We can help and guide you through the complete process starting from the development of the Environmental Monitoring (EM) program up to analysing your results and if needed investigating Out-of-Specification results.
Environmental monitoring is a critical process within the pharmaceutical and biotechnology industries. EM highlights 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.
Depending on your needs, our experts will use their many years of experience to support you setting up and implementing a cost effective, efficient, and GMP compliant Environmental Monitoring Programme.
We offer the following services:
Compliant with GMP annexes, ISO 14644, USP <1116>
Customised services are also available. Contact us to find out whether we can help. Our team will be happy to assist.