Microbial Ingress Testing Service
The introduction of microbial contamination in medical equipment and sterile medicines can increase the risk of patient infection. The microbial ingress testing can evaluate the integrity of sterile product packaging and verify whether the container closure system has a reliable barrier to microorganisms. In the research and development stage of the sterile product packaging system, microbial ingress testing is required to confirm the integrity of the packaging system. Creative BioMart Microbe provides technical outsourcing services for microbial ingress testing for sterile drug containers and closed systems, sterile barrier packaging of medical devices, and in vitro diagnostic reagents.
Package Integrity Evaluation
Sterile drug containers and closed systems, sterile barrier packaging of medical devices, and in vitro diagnostic reagents all involve testing the integrity of product packaging to confirm that the packaging system can prevent the intrusion of microorganisms. The integrity evaluation of sterile product packaging runs through the product development, production, and shelf-life stability evaluation stages. Product packaging integrity testing in the R&D phase needs to take into account the extreme conditions encountered during the production and sterilization process. Sterile product packaging integrity testing includes physical testing and microbial testing. Microbial ingress testing is necessary in the product development stage. Comparing the data of the microbial integrity test and the physical integrity test can determine whether the product packaging with the physical integrity test value within the acceptable range will have microbial invasion, that is, the comparative evaluation of the product.
Microbial Ingress Testing
Microbial ingress testing for sterile drugs generally first fill the sample with a sterile growth support medium, and then culture and visually inspect the sample to ensure that the sample is sterile before the test. The sample is immersed in the bacterial suspension, and the immersed sample is exposed to positive pressure conditions for a specific period of time (or exposed to alternating cycles of vacuum and overpressure). Then, the sample is cultured under conditions that promote growth, and after the culture is completed, the contents of the package are checked for microbial growth.
The introduction of microorganisms may occur in multiple processes, including processes such as production, packaging, storage, and transportation. In addition, taking into account the differences in product design, sterilization process, and product intended use, the integrity test methods applicable to different product packaging systems are also different. We provide personalized solutions for specific products, and customize test programs for different products to ensure reliable and effective research results. At the same time, we can also conduct comparative evaluation research based on customer needs.
Why Choose Creative BioMart Microbe?
- Customized test solutions for different products
- Accurate and reliable test results and detailed test reports
- Cost-effective solution
Workflow of Microbial Ingress Testing Service in Creative BioMart Microbe
If you want to know more information about microbial ingress testing service, please feel free to contact us by phone or email, or you can consult through our inquiry form. We will ensure to provide you with efficient and high-quality experimental outsourcing services.
