AQU@Sense MB

Monitors the microbiological quality of PW & WFI.
Fast and accurate.

The system for the continuous measurement of total cell count (TCC) in critical utilities for Pharma & Biotech.

 

The quality of Purified Water (PW) and Water for Injection (WFI), defined in USP and Ph. Eur. must be demonstrably impeccable at all times. Regular monitoring is mandatory. The microbial quality of water is a quality parameter, which is still determined offline by the use of solid nutrient media.

Preparing the sample, plate and agar, and the final count is time-consuming and prone to errors. At the same time, the process is slow due to the necessary incubation period of 5 days. Because of this long "time-to-result", the method offers no real time process control.

 

The microbiological quality is the only crucial parameter that is exclusively determined offline. This feels like an anachronism, especially when compared to other relevant parameters as TOC and conductivity, which are primarily monitored online. Multiple documents, as the USP <1223>, Ph. Eur. 5.1.6 and the PDA TR No. 33, advocate the complementary use and the validation of rapid microbiological methods (RMM) such as the AQU@Sense MB.

 

The AQU@Sense MB counts the actual bacterial cells (TCC) present in water, accurately - in minutes. Even bacteria which are in a stress-induced state, that cannot be cultivated (called VBNC), are detected by this flow cytometer. Additionally, the method is impartial to incubational and nutritional requirements. According to the USP <1223>, only 1% of the present bacteria are recovered with heterotrophic plate counts (HPC), when compared to flow cytometry. This emphasizes the benefits of the technology used for BWT’s new RMM.

 

The AQU@Sense MB is the solution for reducing labor and cost-intensive plate counts, with minimum effort and low cost per sample. A short time-to-result provides timely information in case of a microbial excursion and allows immediate reaction.

 

The device can be used in two different measuring modes, which make it relevant for a wide range of operators: continuous, measurement for process monitoring or grab sample analysis for the control of multiple POU. The HMI is highly user-friendly and displays the main results clearly while still offering detailed data for in-depth analysis by microbiologists.

 

The highlights at a glance:

  • Continuous monitoring of the microbiological quality of PW & WFI improves process safety, control and understanding
  • Precise measurement of bacterial cells (TCC)
  • Time savings for immediate search for causes & reactions
  • Rarer sanitizing and direct verification of efficacy
  • Freedom of choice for automated continuous and manual sampling