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A major influenza vaccine manufacturer in the US was concerned with intermittent positive plate counts on its water system. These results led to more frequent off-line testing to continue to monitor the water system and find the root cause.
But this did not provide enough process transparency. The customer turned to the 7000RMS™ analyzer for continuous bioburden monitoring to get better insight into their process while reducing the costs of multiple plate countings and product delays.
This case study discusses a major bottleneck in pharmaceutical manufacturing: microbial contamination testing of process water to ensure it does not contaminate the final product. The traditional method of microbial tests – plate counting – takes five to seven days to give a result, during which time the product must be quarantined. This method only provides a snapshot in time of the water loop, potentially missing out-of-specification events. Moreover, if a plate count produces a positive result, the test is usually repeated to confirm the contamination and then further investigation is required, leading to more delays.
The 7000RMS Microbial Detection Analyzer offers many advantages:
- Results every two seconds – improves process control and production efficiency
- Counts individual microorganisms down to 0.3 μm in size – controls product quality
- Real-time monitoring eliminates the waiting period for results – minimizes risk, and reduces costs
