Microbiological tests monitoring

Monitoring for successful therapy is critical in this serious infection to prevent complications, prevent resistance development, and decrease mortality. Routine assessment of clinical signs and symptoms, as well as laboratory tests (i.e., repeat blood cultures), microbiologic testing and serum drug concentrations, must be performed. 

Accordingly, installation qualification and operational qualification of the sterilizer and validation of the processes, combined with continuous monitoring of each individual routine process, are now considered fundamental. Therefore, sterility tests (i.e., microbiological tests performed on the final product) have lost much of the significance they had in the past, ... 

Due to the rapid advancement of new pharmaceutical delivery systems, this chapter covers only a limited number of techniques. Several of the techniques listed below may be necessary only at time zero or at release rather than being monitored at each stability time point. In addition, this chapter does not cover microbiological tests such as microbial limit, pyrogen, and sterility testing. 

Microbiological testing is performed to monitor the microbiological bioburden and to ensure that the final product complies with the regulatory microbiological specifications. It comprises ... 

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