Water for Pharmaceutical use
AQU@Sense MB. Online Water Bioburden Analyzer.
Water is indispensable for pharmaceutical production processes. Water is omnipresent as raw material or as part of the final manufactured product. Therefore, hygienic quality is crucial for human health. Take control of the microbiological quality of your pharmaceutical water supplies with the AQU@Sense MB, the first alternative method for online bioburden analysis that was successfully validated.
Validation is the key for new technologies to be accepted in pharmaceutical manufacturing. bNovate and BWT achieved the primary validation as the first step in the overall validation process. Proving that AQU@Sense MB is suitable for monitoring pharmaceutical water purification processes and, depending on the application, it can even be used for release testing.
Results are delivered within minutes instead of days, which allows you to react rapidly in case of contamination and to save money with maximizing your instrument uptime and production workflows. This rapid microbiological method (RMM) is a new standard for microbial surveillance and can be validated according to the European Pharmacopoeia (Ph.Eur.) and United States Pharmacopeia (USP).
Challenges in the Pharma Industry
In Process control
Having a global overview and control every step of the production
Monitor all process steps from incoming water to the final product for bioburden
Identify early signs of contamination with microorganisms to take preventive actions
Reduce water sampling and associated testing costs
Ensure the constant quality of the elaborated product
Speed up release with immediate understanding of
the microbial water quality
Reduce the risk of an out of specification product
Automated cleaning equipment of all lines with data-driven CIP triggering
Decrease the energy and chemicals consumption
Minimize Production downtime
Reduce samples analyzed to ensure the safety of the installation
" We have assessed AQU@Sense MB in hot and ambient WFI +PW water systems. General impression is that this Online Water Bioburden Analyzer (OWBA) has the best differentiation between inert particles and living microorganism."