Ensuring Data Integr...
4th November 2019 Content supplied by: Rapid Micro Biosystems
Growth Direct System Provides Validation to Perform Pharmaceutical In-process Bioburden Analysis
Pharmaceutical in-process testing can be a significant percentage of the workload in the microbiological QC department. Each microbial sample test is divided into 2 phases: first sampling/setting up the test and secondly reading and recording the test result(s). The second phase involves a trained analyst performing the very repetitive task of data collection and collation for which they may be overqualified.
A reduction in both the time to results, and the analyst involvement on the sample analysis would be a benefit to the micro QC department. Both of which can be obtained by the introduction of automation to this process. Linking automation to a 2-way LIMS system to control sample work-lists and result upload removes time-consuming, laborious tasks from the analyst.
Learn more about the validation of a Rapid Micro Method (RMM) system as an automated colony counter when applied to Pharmaceutical in-process bioburden testing.
Date Published: 4th November 2019
Ensuring Data Integrity Using PDA