USP Validation Conf...
10th December 2024 Content supplied by: Micronview Ltd
Coming Soon from MicronView
- Micronview's online water bioburden analyzer (WBMS) to be launched in 2025.
- Industry partners are invited to join our pre-market user experience program to provide valuable insights and feedback.
Water is the primary raw material used in pharmaceutical manufacturing, playing a critical role in every stage of production, from equipment preparation to the creation of final commercial products. In a typical aseptic manufacturing facility, approximately 9% of total testing involves grab-sample analysis of water.
Pharmaceutical water requires routine monitoring and control for parameters such as conductivity, total organic carbon (TOC), bioburden, and endotoxins, depending on its intended use. Currently, bioburden monitoring relies on periodic manual sampling, plating, and traditional microbiological methods, which can take several days to yield results. Online water bioburden analyzers aim to address this by providing real-time, continuous data on water systems, enhancing process understanding and reducing risk in real time.
Modern online water bioburden analyzers leverage advanced technology that utilizes the intrinsic biochemical auto-fluorescence of microorganisms under laser excitation. Commercial systems typically employ a 405 nm laser to excite biological molecules like NADH and picolinic acid, detecting the emitted fluorescence. These systems can analyze both air and liquid samples, with the moving sample stream passing through an optical cell. The analyzer continuously monitors parameters such as detection frequency, particle size, and bio-fluorescence. This bio-fluorescence particle counting technology offers the ability to detect changes in manufacturing air or water systems in real time, delivering substantial benefits as a process control tool.
MicronView is set to launch its new bioburden analyzer, WBMS, in late 2025. We invite industry partners to join our pre-market user experience program to provide valuable insights and feedback. If you are interested in participating in our user experience program, use the Request Information button below to contact us.
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Date Published: 10th December 2024
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USP Validation Confirms BAMS as