Real-Time Bioburden Monitoring in Pharmaceutical Water (Video)
Have you ever experienced microbial contamination that led to an out-of-spec event, water system quarantine, or product recall even though you perform routine testing?
How much time and cost did it take to investigate or undo this damage? Even with false positive results, it’s often too late.
The water loop has to be sanitized, rinsed, retested and the affected product may be a total loss.
While plate counting is a regulatory requirement, there are inherent risks and delays that can greatly impact the accuracy of test results. Let’s take a look at these risks…
No matter how careful you are, contamination can still occur at any stage of sampling. Waiting 5-7 days to get results causes you to use “at risk" water without knowing the microbiological quality. A sample you take now could yield very different results than a sample was taken minutes or hours later. Sampling too infrequently can also cause you to miss an excursion. You can only count what will culture and colonies you can actually see. Such variables and limitations can mislead your assessment of the water quality.
What if you could reduce these risks with a complementary test method? Instead of capturing snapshots that are a week old with sampling, you could have full visibility of your process with continuous, real-time monitoring. When used in parallel with plate counting, the 7000RMS real-time microbial detection analyzer can help you react quickly to any trend or excursion before it becomes an event. Giving you complete process transparency for minimized risk and real-time water release.
The 7000RMS advanced laser-induced fluorescence technology provides a direct cell count of microorganisms present in pharma-grade waters. Overcoming limitations of growth-based laboratory methods that are an estimation of microbial presence and dependent on time and incubation conditions.
Counts microorganisms from as small as 0.50 microns and accepts direct input line temperatures of up to 90ºC. The 7000RMS delivers 24/7 monitoring of water treatment, storage tanks, distribution loops, points-of-use, and clean-in-place processes.
Applications: Continuous monitoring of PW, WFI, and UPW.
Source: Alliance Technical Sales on YouTube