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New types of therapies in the pharma industry require a turnaround time of 2-4 days. To reduce risk of contamination during production, traditional microbial detection methods fall short, as the incubation period is at least 5 days and the actual microbial level is underreported.
This guide introduces the following topics:
- A new process control strategy for rapid microbial detection
- Regulatory views on use of rapid microbial methods
- 7000RMS Microbial Detection Analyzer
The limitations of the plate count method have required a rethinking of the microbial monitoring strategy to ensure processes are always under control, thus reducing risk of contamination. Rapid Micro Methods (RMMs), including for the water used for the process, are key to this overall process control strategy. While plate counts confirm water quality at the end of the incubation period, knowing that the process is under control using measurements from RMMs allows pharma companies to minimize the risk of releasing product within the required turnaround time.
The METTLER TOLEDO 7000RMS Microbial Detection Analyzer provides improved process control and production efficiency. It offers continuous bioburden monitoring with results every two seconds, allowing optimization of system processes. The 7000RMS Microbial Detection Analyzer offers the following advantages:
- Control product quality with high sensitivity: Count individual microorganisms down to 0.3 μm in size.
- Minimize risk and reduce cost: Real-time monitoring eliminates waiting period for results. Trending data enables ability to react prior to an out-of-specification event.
- Global compliance: Regulatory agencies encourage the use of alternative, rapid microbiological methods for overall control strategy.
