Do your CAPAs get closed? Eurofins Sinensis, fully GMP certified, can help you get your cleanroom under control and ensure compliance with guidelines. We can help and guide you through the process from A to Z: starting with the development of the Environmental Monitoring program up to analysing your results and if needed investigating Out-of-Specification Results.
About our EM services
Environmental monitoring is a critical process within the pharmaceutical and biotechnology industries. EM highligths conditions contributing to excessive microbial levels due to ineffective cleaning, or personnel/equipment issues. Using EM you are able to determine the microbial content of cleanroom air and surfaces. The air is monitored by using both the active and passive monitoring method. For the passive method, settle plates are used to monitor viable airborne particulates. For active monitoring the airborne particulates are monitored by using an air sampler. Finally, for surface-bound particulates RODAC plates are used.
EM services available
Depending on your needs, we offer the following services:
- Development of Environmental Monitoring program
- On-site sampling
- Training of your personnel on-site
- Incubation, analysis and report of the EM samples
- Identification of EM isolates
- Houseflora determination
Custom services are also available. Contact contact us to find out whether we can help. Our team will be happy to assist.
- Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Standard and custom solutions. If our standard solutions do not fullfil your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.