is also known as the Limulus Amebocyte Lysate (LAL) test and is sometimes referred to as the pyrogen test (because bacterial endotoxins can cause a fever in mammals, including humans). However, the BET should not be confused with the rabbit pyrogen test described in USP chapter <151>.
Estimation of Bioburden
The Bioburden Test determines the total number of viable microorganisms in or on a medical device, container, or component. It is performed on any product that requires control and/or monitoring of bioburden counts, usually as part of a sterilization program. This test acts as an early warning system for possible production problems that could lead to inadequate sterilization. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.
MDTL Labs performs this test in accordance with ISO 11737-1 and is most commonly referenced in the Radiation Sterilization standards (ISO 11137-1 & 2) and the EO Sterilization standard (ISO 11135).
- Specified Microorganism / Microbial Limit Testing
- Identification of Microorganisms
- Environmental Monitoring
- Process Water Testing
- Analysis of Bioindicators
- Validation of Sterilization Processes, including Dose Audits for Irradiation Sterilization
- Validation of Depyrogenation Processes
- Validation of Test Methods
- Evaluation of Reusables for the Intended Reprocessing Procedure (Cleaning, Disinfection, Sterilization).
