Case Study Bioburden Analysis for Process Control Reduces Plate Counting Costs and Delays 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 offline testing to continue to monitor the water system and find the root cause. However, this method did not provide enough process transparency to make operational decisions. 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. Repeated plate counts led to delayed product release During the pharmaceutical manufacturing process, one of the biggest challenges is achieving timely product release while ensuring the product is safe for consumers. A major bottleneck in manufacturing is microbial contamination testing of the 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 outof-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. With these process delays in mind, the customer started to explore ways to reduce the time to product release while also controlling process costs. As they investigated ways to streamline